Month: May 2014

In response to the CDC health
alert about an outbreak of Acanthamoeba keratitis, a rare but serious eye
infection, the American Academy of Ophthalmology is offering advice to all
contact lens wearers to reduce their risk of eye infections.

“More than 30 million Americans wear contact lenses,” says H. Dunbar
Hoskins Jr., MD. executive vice president of the Academy. “While the risk
of infection remains low, contact lenses are medical devices that require
the commitment of their wearers to handle and care for them correctly.
Proper lens care is critical to ensure that your eyes are protected from
potentially dangerous eye disease.”

The Academy offers the following tips for consumers:

— Stop using Complete MoisturePlus by Advanced Medical Optics (AMO).
Discard any unused solution, including partially used or unopened
bottles. Discard lenses stored in the solution and the cases used to
store those lenses.

— Consult your eye care professional concerning use of an appropriate
alternative contact lens solution.

— Wash hands with soap and water and dry before handling contact lenses.

— Do not use tap water to rinse your lenses.

— Read and follow the instructions for your contact lens solution.

— Consider performing a “rub and rinse” lens cleaning method, rather than
a no-rub method, regardless of the type of cleaning/disinfecting
solution that you use, in order to minimize the number of germs on the
lens. After rubbing, rinse lenses thoroughly with a multipurpose
disinfecting solution.

— Fill your contact lens case with fresh solution from the bottle each
time you clean the lenses. Never reuse old solution or “top off” old
solution in the storage case.

— Do not transfer contact lens solution from its original container to
anything other than storage cases.

— Remove the lenses and consult your ophthalmologist immediately if you
experience symptoms such as redness, pain, tearing, increased light
sensitivity, blurry vision, discharge, or swelling.

— Any eye infection is a serious medical problem that requires medical
care. If you think you have an eye infection, see an ophthalmologist,
who is a medical doctor trained to diagnose and treat eye problems.

In addition, the Centers for Disease Control and Prevention has these
additional recommendations:

— Remove contact lenses before any activity involving contact with water,
including showering, using a hot tub, or swimming.

— Rinse storage cases with sterile contact lens solution (never use tap
water) and leave the cases open to dry after each use.

— Replace your lens case at least every three months.

For more information about Acanthamoeba keratitis or about contact
lenses, please visit eyecareamerica.

About the American Academy of Ophthalmology

The American Academy of Ophthalmology is the world’s largest
association of eye physicians and surgeons — Eye M.D.s — with more than
27,000 members worldwide. Eye health care is provided by the three “O’s” —
opticians, optometrists and ophthalmologists. It is the ophthalmologist, or
Eye M.D., who can treat it all: eye diseases and injuries, and perform eye
surgery. To find an Eye M.D. in your area, visit the Academy’s Web site at
aao.

American Academy of Ophthalmology
aao

The use of statins is linked with a lower incidence of nuclear cataract, the most common type of age-related cataract, according to a study in the June 21 issue of JAMA.

Statins are widely used to decrease serum cholesterol for cardiovascular disease prevention. Statins have also been shown to have antioxidant activity. Oxidative stress (a condition in which antioxidant levels are lower than normal) has been thought to be a risk factor for age-related cataract, particularly nuclear cataract (the most common type of age-related cataract, which occurs in the center of the lens). Some evidence has suggested an association between nutritional intake of antioxidants and age-related cataract, according to background information in the article.

Barbara E. K. Klein, M.D., M.P.H., of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues analyzed data from the Beaver Dam Eye Study to determine if statin use is associated with a reduced risk of age-related cataract. The analysis included 1,299 persons who were examined as part of the study in 1998-2000 and were deemed to be at risk of developing nuclear cataract within 5 years.

