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® Capabilities and professional highlights Innovation Undertaking scientific research and creating technology that will provide better solutions, transform the eye care of the future and Licensing improve peoples’ lives everywhere Translating our science into commercially viable products and solutions Education Developing and delivering a range of eye care courses to teach different skills Public Health from the community level to professional development Building local and sustainable systems – with local people trained to deliver quality eye care services Who we are Brien Holden Vision Institute is a non-profit global, scientific, research, innovation, education, licensing and public health organisation, dedicated to providing creative and advanced solutions to ensure the provision of excellent vision for everyone, everywhere. Brien Holden Vision Institute is a social enterprise, investing the revenues from its work into translating our science into solutions and developing and delivering eye care and education programs around the world. Our commercial entities, the Brien Holden Vision (BHV) companies, are bringing products to market that will improve eye care and generate revenues for our mission. 4 Brien Holden Vision Institute Capabilities and professional highlights Mission: Vision for everyone...everywhere Through science and technology, research and development, education and public health initiatives, we will develop and implement, globally, new and better solutions for vision care and blindness prevention that will improve the quality of peoples’ lives and help reduce disability and poverty. Values •Sight is a fundamental right for all humans; vision excellence for all people is our obligation. •Our passion for science and innovation is driven by the pursuit of knowledge that will create resources and solutions to benefit all humanity. •Our behaviour is influenced by global collaborations, local partnerships and cultural understanding, and the core principle of sustainability. •Our translational research is aimed at enabling better products that will enhance quality of life for all. Goals •To continue as the premier applied vision correction research institute in the world. •To provide excellent and equitable vision care solutions globally. •To be a leading centre for the advancement of optometry’s role in vision care, education and research. •To achieve sustained growth in revenues for research, education and public health through product development. •To establish and maintain best practices for motivating, managing and developing staff. ® ® Brien Holden Vision Institute Capabilities and professional highlights 5 Why we do what we do Myopia Uncorrected refractive error •1700 million people with myopia in 2010; 2200 million with myopia in 20201 •625 million people in 201410,18 •80%–90% of high school graduates are myopic in urban areas of Singapore, China, Taiwan, Hong Kong, Japan and Korea2 •U.S. – rise in the prevalence of myopia from 26%–43% among adults from 1971–72 to 1999–20043 •Myopia significantly increases the risk of cataract4 (3.3X for myopia >6.00D), glaucoma5 (14.4X for myopia >6.00D) and retinal pathology6 (7.8X for myopia >8.00D) •517 million with uncorrected near vision impairment (presbyopia)10 and 108 million with uncorrected distance vision impairment18 •Vision impairment due to uncorrected distance refractive error costs the world US$202 billion per year in lost productivity, direct and indirect costs19,20 •US$28 billion is the one-off cost of providing comprehensive eye care worldwide20 Child eye health •Myopic macular degeneration is the number one cause of blindness in Shanghai, China7 and Tajimi, Japan8; 6%–22% of blindness in various countries is due to myopia9 •1.4 million children worldwide are irreversibly blind for the rest of their lives21 Presbyopia •80% of what a child learns is processed through the visual system22 •1040 million people with presbyopia in 200510 •Quality of life impact of uncorrected near vision impairment (presbyopia) similar to uncorrected distance vision impairment11 •An estimated 19 million children are vision impaired (12 million due to refractive errors)22 Deficit of eye care practitioners worldwide Diabetic retinopathy •47,000 functional clinical eye care providers needed globally – to assess vision and eye health and prescribe corrective lenses needed to restore good vision20 •347 million people diagnosed with diabetes in 2008 (up to 50% of diabetes undiagnosed)12,13 •18,000 optical dispensers needed globally – to provide appropriate glasses20 •Diabetic retinopathy occurs in nearly all patients with type 1 diabetes and >60% of patients with type 2 diabetes during the first two decades of disease14 Contact lens comfort and visual performance •Diabetic retinopathy is the leading cause of blindness among working-age adults in the world.15 •5% of all contact lens wearers drop out annually due to discomfort or dryness23 Dry eye •140 million contact lens wearers in 2014; by eliminating discomfort and dryness the market could potentially grow to 190 million24 •Affects 5%–35% of the population; prevalence increases with age and among certain ethnicities16 •20% of presbyopes who drop out of contact lens wear annually do so because of poor visual performance24 •Artificial tear market globally is estimated to be US$2 billion by 201817 •20 million presbyopic wearers in 2014 could increase to 35 million by 2020 by improving visual performance24 Myopia (near-sightedness) and presbyopia (ageing sight) are two eye conditions that are rapidly having an immense impact on the visual welfare and social well-being of the world. It has been estimated that up to 60% of the world’s population require some form of vision correction for myopia, hyperopia, astigmatism, presbyopia (all ‘refractive errors’) or other clinical needs.25 Yet, over 625 million do not have the eye examinations and glasses they need to see for distance or near vision,10,18 162 million have avoidable vision loss due to untreated disease18 and, unnecessary blindness and impaired vision is not being comprehensively prevented. Furthermore, evidence is mounting that a major vision impairment and blinding condition – yet to be prioritized by the World Health Organization (WHO), the major NGOs and research agencies – known as myopic macular degeneration (MMD), will become the major cause of blindness in Asia and a growing threat for many other countries where the prevalence of myopia is on the rise. The numbers alone suggest an impending crisis. We believe there were around 1.7 billion