Download ophthalmology Futures 2012

o ph th a l m o l o gy F u tu r e s
2012
E u r o p ean F ORUM
C a t a r a c t , G l a u c o ma a nd R e fr a c t iv e S u rg ery
Bringing together ophthalmic innovation, financial expertise
and corporate leadership
6th September 2012
Hotel Principe di Savoia, Milan, Italy
PROGRAMME
o phthal m o l o gy F u tu r es
2 0 1 2 European f o r u m
Dear participants
Welcome to the Ophthalmology Futures 2012 - European Forum. We look forward
to a highly stimulating, interactive and informative meeting.
Our inaugural European Forum will focus on cataract and intraocular lens
technology, refractive surgery, pharmaceuticals and glaucoma devices. Our aim is
to present a programme that facilitates discussion between professionals involved
in improving ocular health, and present an exclusive environment for business
conversation.
We hope that the panel sessions led by our eminent faculty, who will discuss
the opportunities and challenges of developing drugs and devices in Europe,
will motivate you to participate actively. We encourage questions from the floor.
In addition, we hope that you will enjoy and gain inspiration from the company
presentations which highlight the breadth of innovation which is occurring in the
field of ophthalmology.
We would like to thank our advisory panel, sponsors and contributors for their
invaluable support and assistance.
We also look forward to your participation in next year’s Ophthalmology Futures
2013 European Forum, which will be in Amsterdam.
Transforming Lives Through Better Vision
As the global leader in eye care, Alcon is committed to helping enhance the quality of life
by helping people see better. We offer the widest spectrum of surgical, pharmaceutical and
vision care products in the industry. Our 24,000 associates partner with eye care professionals
to take on the world’s most pressing eye care needs and deliver innovations that reinvent
lives. The future of eye care starts with Alcon.
Keith Barton
Kuldev Singh
www.alcon.com
© 2012 Novartis
Vision Futures Limited, London, UK, registered in England No: 8125858
o p ht ha l m o l o gy F u t ure s
T IME
201 2 E u r o p e a n for um
TOPI C
TIME
TOPIC
12:00-12:05Introduction
Keith Barton
Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Kuldev Singh
Professor of Ophthalmology, Director Glaucoma Service, Stanford
University, Stanford, USA
Stefano Miglior
Head of the Department of Ophthalmology, Policlinico di Monza,
University of Milan Bicocca, Italy
Gabor Scharioth
Senior Consultant, Aurelios Augenzentrum, Recklinghausen, Germany
14:10-14:40
Company presentations: Corneal and Refractive Surgery
12:05-12:50 The Ophthalmic Sector from a European Perspective
Chair Chair
John Marshall
Frost Professor of Ophthalmology, Institute of Ophthalmology,
University College, Moorfields Eye Hospital, London, UK
AcuFocus
Presenters Corina van de Pol
Chief Clinical Officer, AcuFocus, USA
Panellists
Thomas Kohnen
Professor of Ophthalmology, Goethe University, Frankfurt, Germany
James Mazzo
President, Abbott Medical Optics, Senior VP, Abbott Laboratories, USA
Paul Rosen
Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford, UK
Baldo Scassellati Sforzolini
VP Global Drug Development, Bausch + Lomb, USA
12:50-13:40 Company presentations: Glaucoma Devices
Chair
Keith Barton
Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Implandata Ophthalmic Products
Presenters Max Ostermeier
Founder and CEO, Implandata Ophthalmic Products, Germany
InnFocus
Len Pinchuk
President and CEO, InnFocus, USA
EyeTechCare
Fabrice Romano CEO, EyeTechCare, France
Mark Perry
International Sales Director, EyeTechCare, France
Aquesys
Chris Horvath
VP, Research & Development, Aquesys, USA
Ivantis
Dave Van Meter
President and CEO, Ivantis, USA
Transcend Medical
Brian Walsh
President and CEO, Transcend Medical, USA
13:40-14:10
Glaucoma Surgical Innovation: The Present and the Future
Chair
Kuldev Singh
Professor of Ophthalmology, Director Glaucoma Service, Stanford
University, Stanford, USA
Panellists
Stefano Gandolfi
Professor, Ophthalmology Clinic, University of Parma, Italy
Greg Kunst
Global Product Director, Surgical Glaucoma, Alcon, USA
Marco Nardi
Professor in Ophthalmology and Director, Ophthalmology
Department, University of Pisa, Italy
Julian Stevens
Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK
Refocus Ocular Europe
Doug Williamson
President and CEO, Refocus Ocular Europe, The Netherlands
ReVision Optics
John Kilcoyne
President and CEO, ReVision Optics, USA
14:40-15:10
Has Refractive Surgery Peaked or is the Best yet to Come?