A total of 210 persons developed incident nuclear cataract in the interval from 1998-2000 to 2003-2005. The five-year incidence of nuclear cataract was 12.2 percent in statin users compared with 17.2 percent in nonusers; the odds of developing cataract were 40 percent lower for statin users after adjusting for several factors. Because smoking and diabetes increase risk of nuclear cataract, the authors analyzed results in never smokers without diabetes, and found the odds of developing nuclear cataract was 60 percent lower among statin users after adjusting for other factors. The incidence of two other types of cataracts, cortical and posterior subcapsular cataracts, did not differ significantly between statin users and nonusers.

To further explore the relationship between statin use and nuclear cataract, the authors suggest that clinical trials of statins used for lipid lowering should assess nuclear cataract. In addition, they state “further study of the relationship of cataract and statin use is needed in which each type of cataract is considered individually. Further follow-up of our cohort, with anticipated increase in number of persons with cataract and wider use of statins, will permit us to evaluate whether our finding persists.”

(JAMA. 2006;295:2752-2758.)

The National Eye Institute provided funding for the entire study; Research to Prevent Blindness, New York, N.Y., provided further additional support for data analyses.

Contact: Sayward Proctor

JAMA and Archives Journals

Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, has announced positive data from a Phase 2 clinical study evaluating RX-10045, a resolvin administered as a topical eye drop for the treatment of patients with chronic dry eye syndrome. In this 28-day, randomized, placebo-controlled, 232-patient trial, RX-10045 produced dose-dependent, statistically significant improvement on the primary endpoints for both the signs and symptoms of dry eye, and was generally shown to be safe and well tolerated. These Phase 2 results represent the first demonstration of clinical efficacy for the novel class of resolvin compounds and suggest that resolvins have the potential to treat a broad range of inflammatory diseases.

“There is an urgent need for new treatment options in dry eye and the results of this Phase 2 study are as strong as any I have seen,” said Stephen Pflugfelder, MD, an expert in dry eye at Baylor College of Medicine. “Based both on these clinical results and on its unique mode of action, I am confident that RX-10045 can be an important new treatment modality for these patients.”

The 28-day, randomized, multi-center, placebo-controlled study in 232 patients with moderate dry eye patients was designed to evaluate the safety, tolerability and efficacy of RX-10045 administered twice daily. The Phase 2 study examined three doses of RX-10045 and utilized a controlled adverse environment (CAE) to measure corneal staining in a stressful drying environment, as well as daily patient diaries using a standard visual analog scale to assess symptom improvement over the course of the study.

RX-10045 produced a significant dose-dependent improvement from baseline in symptoms recorded in daily patient diaries. The improvement was observed across all symptoms evaluated in the study, including dryness, stinging, burning, grittiness, ocular discomfort and the composite of each patient’s most severe symptom (Worst Symptom Score). RX-10045 was superior to placebo on the primary symptomatic endpoint of Worst Symptom Score (p < 0.02), as well as on several individual symptoms. The onset of symptom relief occurred within the first week of treatment, and symptoms continued to improve over the course of the 28-day study, suggesting the potential for even greater benefit with longer treatment durations. “I am very encouraged by the symptom relief achieved with RX-10045,” said Ira Udell, M.D., Chairman of the Department of Ophthalmology at the North Shore-Long Island Jewish Health System and Professor of Ophthalmology and Visual Sciences, Albert Einstein College of Medicine. “Symptomatic improvement is what really matters to patients.” RX-10045 also produced a 75% reduction from baseline in CAE-induced staining of the central cornea (p < 0.00001), the primary sign endpoint in the study. This improvement was greater than that observed for placebo, the difference approaching statistical significance (p = 0.11). RX-10045 also produced a significant improvement in CAE-induced staining in the inferior cornea and in the composite of central and inferior cornea, which also approached statistical significance over placebo (p = 0.09). “We are very enthusiastic about the results of this Phase 2 study both as a demonstration of the potential of RX-10045 to treat dry eye patients and as the potential of the entire resolvin class to treat a range of inflammatory diseases,” said Greg Weinhoff, Executive Chairman of Resolvyx. “The results of this study will help Resolvyx design the pivotal trials for RX-10045, which are currently targeted to begin in the first half of 2010.” Resolvyx is also currently conducting a Phase 1 study with a second resolvin, RX-10001, an orally-administered drug candidate for the treatment of systemic inflammatory diseases such as asthma, inflammatory bowel disease and other inflammatory diseases. Source:
Kathryn Morris