myopes worldwide in 2010 and that this will increase to around 2.2 billion by 2020, with a significant number living in urban areas of Asia.1 The other major concern is for presbyopia, which affects over 1 billion people and is expected to increase to 1.5 billion by 2050.10 History In the early 1970s a group of researchers led by Professor Brien Holden at the School of Optometry, University of New South Wales (UNSW), began developing expertise in contact lenses – a relatively new form of vision correction at the time. Strong collaborations with international researchers followed and the group’s research output attracted industry funding, leading to further expansion and the establishment of the Cornea and Contact Lens Research Unit (CCLRU) at UNSW in 1976. Over the next four decades the group built a reputation as one of the leading contact lens and vision correction research centres in the world and spawned a number of global education and humanitarian initiatives. In 1985, the Institute for Eye Research was established by the founders of the CCLRU as an independent but still university affiliated, research organisation. While the CCLRU continued for some time it was the Institute that soon flourished, inheriting many of its researchers, expertise and reputation. In March 2010, the Institute for Eye Research was proudly renamed the Brien Holden Vision Institute in recognition of the outstanding contribution to eye care research and global public health of one of its founders, Professor Brien Holden. The group broadened its focus beyond vision correction products and in 1998 founded the International Centre for Eyecare Education (ICEE), with the objective of building eye care systems in developing communities to treat the 625 million people unnecessarily blind or vision impaired globally. This formally became part of Brien Holden Vision Institute in 2012. Along the way, Professor Holden and colleagues also established the Cooperative Research Centre for Eye Research and Technology (CRCERT) in 1991, followed by the Vision Cooperative Research Centre (Vision CRC) in 2003, both based at UNSW and attracting a global network of collaborators, to pursue major research and technology breakthroughs. Research breakthroughs and product development emanating from these organisations provided the impetus and a revenue stream for Brien Holden Vision Institute to Product development timeline 1972 Comfortable, well performing daily wear hydrogel spherical and toric lens (Zero 6® Hydron) 1975 1983 Extended wear soft lenses, co-designed Permalens® and Permaflex® extended wear soft contact lenses 1970 The Institute developed the first centre distance and centre near soft bifocal combination for treating presbyopia with concentric bifocal contact lenses (CooperVision) 1980 1990 1973 1985 - 1994 Endothelial response to contact lens wear Saw methods develop for the definition of the oxygen needs of the eye, methods of using and screening extended wear lenses which led to high Dk silicone hydrogel lenses, (CIBA VISION, Bausch & Lomb) move further ahead in creating improved ways of correcting vision, with a particular focus on the most common eye conditions – myopia, presbyopia, hyperopia and astigmatism. In 2010 a new stream of programs pursuing breakthroughs in contact lens comfort, treatments for myopia and presbyopia, and to enhance delivery of vision care to Aboriginal and Torres Strait Islander Australians and developing communities worldwide, began through a 5-year funding extension to Vision CRC from the Australian Government. Development of an ‘intelligent retinal camera’, a low-cost imaging technology that will accurately and rapidly detect, and eventually diagnose, sight-threatening conditions such as diabetic retinopathy and glaucoma, was initiated in 2012, when further funding was awarded. Outlook In 2015, funding for Vision CRC ended, with the legacy of nearly $100 million of Australian Government investment across both CRCERT and Vision CRC. The 1998 The silicone hydrogel invention, released initially by CIBA VISION as the Focus® Night and DayTM contact lens now accounts for more than 50% of soft contact lens sales globally research and industry networks, a significant percentage of the intellectual property, and expertise in managing collaborative projects, generated over 25 years, will transition to Brien Holden Vision Institute, the major participant in these organisations. Vision CRC research to be carried forward by the Institute includes the Intelligent Retinal Camera, Myopia Control and Accommodating Gel projects. Brien Holden Vision Institute is also pursuing breakthroughs in contact lens technologies for treatment of refractive errors, comfortable contact lenses that provide greater comfort than no lens, and advanced dry eye treatments. Furthermore, the Institute is extending its research scope beyond vision correction, including an exciting project developing a neuro-ophthalmic device (NODe), that can measure pupillary response and eye movements to aid in the diagnosis of a broad range of disorders affecting the visual system, including: concussion, stroke, brain tumour, Alzheimer’s disease, Parkinson’s disease and some psychiatric disorders. 2009 Our collaboration with CIBA VISION resulted in the AIR OPTIX® AQUA MULTIFOCAL contact lenses for correction of presbyopia which is now the largest selling multifocal in the US today Present In development: •new generation multifocal/ extended depth of focus contact lenses •innovative myopia control lenses •comfort enhancing moisture solutions for dry eye and contact lens care. 2000 2002 2010 Our soft toric contact lenses design for the correction of astigmatism were successfully launched as the Biomedics® Toric and later as the Biofinity® and Avaira® toric lenses MyoVisionTM spectacle lens was released by Institute partner, Carl Zeiss Vision. The spectacle lens was found to slow the progression of myopia by 30% in children with at least one myopic parent Our capabilities and professional highlights Innovation – Science and research Licensing Education – Human resource developement Public health – Sustainable service delivery •Achievements •Current products and outlook •Clinical research •Technology •Biological sciences •Chemistry •Intellectual property management •Commercialisation •Strategic partnerships •Investments •Professional education programs •Postgraduate research education •Brien Holden Vision Institute Academy •Education resources •Child eye health programs •Vision centres and outreach services •Social enterprise •Spectacle supply – Global Resource Centre ® Innovation Science and research