Chair
Sheraz Daya
Chairman and Medical Director, Centre for Sight. Faculty, University
Hospital, Brest, France
Panellists
Gerd Auffarth
Consultant, International Vision Correction Research Centre (IVCRC),
University of Heidelberg, Germany
Michael Knorz
Medical Director, CEO, FreeVis LASIK Group, Mannheim, Germany
AIoannis G. Pallikaris
Professor in Ophthalmology, School of Medicine, University of Crete,
Heraklion, Crete, Greece
Julian Stevens
Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK
15:10-15:30
Networking Break
15:30-16:05 Company presentations: Cataract and IOL Technology
Chairs
David Spalton
Consultant Ophthalmologist, King Edward VII Hospital, London, UK
Richard Packard
Senior Consultant, Prince Charles Eye Unit, Windsor, UK
AkkoLens International
Presenters Michiel C. Rombach
CEO, AkkoLens International, The Netherlands
Anew Optics
Anna S. Hayes
CEO, Anew Optics, USA
Aurolab
Ravilla Duraisami Sriram
Director Operations, Aurolab, India
Technolas-Perfect Vision
Freider Loesel
Chief Strategy Officer, Technolas-Perfect Vision, Germany
o p ht ha l m o l o gy F u t ure s
T IME
201 2 E u r o p e a n for um
TOPI C
TIME
16:05-16:30 Who Will Pay? Cataract Innovation and Reimbursement Challenges
Chair
Paul Rosen
Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford, UK
Panellists
Rafael Chan Director, Global IOL Marketing, Alcon, USA
Beatrice Cochener
Professor, Chairman, Ophthalmology Department, University Hospital,
Brest. President, French Academy of Ophthalmology, France
Sheraz Daya
Chairman and Medical Director, Centre for Sight. Faculty, University Hospital, Brest, France Ferderic Ernst
Director Market Access Europe, Santen, Germany
Boris Malyugin
Professor of Ophthalmology, Deputy Director General (R&D, Ed)
S. Fyodorov Eye Microsurgery State Institution, Russia
Andy Stapars
Director, Reimbursement and Market Access, Abbott Medical Optics, USA
Kaarina Vannas
Hospital Mehiläinen, University Eye Hospital, Helsinki Private Eye
Hospital, Helsinki, Finland
16:30-17:05
Company presentations: Ophthalmic Pharmaceuticals
Chair
Stefano Miglior
Head of the Department of Ophthalmology, Policlinico di Monza,
University of Milan Bicocca, Italy
Alimera Sciences
Presenters Dan Myers
President and CEO, Alimera Sciences, USA
Amakem Therapeutics
Jack Elands
CEO, Amakem Therapeutics, Belgium
Icon Bioscience
W. Sandy White
CEO, Icon Bioscience, USA
Ocular Therapeutix
Scott Corning
VP Sales and Marketing, Ocular Therapeutix, USA
17:05-17:30
Ophthalmic Pharmaceutical Innovation in a Competitive World
Chair
Carlo E. Traverso
Professor and Chairman, Clinica Oculistica Di.N.O.G.M.I., University of
Genoa, Italy
Panellists
Jorge Alio
Section Head, Institution Ophthalmology of Alicante, Vissum, Spain
Anders Behndig
Professor, Department of Clinical Sciences/Ophthalmology, Umeå
University Hospital, Umeå, Sweden
Gabor Hollo
Professor of Ophthalmology, Semmelweis University, Budapest, Hungary
Schalon Newton
VP, Strategic Marketing and Business Development, Santen, USA
TOPIC
17:30-18:00
Ingeborg Stalmans
Head of the Glaucoma Unit, Ophthalmology Department, University
Hospitals, Leuven, Belgium
The Regulatory Environment in Europe versus North America
Chair
James Mazzo
President, Abbott Medical Optics, Senior VP, Abbott Laboratories, USA
Panellists
Steve Pakola
Chief Medical Officer, Amakem Therapeutics, Belgium
Sharon Tonetta
VP of Global Regulatory Affairs and New Product Development,
Bausch + Lomb, USA
18:00-18:20 Networking Break
18:20-19:00 Trials, Tribulations and Pearls for Funding Private Ophthalmic Companies
Chair
John Marshall
Frost Professor of Ophthalmology, Institute of Ophthalmology,
University College, Moorfields Eye Hospital, London, UK
Matteo Piovella
President of the Italian Ophthalmological Society (SOI). Founder and
Medical Director of Centro Microchirurgia Ambulatoriale, Monza, Italy
Panellists Michael Mrochen Founder and CEO, IROC Science to Innovation, Switzerland
Samir Patel
President and CEO, Ophthotech, USA
Ed Peterson
President and CEO, AcuFocus, US
Jean-Marc Wismer
CEO, Sensimed, Switzerland
19:00-19:25 Beyond the Hype: What Big Companies Really Look for in Acquisitions
Chair
Julian Stevens
Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK
Panellists
Leonard Borrmann
Divisional VP, Research & Development, Abbott Medical Optics, USA
Johanna Knospe
VP Business Development & Product Planning Europe, Santen, Germany
Dario Paggiarino
VP of Retina Development, Alcon, USA
Baldo Scassellati Sforzolini
VP Global Drug Development, Bausch + Lomb, USA
19:25-19:30 Closing Comments Keith Barton
Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Cocktail
Reception
Kuldev Singh
Professor of Ophthalmology, Director Glaucoma Service, Stanford
University, Stanford, USA
19:30-20:30
Yellox... putting a stop
†
to ocular inflammation
fewer drops. less time.*
o phthalmology F utures
2012
E ur o pe a n f o r um
PROGRAMME SPONSORS
PLATINUM
Yellox delivers rapid penetration and powerful resolution of ocular
inflammation in less time, with highly potent and targeted prostaglandin
inhibition in fewer drops, allowing unique twice daily dosing.*
Fast‡1-3
Powerful1
Convenient1,4
Well-tolerated§1,4
GOLD
Yellox – a new standard in ocular NSAID efficacy
Yellox® (bromfenac sodium sesquihydrate) 0.9 mg/ml eye drops, solution. Prescribing
Information. Please refer to the Summary of Product Characteristics before prescribing Yellox®.