Yates Public Relations

Emory Eye Center will host the 25th Southeastern Vitreoretinal Seminar (SEVR) at the Eye Center’s Calhoun Auditorium within the Learning Resources Center in The Emory Clinic, Building B. The meeting will take place from 8 a.m. to 5 p.m. on Friday, Feb. 11, and from 8 a.m. to noon on Saturday, Feb. 12. The annual seminar addresses issues of the retina and treatments for its various disorders.

The retina is the light-sensitive layer of tissue that lines the inside of the eye and sends visual messages through the optic nerve to the brain. Disorders and diseases of the retina include age-related macular degeneration, diabetic retinopathy, retinal detachments, macular holes and puckers, and retinopathy of prematurity (ROP), among others.

Notes:

For more Information click here.

Source:
Joy Bell
Emory University

One donor cornea may be divided and transplanted into multiple patients with eye disease or damage, according to a report in the April issue of Archives of Ophthalmology, one of the JAMA/Archives journals.

Transplantation of the cornea, the clear membrane that covers the front of the eye, was first performed in 1905, according to background information in the article. Recent developments have allowed ophthalmologic surgeons to move from transplanting the entire cornea in every patient to more focused operations that involve removing and replacing only the diseased or damaged portion of the cornea. “Such surgical techniques provide an opportunity to make use of a single donor cornea in more than one patient,” the authors write.

Rasik B. Vajpayee, M.S., F.R.C.S., F.R.A.N.Z.C.O., then of the All India Institute of Medical Sciences, New Delhi, and now of the University of Melbourne, East Melbourne, Australia, and colleagues used one cornea from a 44-year-old donor who had died of cardiac arrest to complete transplants in three patients. The corneal tissue was divided into three parts.

The first patient, a 40-year-old man, had a degenerative cornea disease that appeared only to affect the front two-thirds of his corneal tissue. He received the front portion of the donor cornea through a procedure known as automated lamellar therapeutic keratoplasty (ALTK), in which a thin slice of tissue is removed. His visual acuity before surgery was 20/200.

The second patient, a 60-year-old man, developed complications following cataract surgery and had a visual acuity of 20/400. He received the rear portion of the cornea through a technique known as Descemet stripping automated endothelial keratoplasty (DSAEK), which involves replacing damaged endothelium, or the layer of cells on the inside of the cornea.

The third patient was a 5-year-old boy who had chemical burns in his right eye. Stem cells from the donor cornea, at the junction of the cornea and conjunctiva (the membrane that covers the outer eye and inner eyelid), were transplanted to improve his vision, which was limited to counting fingers close to his face.

The procedures were all performed on the same day and were all successful. New tissue grew over the transplant in the ALTK patient after four days, and after three months the patient’s visual acuity improved to 20/60. In the DSAEK patient, minor swelling in the graft cleared within two weeks, and visual acuity improved to 20/40 after three months. New tissue grew in the child after one week, and at the three-month follow-up visit, his vision had improved to 20/200.

“Our strategy of using a single donor corneal tissue for multiple patients opens up the possibility of optimal use of available donor corneal tissue and will reduce the backlog of patients with corneal blindness in countries in which there is a dearth of good-quality donor corneal tissue,” the authors write. This includes India, where 300,000 donor corneas are needed each year but only 15,000 are available, with almost half of those unsuitable for transplantation. “With more corneal surgeons converting to techniques of customized component corneal transplantation in the form of anterior and posterior lamellar disc corneal transplantation, the use of a single donor cornea in more than one patient may become standard surgical practice.”

(Arch Ophthalmol. 2007;125:552-554.)

Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Rasik B. Vaypayee
JAMA and Archives Journals

Newly published clinical
research conducted among contact lens wearers demonstrates that daily-wear
silicone hydrogel contact lenses can improve comfort significantly versus
hydrogel lenses in most surroundings. The research also reveals that newer,
second-generation silicone hydrogels made from senofilcon A and galyfilcon
A can significantly reduce the frequency of commonly reported ocular
surface symptoms such as dryness and discomfort in adverse environments and
during visually demanding tasks, such as traveling by plane, driving at
night, using a computer, reading, and sitting in an air-conditioned or
heated car or building. The findings appear in the April issue of Optometry
and Vision Science, the peer-reviewed journal of the American Academy of
Optometry.

Nearly 500 contact lens wearers between the ages of 18 and 40
participated in the study, which was conducted at 48 clinical sites
throughout the United States. Participants’ subjective responses enabled
researchers to evaluate the frequency of use of contact lenses and the
associated comfort in 12 challenging environments while wearing hydrogel
lenses and then again after being refit with silicone hydrogel contacts.

More than 80 percent of participants reported wearing contact lenses
“always” or “frequently” during everyday tasks: while reading, sitting in
an air-conditioned or heated car, using a computer and while driving at
night. Less than 40 percent said they wore their contacts “always” or
“frequently” while riding in an airplane, at high altitudes, or while
napping or sleeping. Contact lens wearers reported dusty, polluted or smoky
environments as the least comfortable situations for contact lens wear.
However, after being refit with silicone hydrogel lenses, study
participants reported that many environments, particularly those in which
they reported the most discomfort with hydrogel lenses, no longer appeared
to pose such a challenge.

“Contact lens wearers frequently put up with environmentally-triggered
discomfort because they need to continue wearing lenses while working,
traveling, or in other situations,” explains study co-author Robin
Chalmers, O.D., F.A.A.O., an independent clinical researcher specializing
in contact lens epidemiology. “Left unmanaged, these exacerbating
conditions may compromise their ability to wear contacts comfortably
throughout the day. In this study, after being refit with newer types of
silicone hydrogel lenses, contact lens wearers reported significantly
improved comfort in most environments.”

About the Study

The purpose of the study was to measure the proportion of daily-wear
hydrogel contact lens wearers who wear lenses in challenging environments
and during visually demanding tasks, and to evaluate their resulting
comfort in those conditions. A second objective was to determine whether
refitting those wearers with newer types of silicone hydrogel lenses
affects lens comfort among subjects who wear lenses in these situations.

Baseline data were collected from 496 hydrogel soft lens wearers on the
frequency of use of contact lenses and the associated comfort in
challenging environments, including, but not limited to, air travel,
driving at night, using a computer, reading, and exposure to
air-conditioning or heater while driving or in a building.

Subjects were then randomized to be refit with one of three silicone
hydrogel lenses for daily wear use — senofilcon A (ACUVUE(R) OASYS(TM)
Brand Contact Lenses with HYDRACLEAR(TM) Plus, Vistakon(R) Division of
Johnson & Johnson Vision Care, Inc.; n=228), galyfilcon A (ACUVUE(R)
ADVANCE(TM) Brand Contact Lenses with HYDRACLEAR(TM),Vistakon(R); n=132),
or lotrafilcon B (O2 Optix(TM), Ciba Vision; n=136). Participants were
masked to their new lens type. After two weeks of silicone hydrogel lens
wear, comfort responses were compared for participants who “always” or
“frequently” used lenses in the queried environments. Study visits also
included routine, clinical examinations.

Participants who wore senofilcon A (ACUVUE OASYS) and galyfilcon A
(ACUVUE ADVANCE) reported significantly improved comfort in most
situations. Subjects who were fit with lotrafilcon B (O2 Optix), reported
fewer symptoms in many environments but did not report a significant
improvement in the most frequently experienced challenging environments;
night driving, computer use, or while sitting in a car with heat or
air-conditioning.