Achievements Brien Holden Vision Institute has driven market trends through breakthrough technologies and collaboration. Product success •Our collaborative development with Ocular Sciences Inc. (now CooperVision) for soft toric contact lenses for the correction of astigmatism has seen what was previously an infantile market develop into a market that is now growing two times faster than that of spherical lenses. •Co-development of the silicone hydrogel polymer with CIBA VISION (now Alcon) has created a class of material that now accounts for more than 50% of the soft contact lens market in the U.S. •Development efforts in multifocal soft contact lenses with CIBA VISION (now Alcon) has seen that market segment grow from 5% to over 8%, and is forecast to grow by more than 50% per annum going forward. Sales accrued and royalties generated Sales from products co-developed by the Institute: •all silicon hydrogel contact lenses •CooperVision soft toric lenses •Alcon AIR OPTIX® AQUA MULTIFOCAL lenses … are expected to total $37 billion in the 20 years since release onto the market. Royalties returned to the Brien Holden Vision Institute on these products so far amount to around $200 million. 12 Brien Holden Vision Institute Capabilities and professional highlights Innovation Expertise Research achievements •Clinical evaluation of contact lenses, multipurpose solutions, spectacles, new instruments and techniques •Approximately 1100 peer-reviewed publications •microbiology •2014 Charles F. Prentice Medal – optometry’s highest scientific honour – awarded to Professor Brien Holden •cell and molecular biology •2013 Garland W. Clay Award from American Academy of Optometry for a manuscript published in Optometry and Vision Science that has been most widely cited in the world of scientific literature in the preceding five years.26 •biochemistry •immunology •chemistry •instrument design and development •precision optical and biomedical engineering •software development and engineering – especially in data and image acquisition and analysis •metrology work, specialising in ophthalmic and optical components and devices Landmark findings (5 most cited papers) •Holden BA, Sweeney DF, Vannas A, Nilsson KT & Efron N. ‘Effects of long-term extended contact lens wear on the human cornea’, Investigative Ophthalmology & Visual Science, Vol 26 Nov 1985. •Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JKG, Brian G & Holden BA, ‘ The incidence of contact lensrelated microbial keratitis in Australia’, Ophthalmology, 2008; 115:1655-1662. •Holden BA & Mertz GW, ‘Critical oxygen levels to avoid corneal edema for daily and extended wear contact lenses’, Investigative Ophthalmology & Visual Science, Vol 25 1984. •Naidoo KS, Raghunandan A, Mashige KP, Govender P, Holden BA, Pakharel GP & Ellwein LB, ‘Refractive error and visual impairment in African children in South Africa’, Investigative Ophthalmology & Visual Science, 2003;44:3764-3770. •optical modelling and design, including visual optics. Key collaborators •Bascom Palmer Eye Institute, University of Miami, U.S. •Dr Tom Aller, U.S. •Johns Hopkins University, U.S. •LV Prasad Eye Institute, India •Shanghai Eye Disease Prevention and Treatment Centre, China •University of Alabama at Birmingham, U.S. •University of Houston, U.S. •Zhongshan Ophthalmic Centre, Sun Yat-sen University, China •Holden BA, Mertz GW & McNally JJ. ‘Corneal swelling response to contact lenses worn under extended wear conditions’, Investigative Ophthalmology & Visual Science, February 1983. Brien Holden Vision Institute Capabilities and professional highlights 13 Current products and outlook for the future Extended depth of focus (EDOF) contact lenses Many commercial multifocal lenses claim to provide simultaneous vision at various visual distances but often this comes at the cost of reduced contrast, increased ghosting and compromised overall vision satisfaction. These shortcomings are often exacerbated with low illumination levels. Such visual compromises have been associated with an increase in patient dropout rate and lack of confidence in fitting by practitioners. Our EDOF contact lenses: 40 years of innovation 1998 SILICONE HYDROGEL CONTACT LENSES SILICONE HYDROGEL CONTACT LENSES, the class of contact lens materials that has captured over half of the $7 billion global contact lens market was co-invented by the Brien Holden Vision Institute as part of a CIBA Vision and Vision CRC collaboration. This class of materials now accounts for more than 50% of the soft contact lens market worldwide. •use higher order aberrations to optimise retinal image quality over a wide range of distances from far to near while eliminating ghosting and haloes •perform relatively independent of patients natural aberrations and variation in pupil size •are designed to meet the vision needs of emerging, moderate and advanced presbyopes. EDOF technology for presbyopia The Institute is currently developing a range of EDOF contact lenses, incorporating higher order aberrations, which are designed to provide optimal visual performance from distance to near with minimal ghosting. The range of EDOF designs aim to deliver a vision solution for all presbyopes including emerging, early, medium and mature presbyopes. EDOF technology for myopia control We did that 14 Brien Holden Vision Institute Capabilities and professional highlights The Institute has designed contact lenses using EDOF technology that influence retinal image quality and eye growth and thus myopia progression. The technology is being assessed in clinical trials. Innovation Dry eye drop We are developing a dry eye over-the-counter (OTC) drop that will protect against bacterial lipases and help maintain a healthy tear layer. This is the first such product on the market that directly targets the etiology of dry eye. The Institute believes this BHV-Artificial Tear product could revolutionise the dry eye/comfort drop market. Revolutionary treatment for presbyopia and cataract The Accommodating Gel project is developing a clear gel-lens system that will replace the old presbyopic or cataractous lens. The lens is removed during a simple procedure and replaced by the polymer gel. Existing ‘mechanical’ accommodating intraocular lenses have shown limited accommodative power – around 1.00 D to 1.50 D. In contrast, internal tests on an earlier gel prototype have shown accommodative amplitude comparable to the focusing ability of someone in their early 20s. Intelligent retinal imaging technology for detecting and diagnosing eye disease In development is the most advanced technology for use in real-time detection and assessment of common