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Recent Developments in the Vision Care Industry
BSS RECALL
The US FDA issued a recall for a common
brand of balanced salt solution used in
cataract surgery made by Cytosol
Laboratories.The agency cited problems
with elevated levels of endotoxin that could
cause a wide variety of serious reactions
such as fever, shock and changes in blood
pressure and other circulatory functions.
The FDA noted that more than 300 patients
developed problems including Toxic Anterior
Segment Syndrome (TASS). Physicians and
consumers have been instructed to
discontinue using all products made
between December 2003 and December
2005, under three labels:“AMO Endosol,”
distributed by Advanced Medical Optics, Inc.
(AMO);“Cytosol Ophthalmics,” distributed
by Cytosol Ophthalmics; and “Akorn,”
distributed by Akorn, Inc.
(www.fda.gov/medwatch)
DisCoVisc goes to Brazil
Alcon launched its viscosurgical product
DisCoVisc (sodium chondroitin sulfate 4%,
sodium hyaluronate 1.65%) on the Brazilian
market during the World Ophthalmology
Congress in Sao Paulo.The product is
intended for use during all stages of anterior
segment surgery.The product combines the
properties of cohesive and dispersive
viscoelastic agents. (www.alconlabs.com)
Macugen goes to Europe
Pfizer has announced that the European
Commission has granted marketing
authorisation for Macugen® (pegaptanib
sodium injection) for the treatment of
neovascular (wet) age-related macular
degeneration. Macugen is the first therapy
indicated in Europe for the treatment of all
types of wet AMD, regardless of lesion
subtype, size or visual acuity.The approval
was based on the results of two pivotal
clinical trials involving 1,186 patients with all
subtypes of wet AMD.The drug was
approved in the US in December 2004.The
company launched the product in Latin
America during the World Ophthalmology
Congress in São Paulo, Brazil. (Macugen.com)
New ORK-CAM from Schwind
Schwind eye-tech-solutions launched a new
version of its ORK-CAM diagnostic system.
The ORK Workstation integrates the
topography system for measurement of
Journal Watch
corneal wavefront, and the aberrometer for
the measurement of ocular wavefront, at
one workplace.The wavefront data of the
cornea and the entire eye are synchronised
and calculated.The doctor manages data
measurement with both devices from one
Panel-PC, while the patient merely changes
chin rests.The system includes a wireless
LAN connection.
(www.eye-tech-solutions.com)
Glaucoma combo
Alcon advanced one step closer to
European approval of its DuoTrav solution
(travoprost 0.004%/timolol 0.5%) after
gaining a positive opinion from the
Committee for Medicinal Products for
Human Use (CHMP).The approval sets the
stage for marketing authorisation of
DuoTrav eye drops solution in the
European Union to decrease IOP in
patients with open-angle glaucoma or
ocular hypertension who are insufficiently
responsive to topical beta-blockers or
prostaglandin analogues.The marketing
authorisation is expected to be finalised in
the second quarter of 2006. DuoTravTM eye
drops solution is approved in Australia and
is also under review in other countries.
Alcon estimates the European glaucoma
market to be more than $1.1bn, with
almost 10% of the market comprised of
combination prostaglandin analogue
products. In order to accelerate product
acceptance, the company will actively
pursue reimbursement in each of the 25 EU
member countries. (www.alconlabs.com)
IntraLase keratoplasty
IntraLase Corp. announced the successful
performance of the first corneal transplant
cases using the IntraLase® FS laser.The
company said that the use of IntraLase’s
femtosecond laser to create a contoured,
full-thickness corneal resection in
preparation for corneal transplant has the
potential to make corneal transplantation a
safer, more precise procedure as the alllaser approach gains favour among
transplant surgeons. Full global launch of
this new therapeutic application is expected
in Autumn 2006. (www.intralase.com)
by Sean Henahan
Vision science highlights from the world’s leading journals of medicine and science
Blue light special?