“Contact lens discomfort or dryness are most often cited as the reason
people stop wearing contact lenses,” says Dr. Chalmers. “The experience
with silicone hydrogel lenses in this study demonstrates why these lenses
are rapidly becoming the standard of care for soft lens wear.”

The study was sponsored by Vistakon(R), Division of Johnson & Johnson
Vision Care. Dr. Chalmers is a paid consultant for Vistakon, CIBA Vision
and other ophthalmic companies.

ACUVUE(R), Brand Contact Lenses are indicated for vision correction. As
with all contact lenses, eye problems, including corneal ulcers, can
develop. Some wearers may experience mild irritation, itching or
discomfort. Lenses should not be prescribed if patients have any eye
discomfort, excessive tearing, vision changes, redness or other eye
problems. Consult the package insert for complete information.

ACUVUE(R), ACUVUE(R) ADVANCE(TM), HYDRACLEAR(TM), ACUVUE(R) OASYS(TM),
and VISTAKON(R) are trademarks of Johnson & Johnson Vision Care, Inc.

Vistakon, Division of Johnson & Johnson Vision Care, Inc.
jnjvision

The Association for Research in Vision and Ophthalmology (ARVO) announced today that David R. Williams, PhD, has been
selected to receive the Friedenwald Award, which is presented annually for outstanding research in the basic or clinical
sciences as applied to ophthalmology. The award will be presented to Williams during ARVO’s 2006 Annual Meeting in Fort
Lauderdale, Fla., in May, 2006.

Williams was selected to receive the Friedenwald Award in recognition for his incomparable studies on human optics, human
cone receptors and color vision. He is also being recognized for his recent groundbreaking work on the application of
adaptive optics to human retinal imaging.

Williams is William G. Allyn Professor of Medical Optics and Director of the University of Rochester’s Center for Visual
Science. He has appointments in the University’s Departments of Brain and Cognitive Sciences, Optics, Ophthalmology, and
Biomedical Engineering. Williams received his doctorate in psychology from the University of California, San Diego. He holds
eight patents and has authored over 100 scientific publications.

Established in 1928, ARVO is a membership organization of more than 11,300 eye and vision researchers from over 70 countries.
The Association encourages and assists its members and others in research, training, publication and dissemination of
knowledge in vision and ophthalmology. ARVO’s headquarters are located in Rockville, Md. For more information about ARVO,
logon to the Association’s Web site, arvo.

Contact: Elinore Tibbetts
etibbettsarvo
240-221-2923
Association for Research in Vision and Ophthalmology
arvo

Recent automobile accidents with tragic results have prompted questions about the eyesight of elderly drivers, but researchers say they are unable to determine whether vision tests actually lead to fewer fatal crashes.

“We have this hypothesis that [as years pass] you have more age-related eye conditions,” said lead reviewer Sayed Subzwari. By this line of reasoning, elderly drivers are theoretically more accident-prone. However, the review found little evidence to make that case.

The new review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews like this one draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Subzwari, a family physician and researcher, led a team from the British Columbia Injury Research and Prevention Unit, Centre for Community Health Research in Vancouver, Canada. They screened more than 4,500 published and unpublished studies. However, none met the rigorous criteria that the researchers had set for review inclusion.

“Three relevant studies were identified, but they did not meet the predefined study design criteria,” Subzwari said.

Outside data suggest that advanced age does not necessarily translate into poor driving skills. In December, the Insurance Institute for Highway Safety reported that fewer older drivers died or were involved in fatal collisions from 1997 to 2006 than in past years.

Yet doctors, health advocates and family members routinely debate how long elderly drivers should stay on the road. A fast-growing proportion of the population is over 65. According to the U.S. Census Bureau, about 37 million Americans are currently in that age group.