blinding eye disease and general health disorders. The Intelligent Retinal Camera will accurately and rapidly detect, and eventually diagnose, sight-threatening conditions such as diabetic retinopathy and glaucoma. The camera is being designed for ease of use in the most extreme environments so that it can be used by technical support staff and in the most remote and under-served locations. Neuro-ophthalmic device (NODe) Brien Holden Vision Diagnostics is developing a neuroophthalmic device that can measure pupillary response and eye movements to aid in the diagnosis of a broad range of disorders affecting the visual system. This exciting new product will likely have applications in the following areas: •ophthalmology to measure visual fields, vergence, phorias and tropias, saccadic movements and smooth pursuit movements •neurology to diagnose concussion, stroke, brain tumour, Alzheimer’s Disease, Parkinson’s Disease and some psychiatric disorders •long-term patient care to evaluate and track the impact of treatment. Brien Holden Vision Institute Capabilities and professional highlights 15 Clinical research Australia Brien Holden Vision Institute Sydney Our Clinical Research Trial Centre in Sydney is a specialised clinical research facility with capabilities and programs specifically designed to meet the needs of the ophthalmic and vision care industry. Dedicated clinical research teams aim to identify and understand clinical problems by evaluating the performance of contemporary products. We have the capacity, technical expertise and experience to generate effective product-based solutions. Extensive laboratory facilities and the expertise of the scientific team provide a vital adjunct by enabling in-depth evaluation of the interaction between products and the ocular environment. Clinical research activities are dedicated to developing and testing products for vision correction, including: •contact lenses •contact lens solutions •spectacles •new instruments and techniques. All optometrists are highly qualified, required to demonstrate concordance at regular intervals, and undergo regular training to maintain and enhance general and specialised optometric skills. Local and international regulations and guidelines met include: •National Statement on Ethical Conduct in Human Research •Access to Unapproved Therapeutic Goods •Good Clinical Practice •Declaration of Helsinki. 16 Brien Holden Vision Institute Capabilities and professional highlights Innovation We currently have almost 3000 active participants on our comprehensive register, with a range of ages and backgrounds, on the database of our Sydney facility. Brien Holden Vision Institute has clinical research centres in China and India and three overseas collaborators for trials that require special populations or a larger sample size. China Brien Holden Vision Institute Guangzhou India Brien Holden Vision Pvt. Ltd. Hyderabad Developing and coordinating clinical and marketing studies related to the use and performance of products in India and the region, such as: •intelligent retinal imaging system •myopia control products •products for presbyopia and other advanced technology Clinical trials facilities and expertise allowing for assessment of key factors associated with development and progression of refractive errors and other ocular conditions, product development and testing for vision correction, including: •innovative, sustainable vision care delivery systems and facilities. •contact lenses •One of the leading eye research, teaching and treatment hospitals in India •contact lens care solutions •spectacles •new optical instruments and techniques. Zhongshan Ophthalmic Centre at Sun Yat-sen University Guangzhou •The major provider of advanced eye care in China •integrating teaching, eye research and blindness prevention activities •treating nearly 500,000 outpatients and conducting 30,000 surgeries each year. LV Prasad Eye Institute (LVPEI) Hyderabad •World Health Organization Collaborating Centre for Prevention of Blindness •served over 18 million people since 1987 awarded 35 PhDs and published over 1550 research papers. South Africa African Vision Research Institute (AVRI) Durban Our partnership with AVRI enables access to the University of KwaZulu-Natal optometry discipline, and through this, the capacity to conduct clinical research and product evaluation. Brien Holden Vision Institute Capabilities and professional highlights 17 Technology – novel instruments and know how Improvements Instruments critical to understanding the performance of the eye and novel vision correction devices can be designed and custom-built by our in-house technology team, enhancing research possibilities. •Modified Autorefractor (2007) •Aberrometer (2009) •Measuring Microscope (2013) Comprising highly-skilled engineers, scientists, optometrists and technicians, the Technology team offers tremendous knowledge and skills related to vision science, optical design, software development and biometry and metrology system engineering, possessing services in the areas of: Biological sciences •contact lens metrology •developed and validated clinical assessment tools •material testing. Our novel instruments •Optical modelling and lens design (ongoing since 1980s) •Optical Quality Analyser (1985) •CRCERT-Belmonte Aesthesiometer (1998-2000) •Ex Vivo Accommodation Simulator (2002-2005) •Eye Tracker (2003-2004) •Micro-Tensometer (2003-2004) •Model Eye (2007-2011) •EyeMapper (2007-2011) •OCT Profilometer (2014) •Friction Meter (2015) Our Biological Sciences team undertakes research that enhances our understanding of ocular health and explores novel avenues of combating ocular diseases. These investigations are vital in predicting the ocular response to new and existing contact lens designs, as well as contact lens solutions and cases. Research and product development capabilities are in the core areas of microbiology, cell biology, biochemistry, molecular biology and immunobiology, including: •diagnostic microbiology •evaluation of antimicrobial efficacy of contact lens care products and hygiene practice •determination of efficacy of novel antimicrobials •cell culture facility •biochemical analysis of tears, meibum and contact lens deposits. Technology development highlight – modified pachometer Innovations in technology and instrumentation often pave the way to new scientific and industrial breakthroughs. The Institute recognises this and has, from its earliest history, maintained world-leading developments in metrology and biometry systems. For example, in 1979, we optimised the optical pachometer for high accuracy and direct data acquisition. Harnessing the capabilities provided by the early personal computers and enhancing the resolution by the coupling of precision potentiometer to the basic pachometer, the Institute’s pachometer provided the technology platform that enabled the first overnight corneal swelling studies to be conducted. These studies led to the definition of the minimum oxygen required to maintain a healthy cornea during overnight contact lens wear. Our discovery provided the target specifications that eventually saw the availability of the first silicone hydrogel contact lens and the accompanying silicone hydrogel revolution. 