Do yellow-tinted intraocular lenses really provide any
additional benefit to cataract patients? Blue-light filtering
IOLs now on the market were designed to filter out light in
the blue end of the spectrum believed to be particularly
destructive to aging RPE cells. The hypothesis is that such
lenses would potentially protect against the development of
macular disease. JCRS Editor Emanuel Rosen FRCSE
evaluates the science behind these claims in an editorial. He
notes that the literature on the contribution of UV and blue
light to the degeneration of the macula through deleterious
effects on the central retinal pigment epithelium and
photoreceptors is equivocal. He adds that it would be
difficult if not impossible to design the appropriate clinical
case-control studies. After reviewing the current state of the
debate, including a recent presentation by Dr Mainster in
Lisbon raising the spectre of diminished scotopic sensitivity
with blue-blocking IOLs, Dr Rosen concludes that for the
moment the best philosophy is “Be safe rather than sorry”.
Dr Rosen was inspired in part by an article in the JCRS by
Prof John Marshall that presents clinical results of a currentgeneration blue-light-filtering intraocular lens. Two hundred
and ninety-seven patients in a multicentre prospective
randomised patient-masked study received the Acrysof
Natural IOL or the Acrysof single-piece IOL.The study found
no statistically significant differences between the two
patient groups in visual acuity, contrast sensitivity evaluated
under mesopic and photopic conditions or the number of
patients who passed the Farnsworth D-15 colour perception
test. There were no lens-related adverse events in either
group.
The authors note: “Additional long-term studies should be
able to show whether the lens actually provides the
theoretical benefits to retinal health.”
E Rosen, JCRS, ‘A l'oeil malade la lumiere nuit’, December 2005, Vol. 31,
Issue 12, 2237-2238.
J Marshall et al., JCRS, ‘Clinical results of the blue-light filtering Acrysof
Natural foldable acrylic intraocular lens’,
December 2005,Vol. 31, Issue 12,
pages 2319-2323.
Glaucoma pandemic forecast
The global toll of glaucoma is set to reach 60 million by 2010,
rising to almost 80 million by 2020, a new analysis suggests.
The authors reviewed all the data on glaucoma derived from
studies based on populations. These figures were then used
to calculate rates of the disease by age, sex and ethnicity, in
combination with United Nations projections for world
population. Based on their calculations, the authors predict
that 8.5 million people will be blind in both eyes as a result
of glaucoma by 2010, a figure that will rise to more than 11
million people by 2020. They believe women, and people
living in Asia, Africa and India will be worst affected. The
authors cite the urgent need to improve diagnostic and
therapeutic approaches to open- and closed-angle glaucoma
that could be applied around the world. An accompanying
editorial points out that efforts to tackle the disease have
been hampered by a lack of consensus on the definition of
the disease and the absence of a simple and accurate
screening test.
HA Quigley et al., BJO,‘The number of people with glaucoma worldwide in
2010 and 2020’, 2006; 90: 262-7.
RRA Bourne, BJO,‘Worldwide glaucoma through the looking glass”, 2006; 253-4.
Humour declines with age
Aqueous humour volume declines steadily with age, a
longitudinal Swedish study indicates. Researchers evaluated the
aqueous humour and corneal volumes, correlations to age, sex
and refractive status of 153 eyes of healthy volunteers and 58
eyes of cataract surgery candidates. They followed 16 patients
for four years.The study found that the aqueous humour volume
was inversely correlated to the age of the individual, with an
average decrease of 1.4ml per year. They observed that the
posterior part of the anterior chamber underwent a
pronounced reduction in volume with time, whereas the volume
of the anterior part increases slightly with time. Increasing age
also brought increasing steepness and peripheral thinning of the
cornea and a reduction in corneal volume. The authors note that
these alterations could be of importance in planning refractive
procedures and in evaluating disease processes.
M Jonnson et al., Acta.Ophth. Scan., ‘Slit-scan tomography evaluation of the
anterior chamber and corneal configurations at different ages’, February 2006,
Volume 84, 116.
Two genes play role in majority of AMD
Two genes, Factor H and Factor B, have been found to play a role
in nearly 75% of cases of AMD. The current work builds on
research released last year showing the importance of the Factor
H gene in AMD pathogenesis. Researchers now report that a
second gene, Factor B, may work in tandem with Factor H. Both
are believed to play roles in regulating the immune inflammatory
response. EuroTimes will discuss this work in detail in the May
2006 issue.
B Gold, et al., Nature Genetics, ‘Variation in factor B (BF) and complement
component 2 (C2) genes is associated with age-related macular degeneration’,
March 2006,Adv. Online Publication.
EuroTimes April 2006