Pharmaceutical form: Eye drops containing 0.9 mg/ml bromfenac (as sodium sesquihydrate) in
clear yellow solution; one drop contains approximately 33 micrograms bromfenac. Indication:
Treatment of postoperative ocular inflammation following cataract extraction in adults. Dosage
and administration: For ocular use. Use in adults, including the elderly: The dose is one drop of
Yellox in the affected eye(s) twice daily, beginning the day after cataract surgery and continuing
through the first 2 postoperative weeks. The treatment should not exceed 2 weeks as safety data
beyond this is not available. Paediatric population: Safety and efficacy in paediatric patients have
not been established. Hepatic or renal impairment: Safety and efficacy have not been established
in patients with hepatic disease or renal impairment. Contraindications: Known hypersensitivity
to bromfenac, any of the excipients, or other non-steroidal anti-inflammatory medicinal products
(NSAIDs). History of asthma, urticaria or acute rhinitis precipitated by acetylsalicylic acid or by
other medicinal products with prostaglandin synthetase inhibiting activity. Special warnings and
precautions: Topical NSAIDs and corticosteroids may both slow or delay healing; their
concomitant use may increase this potential. Yellox contains sodium sulphite, which may cause
allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe
asthmatic episodes in susceptible patients. Cross-sensitivity: There is the potential for crosssensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, so caution is
required among patients with a history of sensitivities to these medicinal products. Susceptible
persons: In susceptible patients, continued use of topical NSAIDs, including Yellox, may result in
potentially sight-threatening complications (epithelial breakdown, corneal thinning, corneal
erosion, corneal ulceration or corneal perforation). Patients with evidence of corneal epithelial
breakdown should immediately discontinue use of topical NSAIDs and be closely monitored. In
at-risk patients, concomitant use of ophthalmic corticosteroids with NSAIDs may increase risk of
corneal adverse events. Postmarketing experience with NSAIDs: Patients with complicated ocular
surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and ocular surface
diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short
period of time may be at increased risk for corneal adverse reactions. Topical NSAIDs should be
used with caution in these patients. There have been reports that ophthalmic NSAIDs may cause
increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery.
Yellox should therefore be used with caution in patients with known bleeding tendencies or who
are receiving other medicinal products that may prolong bleeding time. Ocular infection: An
acute ocular infection may be masked by the topical use of anti-inflammatory medicinal
products. Excipients: Since Yellox contains benzalkonium chloride, close monitoring is required
with frequent or prolonged use. Benzalkonium chloride is known to discolour soft contact lenses,
and has been reported to cause eye irritation, punctuate keratopathy and/or toxic ulcerative
keratopathy. Special instructions regarding drop instillation: Multiple topical ophthalmic
medicinal products should be administered at least 5 minutes apart. Avoid contaminating the
dropper-tip and solution, and tightly close the bottle when not in use. Contact lenses should not
be worn during treatment with Yellox. Interactions: Formal interaction studies have not been
performed, but no interactions with antibiotic eye drops used in conjunction with surgery have
been reported. Fertility, pregnancy and lactation: Pregnancy: There are no adequate data from
the use of bromfenac in pregnant women, and the potential risk for humans is unknown. In
general, the use of Yellox is not recommended during pregnancy unless the benefit outweighs the
potential risk. Breast-feeding: It is unknown whether bromfenac or its metabolites are excreted in
human milk. The use of Yellox is in general not recommended during breastfeeding unless the
benefit outweighs the potential risk. Fertility: No pregnancy testing or contraceptive measures are
required. Effects on ability to drive and use machinery: Transient blurring of vision may occur
on instillation. If blurred vision occurs at instillation refrain from driving or using machines until
vision is clear. Undesirable effects: In clinical trials (n = 973), a total of 3.4% of patients had ≥1
adverse reactions. The most common or most important reactions were abnormal sensation in
eye (0.5%), corneal erosion (mild or moderate, 0.4%), eye pruritus (0.4%), eye pain (0.3%) and
eye redness (0.3%). Summary of adverse reactions: Uncommon (≥0.1% to <1%): reduced visual
acuity, haemorrhagic retinopathy, corneal epithelium defect (reported with QID use, off-label use,
QID), corneal erosion (mild or moderate), corneal epithelium disorder, corneal oedema, retinal
exudates, eye pain, eyelid bleeding, vision blurred, photophobia , eyelid oedema, eye
discharge, eye pruritus, eye irritation, eye redness, conjunctival hyperaemia, abnormal sensation
in eye, ocular discomfort, epistaxis, cough, nasal sinus drainage and face swelling. Rare (≥0.01%
to <0.1%; isolated reports from post-marketing experience of more than 20 million patients):
corneal perforation, corneal ulcer, corneal erosion – serious, scleromalacia, corneal infiltrates,
corneal disorder, corneal scar and asthma. Please consult the Summary of Product Characteristics
for a full list of side effects. Overdose: If Yellox is accidentally ingested, fluids should be taken to
dilute the medicinal product. Pharmaceutical precautions: Do not store above 25°C. Legal
Category: POM. Marketing Authorisation Number: EU/1/11/692/001. Marketing
Authorisation Holder: Croma Pharma GmbH, Industriezeile 6, A-2100 Leobendorf, Austria.
Date of preparation: April 2011.
Adverse events should be reported. Reporting forms and
information can be found at www.yellowcard.gov.uk. Adverse
events should also be reported to Bausch & Lomb UK Ltd on
01748 828864.
References
1. Yellox, Summary of Product Characteristics
2. Donnenfeld ED et al. Ophthalmology 2007; 114(9):1653-62
3. Donnenfeld ED, Donnenfeld A. Int Ophthalmol Clin. 2006; 46(4):21-40
4. Baklayan GA et al. J Ocul Pharmacol Ther. 2008; 24(4):392-8
5. Nevanac, Summary of Product Characteristics: 2009
6. Acular, Summary of Product Characteristics: 16 Feb 2010
7. Voltarol, Summary of Product Characteristics: 04 May 2010
8. Committee for Medicinal Products for Human Use (CHMP) Assessment Report,
17 March 2011
035-2011-04-BMF
Date of preparation: June 2011
Yellox is a registered trademark used by Bausch & Lomb Incorporated by permission of Croma
Pharma GmbH.
Bausch + Lomb is a registered trademark of Bausch & Lomb Incorporated.
Yellox is licensed in all EEA member states, not in Switzerland
©
Bausch & Lomb Incorporated.