18 Brien Holden Vision Institute Capabilities and professional highlights Innovation Chemistry Medical device design and manufacture capability are provided through our entity, Brien Holden Vision Pty Ltd, with laboratory activities conducted as part of an EN ISO 13485 compliant quality management system. This includes: •qualification of components in formulations: •polymer synthesis capability •qualification of components: •polymer characterisation, inclusive of in-house gel permeation chromatography (GPC) and rheology - materials specification - raw materials identification and procurement - shelf life testing - reagent compatibility. Brien Holden Vision Institute Capabilities and professional highlights 19 Technology highlights Optical quality analyzer Model eye Invaluable assessment of contact lens quality, optical design, and defects not possible with conventional tools Assessing eye-lens design interactions to achieve optimal lens performance Brien Holden Vision Institute has been investigating the design and performance of bifocal contact lenses since the late 1970s. In the early years, some aspects of the geometry of even relatively simple designs such as centre-near bifocals could not be quantified. The first optical quality analyser (OQA), also called Zonometer, was developed in 1983 to meet this need. Through successive generations of improvements, the OQA has evolved into an invaluable system for the assessment of the quality of contact lenses as well as a tool for the rapid identification of optical design features and optical defects not detectable using conventional instrumentation. While computer-assisted optical modelling and design can go a long way in facilitating the development of new vision correction systems, there are factors specific to contact lenses, such as the optical effect of the tear layer, that cannot be readily predicted on paper. The Brien Holden Vision Institute Model Eye was developed between 2007—2010 to provide a physical model for evaluating the performance of new designs. It overcomes the limitations of computer-models, but without incurring the variability often experienced in clinical studies. This Model Eye is capable of assessing peripheral as well as central optical performance. Eye mapper An important tool in controlling myopia progression One of the hypotheses Brien Holden Vision Institute has been testing, to aid in developing optical interventions that can reduce the progression of myopia in children, is that peripheral refraction can modulate eye growth. Beginning in 2007, working in close collaboration with Professor Earl Smith, University of Houston, a world-leader in myopia research, we have developed spectacles and contact lenses with optical designs that have demonstrated efficacy in reducing myopia progression. In order to refine and optimise this strategy, the peripheral refractive state of individual eyes need to be known precisely. The Eye Mapper has been developed as a method for rapidly assessing the refractive state across the visual field of an eye. Manufacturing transfer and quality assurance Closing the R&D loop In addition to the optical design expertise, a range of software tools has been developed to optimise all other design features for toric, multifocal and single vision contact lenses. Mathematical descriptions of complete front and back surface shapes can be translated into machine readable code for the various production platforms and lens materials. Sophisticated metrology closes the loop to ensure that lenses are manufactured to specifications, applying correction factors to the design files if required to compensate for any deviations. Licensing Brien Holden Vision Institute has two pathways for translating our research into products and solutions – through licensing our intellectual property and through the activities of our commercial entities. Intellectual property (IP) management The IP portfolio of the institute (patents, trademarks and domain names) is managed by an in-house team (IP Counsel, IP Manager and an IP coordinator). The team actively oversee and manage the prosecution, registration and maintenance of the IP portfolio in consultation with external IP and trademark attorneys and registries. In addition, the IP team also supports the needs, as required, by the stakeholders of the Institute, involving inventors, project and legal teams, board, senior management, collaborators and industry partners. Commercialisation In 2013, we launched Brien Holden Vision, a group of commercial entities of the Brien Holden Vision Institute, to develop our own pathways for advanced and beneficial products and services for those in need of vision correction and to detect signs of conditions that threaten vision, eye and general health and to generate resources for our mission. 22 Brien Holden Vision Institute Capabilities and professional highlights Licensing These are: Adventus Technology Inc. (ATI) •Brien Holden Vision Innovation Pte Ltd, Singapore Owned by the Brien Holden Vision Institute and Vision CRC participants, ATI, a U.S. corporation, is working on a revolutionary polymer gel to provide full visual rehabilitation to presbyopia and cataract patients, restoring distance and near focusing ability similar to that of a young eye. •Brien Holden Vision Diagnostics Inc., U.S. •Brien Holden Vision Care Inc., U.S. •Brien Holden Vision Innovation Inc., U.S. •Brien Holden Vision Pty Ltd, Australia •Brien Holden Vision Pvt Ltd, India These products and services fall into the following strategic approaches: 1.Vision care products – such as contact lenses and lens care solutions that improve health and vision, control myopia and correct presbyopia. 