The recital of letters and numbers from the Snellen Chart of Visual Acuity is a senior rite of passage at motor vehicle departments in many states. Still, Snellen charts are “not that sensitive,” Subzwari said, and someone with cataracts might pass the exam. In addition, elderly drivers might suffer other vision-related impairments. For example, the Snellen chart does not measure glare sensitivity, so different tests are required.

Jurisdictions struggle to understand vision issues involving older drivers, said Anne McCartt, senior vice president for research at the Insurance Institute for Highway Safety. “The problem with older drivers is that yes, there are age-related impairments that, on average, we experience when we get older, but there are a lot of differences [among elderly drivers] too.”

Some elderly drivers experience no vision problems and unlike past generations American families no longer live in one geographic area. Younger family members are not available to taxi grandparents about town. “Many older drivers rely on their driving to have mobility,” McCartt said. “It’s a significant thing to take someone’s license away. You want a process that is fair.”

Older drivers who want to stay behind the wheel can point to some statistics in their favor: A 2008 Insurance Institute report revealed that crash deaths among drivers 70 and older fell 21 percent from 1997 to 2006, even as the population in that age group rose 10 percent. Compared to drivers ages 35 to 54, the Institute found that older drivers experienced larger declines in fatal crash involvements.

“We’re not sure why older drivers are doing better,” McCartt said. However, she added that older drivers are less likely to be in alcohol-related crashes. “They don’t talk on the phone to the same extent [as younger drivers].” Few elderly drivers steer while sending text messages, she said. “My parents don’t know what text messaging is.”

Compared to drivers between the ages of 20 and 69, fewer people 70 and older have a license to drive. They drive fewer miles per licensed driver, according to the Insurance Institute. Researchers point out that older drivers have a lower crash rate because they simply do not get behind the wheel as often.

In addition, some states allow mail-in license renewals. When required to come into the motor vehicle department to take an eye exam, some elderly drivers opt out in fear of failing.

“They self-regulate,” said Ediriweera Desapriya, a researcher with the BC Injury Research and Prevention Unit. Many of the elderly are selective about their trips, driving only when required. “They go to the doctor’s appointment and come back home.”

Still, considering the growing proportion of elderly drivers, the Canadian researchers propose a study using randomized selection to assess whether vision screening can effectively result in fewer crashes.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit cochrane for more information.

Subzwari S, et al. Vision screening of older drivers for preventing road traffic injuries and fatalities. (Review). Cochrane Database of Systematic Reviews 2009, Issue 1.

Health Behavior News Service
Center for the Advancement of Health, 2000 Florida Ave. NW, Ste. 210
Washington
DC 20009
United States
hbns

Quark Pharmaceuticals, Inc., a
development-stage pharmaceutical company discovering and developing novel
RNA interference (RNAi)-based therapeutics, today announced that its
partner, Pfizer Inc, initiated patient dosing in a Phase II trial
evaluating

PF-4523655 (RTP801i-14) in patients with diabetic macular edema (DME).

PF-4523655 is a novel siRNA drug candidate being co-developed by Quark
and Pfizer. As part of the companies’ Global Licensing Agreement, the
successful commencement of the trial triggers a milestone payment to Quark
from Pfizer, a small percentage of which is payable by Quark to Silence
Therapeutics and Alnylam as technology license milestone payments.

The Phase II prospective, randomized, dose-ranging study is evaluating
the safety and efficacy of PF-4523655 versus laser therapy in 160 DME
patients at multiple centers worldwide. PF-4523655 was designed to inhibit
Quark’s proprietary target RTP801, a gene involved in abnormal blood vessel
development and leakage in the eye. Under the companies’ Global Licensing
Agreement, Pfizer has exclusive development rights to siRNA-mediated
therapies that inhibit RTP801 for ophthalmic and non-ophthalmic
indications, while Quark is eligible for development and sales based
milestone payments.

Elena Feinstein, Chief Scientific Officer of Quark, commented, “By
targeting the RTP801 gene, PF-4523655 is differentiated from other
therapeutics for the same ophthalmic indications. While many competitors
target VEGF and its receptors, PF-4523655 inhibits abnormal blood vessel
growth and leakage independently of the VEGF pathway, reduces inflammation
and suppresses apoptosis.