† Yellox is the first and only twice-daily topical ocular NSAID indicated
for the treatment of postoperative inflammation in patients who have
undergone cataract extraction.4 In a large phase III trial, BID Yellox for
14 days controlled ocular inflammation (SOIS=0) in 59.3% of patients
vs 26.9% with placebo (<0.0001).3
‡ Absorption occurs within 15 minutes, with peak aqueous humour
concentration at 150–180 minutes;1,2 in a phase III, placebo-controlled
trial significant clearance of ocular inflammation was as fast as 3 days
in some patients (8.4% with Yellox vs 1.2% with placebo, p=0.0012),
with significant efficacy persisting for 4 weeks3
*Yellox has demonstrated clinical efficacy in 2 weeks with BID dosing.
Treatment duration & dosing is relative to current clinical standards
across Europe as well as older available NSAIDs.1,2,5-7
§ Millions of ophthalmic uses and very low incidence of adverse events
(such as stinging and burning)1,4,8
o phthalmology F utures
2012
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PROGRAMME SPONSORS
SILVER
For surgeons who surgically treat and manage glaucoma
l
Ab-interno sub-conjunctival drainage delivered
minimally invasively
l
Clinically proven outflow pathway
l
Permanent, collagen derived, soft and
flexible gelatin implant
26970 Aliso Viejo Pkwy, Suite 200, Aliso Viejo, CA 92656 Tel: 949.450.0250 www.aquesys.com
MEDIA SPONSOR
o phthalmology F utures
2012
Eur op ea n forum
PROGRAMME SPONSORS
PLAT I NUM
Abbott Medical Optics (AMO) is focused on providing the full range of
advanced
professionals deliver optimal vision and lifestyle experiences to patients
of all ages.
Ophthalmic surgical products include intraocular lenses, laser vision
correction systems, phacoemulsification systems, viscoelastics and
related products used in cataract and refractive surgery. Contact lens
and eye care products include disinfecting solutions, enzymatic cleaners,
lens rewetting drops and dry eye drops.
AMO is headquartered in Santa Ana, California, and employs approximately
3,600 worldwide.
For more information, visit www.amo-inc.com
refractive
technologies
and
support
to
help
eye
THERE’S
O N LY O N E
care
PLATI NUM
As the global leader in eye care, Alcon’s mission is to provide innovative
products that enhance quality of life by helping people see better. This
mission means that Alcon’s more than 24,000 associates strive to make
significant contributions to preserve, restore and enhance vision.
Through the merger of Novartis and Alcon, uniting the strengths of Alcon,
CIBA VISION and Novartis Ophthalmics into one eye care business, Alcon
has become the second largest division of Novartis. With these collective
resources and scale, Alcon now offers the widest spectrum of eye care
products in surgical, pharmaceutical and vision care across 180 markets
and runs operations in 75 countries.
Alcon has nearly 2,000 people dedicated to research and development
around the world working to address the world’s most pressing eye care
needs. Our dedication to eye care extends to professional education at a
level unmatched in the industry.
For more information, visit www.alcon.com
Visit booth #N268 to find out how
you can lead the way with the
KAMRA™ corneal inlay by AcuFocus.™
For more information on AcuFocus Events at ESCRS,
download the AcuFocus App in the App Store or scan here:
The KAMRA Corneal Inlay
TM
Figure 1
In a 2009 report on world aging, the
United Nations reported the median
age for the European continent
was 40 years old, a figure which is
significantly higher than the global
median age of 28. Further the report
shared that of the 18 countries
worldwide with a median age of 40
years old or higher, 15 are located
in Europe.1 Combine that with the
fact that the average age of onset for
presbyopia in Europe is 45 and 83%
of the population will suffer from the
disease, and we see that presbyopia
is ubiquitous.2
Medical science has not been
ignorant of this phenomenon, and
after a decade of evolutionary
development, the KAMRA corneal
inlay (AcuFocusTM) has proven
itself as the solution for presbyopia
for patients and physicians. After
six generations of refinement,
the commercial KAMRA inlay is a
3.8mm ring with a central 1.6mm
opening. The annulus is made of
polyvinyledene fluoride (PVDF), is 5
μm thin and has 8,400 laser-etched
micro-perforations arranged in a
pseudo-random pattern (Figure 1).
This unique hole pattern was
designed especially to improve
nutrient flow and to reduce light
transmission and thus photic
phenomenon. Every element of the
design has been carefully considered
and clinically tested so that the end
result is a device that improves
focus at a range of distances
while allowing for a natural corneal
metabolic process.
postoperatively, with less dependence
on reading glasses.6 This includes
daily functions such as reading the
newspaper and driving at night.
The KAMRA inlay has now been
implanted in over 15,000 patients
worldwide with excellent clinical and
commercial results. Both clinical
and commercial results show that
with a small aperture inlay implanted
monocularly in the non-dominant eye,
patients achieve on average, J2 for
uncorrected near visual acuity (UNVA)
(Figure 2) 20/25 for uncorrected
intermediate visual acuity (UIVA) and
20/25 uncorrected distance visual
acuity (UDVA) in their inlay eye.
Binocularly, UDVA remains constant
from pre-op to post-op.3 Data out
to four years show that the effect is
sustained, that the cornea is stable
and the device is biocompatible
over time.4 With the inlay, patients
are also showing a reduction in
reading distance and improvements
in reading acuity and reading speed.5
Trials using the latest generation
of the inlay show that patients
experience little or no reduction
in contrast sensitivity and report
performing near, intermediate and
distance vision tasks with ease
Originally intended for emmetropic
presbyopes, physicians have found
that inlay implantation either with a
simultaneous LASIK treatment (CLK)
or after a prior LASIK procedure
(PLK) is very successful. Six-month
results of a study of 630 patients that
underwent a PLK procedure showed
that 91% of patients reported a
reduction in their dependence on
reading glasses; and 94% reported
satisfaction with their vision without
reading glasses. These patients
also experienced visual acuity gains
equivalent to reported results for
emmetropic presbyopes: mean
UNVA improvement from J8 to J2,
with mean UDVA reducing only one
line from 20/16 to 20/20.7
The outstanding track record shows
a presbyopia treatment option that
improves near and intermediate vision
while maintaining distance vision.