2.Enabling technology – technology and/or products that detect eye and health problems to deliver better health and vision care at affordable cost. 3.Social entrepreneurship – innovative, sustainable vision care delivery systems and facilities based on bestpractice affordable vision care. Bioptigen Inc. As a pioneer in the development and manufacture of leading edge Spectral Domain Optical Coherence Tomography (SDOCT) equipment and software, Bioptigen is helping researchers open windows into the wonders of ocular development and the mysteries of ocular disease. In 2011, Brien Holden Vision Institute, Adventus Technology Inc. and Bioptigen Inc., teamed up to create a state-ofthe-art intra-operative imaging device that provides a new standard of real time ophthalmic imaging. Adventus Technology Inc. has licenced its intraoperative OCT patent to Bioptigen Inc., and Brien Holden Vision Pty Ltd is representing Bioptigen through demonstrating, sales and service support of their OCT system to Australian clients. Strategic partnerships By establishing Brien Holden Vision entities in many countries and through collaborations with industry, practitioners, optometry schools, professional bodies and governments, we have created a network of connections with the capacity to build awareness, conduct education around, and promote the distribution of, new ophthalmic and optical products. Investments The Institute has invested in two commercial companies focused on the areas of surgical solutions for presbyopia and cataract, and on advanced optical imaging technologies. Brien Holden Vision Institute Capabilities and professional highlights 23 Education Human resource development Professional education programs Brien Holden Vision Institute has extensive history in practitioner and educator education, in developed markets, particularly in the area of spectacle and contact lenses, including: •professional contact lens and spectacle lens education programs to over 82,000 practitioners and students globally •education and promotion around breakthrough contact lens material •continued participation and involvement in key international conferences and symposia •postgraduate research education Major contact lens programs •International Association of Contact Lens Educators (IACLE) – education programs now exist in over 60 countries •Asia Pacific Contact Lens Education Programme (APCLEP) – over 15,000 practitioners trained since 1990 •Indian Contact Lens Education Programme (ICLEP) – almost 5000 practitioners trained since 1990. Other programs •Global Contact Lens Education Program (GCLEP) •Middle East Contact Lens Education Program (MCLEP) •Gas Permeable Contact Lens Education Program (GPCLEP) •Growing the Australian Contact Lens Market program (GACLM) •Collaboration with Essilor – growing the progressive lens market. 24 Brien Holden Vision Institute Capabilities and professional highlights Education Professional development programs with Essilor Brien Holden Vision Institute (formerly the International Centre for Eyecare Education) has conducted professional education programs with Essilor for over 17 years, including: •Varilux Academy Asia Pacific (VAAP) program – 8000 practitioners, with almost 40,000 educated by presenters trained •Varilux Academy Initiative (VAEI) – implemented in 70 universities and colleges across the AMERA region – 1350 educators and 1900 students trained. Promotion of a breakthrough contact lens material As a co-inventor with CIBA VISION (now Alcon) of the first silicone hydrogel contact lens, the Institute was at the forefront of efforts to promote and gain acceptance of the benefits of this new material, estimated in 2013 to account for around 50% of all new contact lens fits.27 These activities included: •Silicone Hydrogels website – the major source of information about these new lenses for practitioners and researchers •symposia hosted in several countries •sessions for practitioners held throughout Australia •presentations at major international conferences for over a decade •extensive peer-reviewed publications •conducted the first clinical trials that generated much of the efficacy data and a site for FDA trials conducted to gain regulatory approval •clinical information based on above studies were published by the Institute, which was used in marketing by CIBA VISION. Highlight education program – EyeTeach© Globally, eye care practitioner numbers are low, with a deficit in training institutes a major factor. EyeTeach© is a series of programs targeting optometry school development and equipping educators with teaching skills. The program encompasses best practice for learning and teaching, clinical skills teaching and integrating research within the optometry program/faculty. Initiated in 2011, EyeTeach© has trained over 700 educators from: Bolivia, Cameroon, China, Colombia, Ethiopia, Fiji, Guyana, India, Kenya, Lebanon, Malawi, Mali, Mozambique, Pakistan, Papua New Guinea, Peru, South Africa, Tanzania, Thailand, Trinidad & Tobago and Vietnam. Postgraduate research education The Institute offers postgraduate research opportunities in Australia and through our associated organisations in South Africa, China and India, including; •African Vision Research Institute, Durban, South Africa •India Vision Institute, Hyderabad, India •LV Prasad Eye Institute, Hyderabad, India •Zhongshan Ophthalmic Centre, Guangzhou, China. We have educated 185 PhD and MSc students. Brien Holden Vision Institute Capabilities and professional highlights 25 Brien Holden Vision Institute Academy Education is key to our strategies to deliver quality eye care to the 625 million people globally with uncorrected refractive error. The Institute has developed the expertise to set up relevant educational programs including optometry schools, as well as a range of courses to teach competencies from the community level upward, offering professional development of personnel and further career opportunities. These initiatives and programs include offering education courses in clinical, pedagogical, research and business areas and developing teaching and learning tools and resources. This includes: •online resources •primary eye care education •refraction •technical and optometric education •vision centre management •faculty development •professional education •improve optometry standards. Education resources Global Optometry Resources website One of the challenges for emerging optometry schools is limited access to teaching and learning resources. The Institute’s Global Optometry Resources website offers free optometry modules that comprise the backbone of an optometry curriculum that educators and students can utilise. Including PowerPoint presentations and course notes, these materials are available in four different languages – English, French, Spanish and Portuguese. 