Perhaps the best endorsement is
the numerous physicians that are
choosing the KAMRA inlay as the
solution to their own presbyopia.
Figure 2: Contralateral
comparison of mean
UNVA for the inlay
implanted eye (IE),
fellow eye (OE) and
both eyes (BE) for a
series of 32 patients
shows that while the
fellow eye continues to
lose near acuity over
time, both the inlay
eye and binocularly
patients maintain
excellent near vision.
o phthalmology F utures
2012
E ur o pe a n f o r um
PROGRAMME SPONSORS
GOLD
AcuFocus™ Inc., a privately held company located in Irvine, California,
developed the KAMRA™ inlay for the treatment of near vision loss
(presbyopia). The KAMRA inlay is an intra-corneal inlay designed to
create a small aperture effect, allowing the eye to see near and
intermediate objects more clearly while maintaining distance vision. By applying the “depth-of-focus” principle
commonly used in photography, the KAMRA inlay controls light transmission, allowing only central rays to reach
the retina through a fixed 1.6mm aperture. More than 15,000 KAMRA inlays have been implanted and it is
available for sale in over 40 countries worldwide. The AcuFocus KAMRA inlay is a 2012 Medical Design
Excellence Awards® Finalist.
For more information about the KAMRA inlay from AcuFocus visit www.AcuFocus.com
GOLD
Bausch + Lomb, a global company solely dedicated to eye health and
one of the best-known and most respected healthcare brands in the
world, offers the widest range of eye health products including contact
lenses and lens care products, pharmaceuticals, intraocular lenses (IOLs)
and other eye surgery products.
After nearly 160 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and
motivated colleagues work relentlessly to invent new materials, engineer new technologies and ultimately bring
new innovations to help people see better to live better.
We market three broad categories of products:
Cataract and Vitreoretinal Surgery: We offer a full suite of ophthalmic surgical products, IOLs and delivery
systems. Our line of IOLs feature enVista® TORIC, enVista™, Akreos® MICS and Crystalens® AO. Our surgical
systems include the Stellaris® and Stellaris® PC line of phacoemulsification and vitrectomy equipment and the
VICTUS™ femtosecond laser platform, co-promoted with Technolas Perfect Vision GmbH (TPV). We also offer a
full range of surgical instruments and devices, including our signature Storz™ line of instruments and
viscosurgical devices, Amvisc® and Amvisc® Plus.
Pharmaceuticals: Our products treat a wide range of eye conditions including glaucoma, eye allergies and
dry eye. We offer proprietary and generic prescription medicines and OTC treatments. Our prescription products
include the NSAID eye drops Yellox, the steroid eye drops Lotemax, the Artelac® dry eye range, the nonselective beta blocker Carteol, and Liposic ointment for dry eye. Leading OTC products include the
Ocuvite and PreserVision ocular vitamins brands.
Vision Care: Our contact lens offerings span the entire spectrum of wearing modalities and include the
Biotrue™ ONEday, PureVision, SofLens, Boston and Optima brands. Our lens care products include
United Nations, “World Population Aging 2009”. Dec 2009.
Holden BA, Fricke TR, Ho SM, et al. Global vision impairment due to uncorrected presbyopia. Arch Ophthalmol. 2008;126(12):1731-39.
3
Data on file at AcuFocus.
4
Yilmaz et al. Intracorneal Inlay to Correct Presbyopia: Long-Term Results; JCRS July 2011; 37:1275-80.
5
Dexl AK, Seyeddain O, Riha W, Hohensinn M, Hitzl W, Grabner G. Reading performance after implantation of a small-aperture corneal inlay for the surgical
correction of presbyopia: Two-year follow-up. J Cataract Refract Surg. 2011;37:525-531.
6
Thompson V. Task performance after implantation of small aperture inlay to improve near vision. Presented at ASCRS Annual Meeting. San Diego, CA, May 2011.
7
Tomita M. Treatment of Post-LASIK Presbyopia with Small Aperture Corneal Inlay: 6-Month Results. Presented at ASCRS Annual Meeting. Chicago, IL, April 2012.
1
2
Biotrue and renu brands of multipurpose solutions for soft contact lenses and Boston products for cleaning GP
contact lenses.
For more information, visit www.bausch.com
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2012
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PROGRAMME SPONSORS
PROGRAMME SPONSORS
S I LV ER
SILVER
Amakem is a kinase platform company focusing on ophthalmology and
EyeTechCare is developing non-invasive therapeutic medical devices
is developing new treatments for serious eye conditions. Amakem’s
using HIFU technology (High Intensity Focused Ultrasound).
product pipeline is based on its unique ‘Localized Drug Action’ platform
which is designed to generate safe and effective novel kinase inhibitors
EyeOP1®, the first device developed by the company, was conceived
that minimize systemic exposure with the aim of reducing side effects.
for the treatment of glaucoma. The EyeOP1® system has been
undergoing clinical trials since 2010 and is due to be launched onto
Amakem’s lead candidate, AMA0076, is a novel, highly potent Rho Kinase (ROCK) inhibitor targeted at the
the market very soon. The device utilizes the UC3® (Ultrasound
treatment of glaucoma, a condition which damages the optic nerve resulting in vision loss and ultimately
Circular Cyclo-Coagulation) technique which makes it possible to
blindness. AMA0076 has been shown in a number of in vivo models to be highly effective in reducing
reduce intraocular pressure by coagulating targeted sections of the
intraocular pressure (IOP), a major factor in glaucoma, while avoiding hyperemia. Conjunctival hyperemia
ciliary body with pinpoint accuracy.
is a distressing and dose limiting side effect for patients that has hindered the progress of many otherwise
EyeTechCare, 2871 Avenue de l’Europe, 69140 RILLIEUX LA PAPE, France.
Phone: +33 4 78 88 09 00, Fax: +33 4 78 97 45 11.
Email: [email protected].
Website: www.eyetechcare.com
promising glaucoma drugs.
Amakem is working to apply the ‘Localized Drug Action’ platform to several other ophthalmology and
non-ophthalmology indications such as COPD (Chronic Obstructive Pulmonary Disease), asthma and IBD
(inflammatory bowel disease).
Amakem is based in Belgium and located in the life sciences incubator “BioVille” at the University of Hasselt.
For more information, visit www.amakem.com
SILVER
S I LV ER
Icon Bioscience, Inc., is a privately held biopharmaceutical company
AqueSys, Inc. is a privately-held, venture capital funded ophthalmic
focused on the development and commercialization of novel ophthalmic
company headquartered in Aliso Viejo, California. The company is
pharmaceuticals based on its Verisome® drug delivery technology. Icon is
focused on the research, development, manufacturing and distribution
developing a broad portfolio of clinically superior specialty pharmaceuticals
of implantable devices used to surgically treat and manage glaucoma
targeting all major ophthalmic indications.
patients. AqueSys® was granted CE mark in 2010/2011 for two of
Icon has six portfolio products, based on Verisome technology in
development. IBI-10090 is in Phase 3 development for the treatment of
inflammation associated with cataract surgery. This trial is expected to be
The AqueSys® Implant(s) is the first minimally invasive glaucoma procedure designed to safely provide gold
completed in late 2012. IBI-20089 for uveitis will enter Phase 3 development
standard IOP reduction via an adoptable ab interno procedure that bypasses all potential outflow obstructions
in mid-2013. Icon’s glaucoma product, IBI-60090, is scheduled to enter
and minimizes postoperative management of complications. A permanent, soft, collagen-derived, gelatin
clinical trials in early 2013.
The Verisome® drug delivery technology was invented by Dr. Vernon G.
its portfolio products, and these and other products are currently being evaluated in several multi-center
clinical studies in the US and abroad.
implant gently creates diffuse outflow into the eye’s non-dissected Tenon’s and subconjunctival tissue which
is a globally accepted and clinically proven drainage location.
Wong, founder of Icon. Highly versatile, it is capable of delivering small
The straightforward technology and procedure are designed for surgeons who surgically treat and manage
molecules, proteins and monoclonal antibodies in a controlled release
glaucoma. The minimally invasive approach is both removable and repeatable. Once in the eye, a single
manner for up to a year with a single intraocular injection. Icon has also
implant is designed to provide significant, long-term IOP control, which may reduce the risk of glaucoma
entered into select agreements with multiple international pharmaceutical
disease progression in mild, moderate and refractory glaucoma patients.
companies. Icon has a strong ever growing global intellectual property
AqueSys, Inc., 9834 Research Drive, Irvine, CA 92618. Telephone: +1.949.450.0250. Fax: +1.949.450.0249
estate.
Website: www.aquesys.com
For more information, visit www.iconbioscience.com
o phthalmology F utures
2012
E ur o pe a n f o r um
InnFocus MicroShunt™
PROGRAMME SPONSORS
SILVER
Innovation in biomaterial-driven
device design for the treatment
of Glaucoma is our Focus…
• Proprietary
non-inflammatory
material (SIBS)
• Designed to deliver
significant reduction
in IOP and medication
dependence
• Simplified post-op
management
• CE Mark granted
January 2012
InnFocus is a privately-held, venture capital-backed company dedicated to
treating glaucoma by reducing intraocular pressure to a safe level with no
progression of vision loss. The InnFocus MicroShunt,™ also known as the
“MIDI Arrow,” is an ab externo, plate-less glaucoma drainage implant used to
shunt aqueous humor from the anterior chamber to a sub-conjunctival/
Tenons flap. The Company’s founders previously developed a novel
non-inflammatory inert biomaterial called “SIBS,” which enabled the leading
drug eluting coronary stent. SIBS has enjoyed over a decade of human use
and was reformulated by InnFocus specifically for the MicroShunt. The
MicroShunt (0.35 mm in diameter x 8.5 mm long) has a 70 μm diameter
lumen which acts as a flow resistor to drop IOP to a safe level. Small “fins”
located on the tube prevent peri-tubular leakage and migration of the
device. The reformulated SIBS biomaterial matches the compliance of tissue,
assumes the shape of the eye, is atraumatic and non-erosive, dampens
pressure spikes, does not interfere with MRI and demonstrates clinically
insignificant inflammation and encapsulation. The device was designed to
be used in conjunction with Mitomycin C.
An ongoing two-year clinical study with over sixty patients uncontrolled on
glaucoma medication demonstrates excellent effectiveness in reducing
intraocular pressure by 55% with no long-term adverse events and with
>85% patients off glaucoma medication at one year. The InnFocus
MicroShunt™ is implantable in a simple, safe and fast procedure, in
combination with cataract surgery or alone, using techniques very familiar to
ophthalmologists.
ophthalmologists for the treatment of mild to moderate glaucoma.
InnFocus, Inc., 12415 SW 136th Avenue, Unit #3, Miami, Florida, U.S.A.