26 Brien Holden Vision Institute Capabilities and professional highlights Education Other resources Interactive student materials Additionally, a series of downloadable resources for other levels of eye care education are available, including: In development are materials for student self-learning which also allow for setting assessment protocols to measure student progress. These include: •Primary Eye Care Manual •Refraction Manual •Virtual Refractor •Vision Centre Toolkit •interactive learning activities •Basic Refraction for Ophthalmologists. •Student Refraction Manual. Highlight education resource – Virtual Refractor The Virtual Refractor is a web-based learning tool that: •simulates a distance subjective refraction using a refractor head •provides virtual patients with numerous demographic profiles who respond to various test charts and questions regarding the effects of lens combinations •allows optometry students to gain a strong working knowledge of how to perform a refraction prior to practical clinical sessions •a useful teaching and assessment tool for optometry educators. Brien Holden Vision Institute Capabilities and professional highlights 27 Public health Sustainable service development 28 Brien Holden Vision Institute Capabilities and professional highlights Public health More than 625 million people are unnecessarily blind or vision impaired due to refractive error, simply because they don’t have access to an eye examination and a pair of glasses. As both leader and collaborator, Brien Holden Vision Institute advances vision care on the global public health agenda and builds sustainable, culturally appropriate systems for vision care in local communities. In addition to our education and human resource activities, we achieve this through the following approaches: Child eye health Children in all regions of the world are affected by a range of eye diseases and conditions. We believe in order to be effective and sustainable, child eye health programs must be integrated within the national and provincial health systems, and also within existing school health services. It is essential that child eye health services are linked with extended education and social development systems. Brien Holden Vision Institute believes it is important that children are not simply the beneficiaries of eye health activities, but important links in the process of care. To achieve greater success it is essential to involve children in health implementation activities; promotion aimed at family members, neighbours, their peers, and communities. Vision centre and outreach We recognise the importance of building sustainable eye care systems in collaboration with national and regional health systems to ensure we meet community needs. The Institute’s strategies are based on establishing environments that enable trained eye care professionals to provide clinical and refractive services. Social enterprise Social Enterprise is about maximising human well-being, taking the power of the market place to solve some of the most pressing issues in society. The Institute is using social enterprise philosophies to help answer eye care provision challenges. Local people are being skilled in an eye care profession, working actively in their community and breaking free from the poverty cycle. This sustainable and self-generated income enables a better quality of life for people and, their families, while providing much needed services in their communities. Spectacle supply The Global Resource Centre, was initiated to sustainably supply affordable spectacle frames, lenses, readymade readers, low vision aids and eye care equipment to the global population. The availability of eye care service delivery infrastructure by itself does not guarantee access to spectacles because of the lack of availability or prohibitive costs, particularly in developing countries. Through being actively involved in the supply chain at multiple levels, the Global Resource Centre circumvents much of the compounding effect of price mark-ups, which normally drives product prices upwards. Complementing this with a bulk buying, bulk discount and a pricing strategy driven from a social mission, as opposed to a profit perspective, enables the Global Resource Centre to keep the products affordable. We develop new solutions for vision care to get services to places in need so everyone, regardless of their location, gender, culture or economic situation, can have access the same kind of care. Outreach programs are coordinated with other Institute activities to ensure eye care services are delivered and managed by local personnel, supported by local health systems, and are therefore sustainable. Brien Holden Vision Institute Capabilities and professional highlights 29 Vital Statistics - Global 2,742,599 474,517 4451 139,309 9 Total eye examination Total spectacles dispensed Total low vision devices dispensed Personnel trained Schools of optometry 369 Optometry students 124 Optometry graduates 814,963 Total children’s vision checked Impact on vision care worldwide Since 1991 we have: provided optometric services and glasses to 3.2 million people trained at different levels of eye care 139,000 people 430 vision centres or sites for eye care worked in over 50 countries established offices in Australia, China, Cambodia, Colombia, India, Malawi, Nigeria, Pakistan, Papua New Guinea, South Africa, Sri Lanka, Tanzania, Uganda, Vietnam. Vision Centre development 285 Vision centre toolkit downloads 429 Eye care clinics established 114,500 Direct beneficiaries 766,320 Indirect beneficiaries Practitioners & students communities the “refractionists” serve Refraction 1160 1,160,000 7,797,637 Downloads of refraction manual Direct beneficiaries academics, practitioners & students Indirect beneficiaries communities the “refractionists” serve Postgraduate education 185 30 Postgraduate research students educated Working in industry Global reach MOLDOVA UNITED STATES MALI HAITI GAMBIA COLOMBIA GHANA NIGERIA PERU CAMEROON BOLIVIA CHILE ARGENTINA WHERE WE OPERATE Brien Holden Vision Institute Main offices Sydney, Australia (Head Office) Durban, South Africa Guangzhou, China Brien Holden Vision Institute Regional offices Bogota, Colombia Hanoi, Vietnam Islamabad, Pakistan IVI, Hyderabad, India OPTOMETRY SCHOOL DEVELOPMENT Cameroon Yaoude School of Nursing Eritrea Asmara College of Health Sciences Kenya Masinde Muliro University Malawi •Mzuzu University •Malawi College of Health Sciences Mali Institut d’Ophtalmologie Tropicale de l’Afrique Mozambique University Lurio Vietnam Pham Ngoc Thach University of Medicine MONGOLIA CHINA BANGLADESH VIETNAM ERITREA INDIA ETHIOPIA UGANDA SRI LANKA KENYA TANZANIA PAKISTAN CAMBODIA SINGAPORE PAPUA NEW GUINEA SAMOA