Contact Bruce A. Weber, VP of Regulatory, Clinical and Quality Assurance,
Tel. (305)378-2651 ext. 371, Fax (305)378-2652
Email [email protected] Web: www.innovia-llc.com
The
millimetres
Company
intends
to
sell
the
device
to
SILVER
InnFocus MicroShunt
™
(formerly MIDI Arrow)
www.Innovia-llc.com
Vice-President, Clinical,
Regulatory & QA InnFocus, Inc.
12415 S.W. 136 Ave. Unit 3
Miami, FL 33186 USA
Tel: (305) 378-2651, Ext. 371
Email: [email protected]
Ernie Edwards
Chief Commercial Officer
InnFocus, Inc.
One Embarcadero Centre, Suite 500
San Francisco, CA 94111 USA
Tel: (805) 459-2475
Email: [email protected]
DWG-1INF-0174-00R01
Bruce Weber
Ivantis, Inc. is a company dedicated to the development of new and
innovative solutions for glaucoma. Current therapies for primary open angle
glaucoma (POAG) include eye drops, laser therapy, and surgery. But each of
these has its limitations. Glaucoma remains the leading cause of blindness
worldwide, in need of better treatment alternatives. It is Ivantis’s goal to
develop new and effective solutions for ophthalmology specialists and the
70 million people worldwide who are affected by this debilitating and
sight-stealing disease.
For more information, visit www.invantisinc.com
o phthalmology F utures
2012
E ur o pe a n f o r um
PROGRAMME SPONSORS
SILVER
Refocus Group, Inc. is a medical device company engaged in the
research and development of treatments for human vision disorders.
Our mission is to become the surgical standard of care for presbyopia,
primary open-angle glaucoma and ocular hypertension worldwide.
Refocus Group’s main product is PresVIEW™, which is a scleral
implant used in an innovative procedure to improve and help restore
the natural accommodative process of the visual system that has
deteriorated in the aging eye. Refocus Group is currently investigating
the safety and efficacy of PresVIEW™ in a multi-center clinical study
in North America, as yet it does not have FDA approval. In Europe the
company is about to commence a multi-center clinical study for
presbyopia in addition to a multi-center glaucoma study. PresVIEW™
has CE Mark approval in Europe.
For further information on Refocus Group or PresVIEW™, please contact
Doug Williamson, CEO, Refocus Group.
For more information, visit www.refocus-group.com
SILVER
ReVision Optics, Incorporated, (RVO) is a privately held corporation
headquartered in Lake Forest, California. The company’s main focus is the
research and development of minimally invasive implantable devices for the
treatment of presbyopia.
RVO’s current product portfolio includes the Raindrop™* Near Vision Inlay.
Raindrop, which is 2mm in diameter and comprised of approximately 80%
water, is placed just beneath the surface of the eye. The Raindrop is as
transparent as natural tears and is less than half the thickness of a human
hair. The implant procedure takes approximately fifteen minutes, typically
results in patients being able to read the newspaper, a menu, or their
iPhone® again, in only a few short days. These positive clinical results are
reflected in a recent survey, where 93% of the commercial patients
expressed satisfaction with their Raindrop experience.
The Company is actively pursuing regulatory approvals and market
opportunities for the Raindrop worldwide. The Raindrop has received CE
mark
is headquartered at 25651 Atlantic Ocean Drive, Suite A1, Lake Forest,
California
www.revisionoptics.com
*Caution: Investigational Device. Limited by Federal (United States) law to investigational use.
and
is
authorized
92630.
For
for
more
sale
in
the
information
European
on
RVO,
Union.
please
RVO
visit
o phthalmology F utures
2012
E ur o pe a n f o r um
PROGRAMME SPONSORS
SILVER
Santen is a pharmaceutical company specialized in the development and
manufacturing of ophthalmic pharmaceuticals and OTC eye care and
headquartered in Osaka, Japan. Founded in 1890, it is the oldest
ethical ophthalmic company in the world and today is a fully integrated
global company with global R&D, manufacturing and marketing
capabilities. Santen is the market leader in ophthalmic pharmaceuticals in Japan and China. In Japan Santen
has also ophthalmic surgical and rheumatology business units.
The company’s strong identity is perfectly represented by its Core Value: Tenki ni sanyo suru*, meaning
we think carefully about what is essential, decide clearly what we should do, and act quickly.
With strong marketing bases in Japan, United States and Europe, backed by state-of-the-art manufacturing
and R&D capabilities, Santen aims to increase corporate value as a specialty care company that delivers
unique products addressing unmet need in eye care to patients worldwide.
Santen in Europe
Employing about 560 people Santen Europe has a well-developed and internationally integrated network of
competencies.
The European Strategic HQ, located in Munich, Germany, is the base for the corporate functions of Business
Development and Product Planning, Corporate Development, Sales and Marketing, and Regulatory Intelligence.
The European Operational HQ located in Tampere, Finland, is where the prestigious Formulation R&D and
Manufacturing facility of Santen Europe are located. Corporate functions of Formulation Development,
Manufacturing and Quality, Finance and Administration are based here.
In December 2011 Santen completed the acquisition of Novagali. The promising pipeline of Novagali
seamlessly fits with Santen’s existing portfolio and represents a significant step forward to meet Santen’s
long-term growth expectations and to strengthen its global business platform, especially its business
franchises in Europe. Novagali has outstanding R&D capabilities with its technology platforms Novasorb® and
Eyeject® and is located in Evry, France.
For more information please visit the links: www.santen.eu and www.santen.eu/eu/BusinessDevelopment
*Santen’s original interpretation of a passage from chapter 22 of Zhongyong (The Doctrine of the Mean) by Confucius, meaning
“exploring the secrets and mechanisms of nature in order to contribute to people’s health.
SILVER
Established in 2003, Sensimed AG is a Swiss company with its principal
focus on design, development and commercialization of integrated
micro-systems for medical devices. Sensimed was spun off from the
well renowned Swiss Federal Institute of Technology (EPFL) and
grows within a world-leading cluster for medical devices in the lake
of Geneva area (Switzerland).
Sensimed has developed a new, patented, non-invasive product that will significantly improve identification
and treatment of glaucoma disease by monitoring intraocular pressure around the clock. In 2009 Sensimed
received the CE mark for the SENSIMED Triggerfish® system. The company focuses on conducting clinical trials
on human beings in well renowned centers worldwide, and initiated controlled commercialization in selected
countries. The SENSIMED Triggerfish® is a paradigm shift in ophthalmology and a step forward in glaucoma
patient management. The system comprises a soft contact lens embedded with a miniaturized telemetric
sensor. A flexible adhesive antenna worn around the eye is connected to a portable recorder and wirelessly
connects to the contact lens to continuously acquire monitoring information. The patient can wear the system
for up to 24 hours and can perform every day activities – including sleeping. The data collected at the end
of the monitoring session provides specialists with previously unknown clinical data in real life conditions,
enabling the choice of customized therapy for patients diagnosed with a glaucoma condition. Contact:
Jean-Marc Wismer, CEO – [email protected]. For more information visit www.sensimed.ch
o phthalmology F utures
2012
E ur o pe a n f o r um
PROGRAMME SPONSORS
SILVER
Transcend Medical is focused on the development of minimally invasive
Ophthalmology Times Europe is a comprehensive publication covering all of the latest
developments within the ophthalmic industry with a broad focus on cataract, corneal and
refractive surgery, as well as glaucoma and vitreoretinal conditions.
EnsurE you kEEp up-to-datE with
thE currEnt nEws by subscribing
to otEuropE today.
medical devices for the treatment of glaucoma, the leading cause of adult
irreversible blindness. Over 4 million people in the U.S. and roughly 60 million
worldwide are afflicted with the disease today and the numbers are
expected to grow to nearly 6 million in the U.S. and over 70 million worldwide
by the year 2015.
The Transcend mission is to change the paradigm in glaucoma treatment by
introducing a minimally invasive yet highly effective procedure that will allow
for earlier surgical intervention. The flagship Transcend product, the CyPass
MicroStent®, is targeted at the largest glaucoma segment - patients with
mild-to-moderate glaucoma.
The CyPass Micro-Stent is the first ab interno suprachoroidal device
intended to lower lOP while reducing or eliminating the need for glaucoma
medication. In the U.S. the CyPass Micro-Stent is an investigational device
currently being studied in one of the largest, randomized, controlled surgical
glaucoma studies ever conducted - the COMPASS multi-center clinical trial
(www.compassclinicalstudy.com). It is estimated that as many as 800,000
patients a year could potentially benefit from the CyPass Micro-Stent
procedure in the US alone.
For more information, visit www.transcendmedical.com
Ophthalmology Times Europe – Weekly e-newsletter
Providing the latest news on market developments, trends, surveys
and industry events, the weekly e-newsletter is delivered to
industry professionals worldwide.
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Ophthalmology Times Europe (OTE) is a leading media resource for the
European ophthalmology community. Its products have a broad focus on
cataract and refractive surgery, glaucoma and vitreoretinal conditions. In
addition to being a forum for surgeons to communicate their clinical
knowledge, insight and procedures OTE reports on all major European
news, events and industry trends.
Its Editorial Advisory Board of key European opinion leaders provides timely
coverage and expert opinion on all the latest research findings and issues
affecting the industry.
It reaches a pan-European audience via print, on the web and directly to
the inboxes of Europe’s leading surgeons.
www.oteurope.com
SAVE THE DATE
o p h t h al mo lo gy F ut u r e s
2 0 13
o phthal m o l o gy F u tu r es A dvis o r y p a n e l
The Ophthalmology Futures Advisory panel includes:
Jorge Alio
Section Head, Institution Ophthalmology of Alicante, Vissum, Spain
Keith Barton
Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Beatrice Cochener
Professor, Chairman, Ophthalmology Department, University Hospital,
Brest. President, French Academy of Ophthalmology, France
Emmett Cunningham
Partner - Clarus Ventures. Adjunct Clinical Professor of Ophthalmology,
Stanford University, Stanford, USA
Sheraz Daya
Chairman and Medical Director, Centre for Sight. Faculty, University Hospital,
Brest, France
Tuomas Huuhtanen
Director of Marketing, Santen, Finland
Michael Knorz
Medical Director, CEO, FreeVis LASIK Group, Mannheim, Germany
John Marshall
Frost Professor of Ophthalmology, Institute of Ophthalmology, University College,
Moorfields Eye Hospital. Emeritus Professor of Ophthalmology at King’s College,
St. Thomas’ Hospital, London, UK
Eu ro pean FORUM
Bringing together ophthalmic innovation, financial expertise and corporate leadership
James Mazzo
President, Abbott Medical Optics, Senior VP, Abbott Laboratories, USA
Paul Rosen
Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford, UK
amsterdam
October 2013
Visit
www.ophthalmology-futures.com
for updates
Baldo Scassellati Sforzolini
VP Global Drug Development, Bausch + Lomb, USA
Kuldev Singh
Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA
Julian Stevens
Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK
The organising committee for the Ophthalmology Futures 2012 European Forum
Keith Barton
SUPPORT I NG I MPRO V E D O C ULAR HEALTH
Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Ophthalmology Futures 2012 European Forum - in partnership
with the following organisations and charities.
Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA
Kuldev Singh
Abigail Mackrill
Operational Director, Ophthalmology Futures, UK
Brigid Barton
Director, Vision Futures, UK
Secretariat
WBR Limited, Tunbridge Wells, UK
Moorfields Eye Hospital
Vision Futures Limited, London, UK, registered in England No: 8125858