MALAWI AUSTRALIA MOZAMBIQUE FIJI SOUTH AFRICA EYE CARE SITES Cambodia Eritrea Ghana Kenya Mozambique Nigeria Pakistan Papua New Guinea South Africa Sri Lanka Tanzania Uganda Vietnam *400+ eye care sites established *120 low vision clinics serviced COMMERCIAL ENTITIES INVESTMENTS Brien Holden Vision Innovation Pte Ltd, Singapore Adventus Technology Inc., U.S. Brien Holden Vision Diagnostics Inc., U.S. Bioptigen Inc., U.S. Brien Holden Vision Care Inc., U.S. Brien Holden Vision Innovation Inc., U.S Brien Holden Vision Pty Ltd, Australia Brien Holden Vision Pvt Ltd, India Accreditation and Accountability Brien Holden Vision Institute is an accredited Independent Research Institute with the National Health and Medical Research Council (NHMRC) of Australia and a member of the Association of Australian Medical Research Institutes (AAMRI). Our microbiology laboratory is Physical Containment Level 2 (PC2) certified by the Gene Technology Regulator – enabling genetically modified organisms (GMOs) to be cultured or grown in controlled temperature conditions. Brien Holden Vision Institute, Public Health is an Australian Government accredited non-governmental organisation (NGO). The Institute is a partner in the Vision 2020 Australia Global Consortium, which administers the Australian Government’s Avoidable Blindness Initiative in Asia-Pacific. It is a member of the Australian Council for International Development (ACFID), the peak body for Australian international development NGOs, and adheres to the self-regulatory Code of Conduct mandated by ACFID. Brien Holden Vision Pty Ltd – located in Sydney, Australia, holds a multi-site EN ISO 13485 quality system registration for the design, manufacture and distribution of ophthalmic medical devices and solutions. 34 Brien Holden Vision Institute Capabilities and professional highlights References 1. Holden, B. A., Fricke, T. R., Wilson, D. A., Jong, M., Naidoo, K. S., Sankaridurg, P., Frick, K. D. & Resnikoff, S. 2014. Prevalence of myopia and high myopia now, in 2030 and 2050 (in preparation). 2. Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet 2012;379:1739-48. 3. Vitale S, Sperduto RD, Ferris FL, 3rd. Increased prevalence of myopia in the United States between 1971-1972 and 1999- 2004. Archives of ophthalmology 2009;127:1632-9. 4. Younan C, Mitchell P, Cumming RG, Rochtchina E, Wang JJ. Myopia and incident cataract and cataract surgery: The Blue Mountains eye study. Investigative ophthalmology & visual science 2002;43:3625-32. 5. Mitchell P, Hourihan F, Sandbach J, Wang JJ. The relationship between glaucoma and myopia: the Blue Mountains Eye Study. Ophthalmology 1999;106:2010-5. 6. Group TEDC-CS. Risk factors for idiopathic rhegmatogenous retinal detachment. The Eye Disease Case-Control Study Group. American journal of epidemiology 1993;137:749-57. 7. Wu L, Sun X, Zhou X, Weng C. Causes and 3-year-incidence of blindness in Jing-An District, Shanghai, China 2001-2009. BMC ophthalmology 2011;11:10. 8. Iwase A, Araie M, Tomidokoro A, et al. Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi Study. Ophthalmology 2006;113:1354-62. 9. Wong TY, Ferreira A, Hughes R, Carter G, Mitchell P. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence-based systematic review. American journal of ophthalmology 2014;157:9-25 e12. 10.Holden BA, Fricke TR, May Ho S, Wong R, Schlenther G, Cronje S, Burnett A, Papas E, Naidoo KS, Frick KD, ‘Global vision impairment due to uncorrected presbyopia’, Archives of Ophthalmology, Vol 126 (No. 12), Dec 2008. 11.Tahhan, N., Papas, E., Fricke, T. R., Frick, K. D. & Holden, B. A. 2013. Utility and uncorrected refractive error. Ophthalmology, 120, 1736-44. 12.Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, et al. National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants. The Lancet. 378(9785):31-40. 13.International Diabetes Federation: http://www.idf.org/ diabetesatlas/5e/the-global-burden 14.Joy J et al. A review on diabetic retinopathy, International Journal of Pharmacology Research, 1(1), 2011, 1. 15.Zheng Y, He M, Congdon N. The worldwide epidemic of diabetic retinopathy. Indian J Ophthalmol, 2012;60:428 16.International Dry Eye WorkShop Subcommittee, 2007, ‘The epidemiology of dry eye disease: Report of the epidemiology subcommittee of the International Dry Eye WorkShop (2007), accessed at: http://www.tearfilm.org/dewsreport/pdfs/The%20 Epidemiology%20of%20Dry%20Eye%20Disease.pdf 17. Global Industry Analysts, 2012, Artificial tears – A global strategic business report. 18.Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, et al. Causes of vision loss worldwide, 1990-2010: a systematic analysis. The Lancet Global Health [Internet]. 2013 13 November 2013. Available from: http://www.thelancet.com/ journals/langlo/ article/PIIS2214-109X(13)70113-X/fulltext 19.Smith TS, Frick KD, Holden BA, Fricke TR, Naidoo KS. Potential lost productivity resulting from the global burden of uncorrected refractive error. Bulletin of the World Health Organization 2009;87:431-7. 20.Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S & Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bulletin of the World Health Organization, 2012;90:728-738. 21.World Health Organization, Visual impairment and blindness Fact Sheet N°282 Updated August 2014, accessed at: http://www. who.int/mediacentre/factsheets/fs282/en/ 22.World Health Organisation (2000) Preventing blindness in children. Report of a WHO/ IAPB scientific meeting. Geneva: WHO. (WHO/ PBL/00.77). 23.Dumbleton K, Woods CA, Jones LW & Fonn D, The impact of contemporary contact lenses on contact lens discontinuation, Eye and Contact Lens, 2013, 39, 93-99. 24.Brien Holden Vision Institute estimates, 2014. 25.Vision Impact Institute. The social and economic impact of poor vision. Paris, France: 2012. 26.Sankaridurg P, Donovan L, Varnas S, Ho A, Chen X, Martinez A, Fisher S, Lin Z, Smith EL, Ge J, Holden B. ‘Spectacle Lenses Designed to Reduce Progression of Myopia: 12-Month Results’, Optometry & Vision Science. 87(9):631-641, September 2010. 27. Contact Lens Spectrum, 2014, International Contact Lens Prescribing in 2013 http://www.clspectrum.com/articleviewer. aspx?articleID=109321 Brien Holden Vision Institute Capabilities and professional highlights 35 ® Global Head Office Level 4 North Wing, Rupert Myers Building Gate 14 Barker Street, University of New South Wales Sydney NSW 2052 AUSTRALIA Tel: +61 2 9385 7516 Find out more at: brienholdenvision.org For more about products: brienholdenvision.com ™ BrienHolden HoldenVision VisionInstitute Institute Capabilities Capabilitiesand andprofessional professionalhighlights highlights 36 Brien