PF-4523655 is a siRNA therapeutic candidate with the potential to be
efficacious when used as a monotherapy and in combination with existing
VEGF-based therapies.”

Shai Erlich, Chief Development Officer of Quark, commented, “The
progression of PF-4523655 into Phase II further supports our integrated
RNAi approach that leverages our internal BiFAR target discovery platform.
In addition, Pfizer’s interest demonstrates the viability of RTP801 as a
potential target for ophthalmic indications. We look forward to continuing
our relationship with Pfizer throughout later stages of clinical
development and intend to fully collaborate towards the potential
commercialization of PF-4523655 in diabetic macular edema, age-related
macular degeneration, and other ophthalmic indications covered in our
agreement.”

Dario Paggiarino, Executive Director Clinical Development of Pfizer
Inc, stated, “Our collaboration with Quark is a prime example of Pfizer’s
commitment to the research and development of innovative therapies with the
potential to preserve sight and improve patient outcomes in ophthalmology.
This research is important because not all patients with retinal disease
benefit from currently available treatments.”

Results from a Phase I/II trial completed by Quark on Pfizer’s behalf
showed that PF-4523655 was safe and well tolerated in patients with wet
age-related macular degeneration (wet-AMD) who failed to respond to
currently approved therapies. Based on data from this trial, Pfizer decided
to pursue a Phase II trial in DME. In addition, Quark and Pfizer are
considering an additional Phase II study of PF-4523655 in patients with
wet-AMD.

About the PF-4523655 (RTP801i-14) Clinical Program

PF-4523655 (RTP801i-14) is a synthetic, siRNA molecule designed to
inhibit the expression of Quark’s proprietary target, RTP801. The product
candidate is licensed to Pfizer on an exclusive worldwide basis. Quark
discovered RTP801 using its BiFAR target discovery platform, which
identifies clinically relevant critical genes and proteins that reverse the
disease phenotype when inhibited. The Company owns a family of patents
covering the RTP801 gene, its RNA and protein product sequences, specific
antibodies, and gene inhibition across different pathologies.

The Phase II prospective, randomized, multi-center, dose ranging study
is designed to evaluate the efficacy and safety of PF-04523655 versus laser
therapy in 160 patients with DME. Eligible patients will be randomized to
receive intravitreal injections of one of three dose levels of PF-04523655
or laser. Therapeutic effect will be evaluated through visual acuity and
retina morphological examinations conducted over a 36-month follow up
period.

About Quark Pharmaceuticals, Inc.

Quark Pharmaceuticals, Inc. is a development-stage pharmaceutical
company engaged in discovering and developing novel therapeutic RNAi drug
candidates. Quark has a fully integrated drug development platform that
spans therapeutic target identification to drug development. Quark’s RNAi
technology includes novel siRNA structures and chemistry that the Company
believes provide Quark with freedom to operate in the siRNA intellectual
property arena, as well as the ability to deliver siRNA locally and
systemically to organs including the eye, ear, kidney, lung, spinal cord
and bone marrow.

PF-4523655 (RTP801i-14), currently in Phase II clinical trials, is a
synthetic, chemically modified, siRNA molecule to inhibit the expression of
the gene RTP801. In addition, Quark’s current clinical pipeline includes
AKIi-5, developed by Quark for the prevention of acute kidney injury (AKI)
following major cardiac surgery, currently in Phase I/IIa clinical trials
via systemic delivery. Based on publicly available information, Quark
believes this was the first siRNA delivered systemically in a human
clinical trial. The Company has structure related technology licenses from
Silence Therapeutics and from Alnylam.

In addition, Quark has a broad pipeline of siRNA drug candidates based
a novel structure developed internally. The Company expects to utilize the
structure to develop additional RNAi drug candidates without in-licensing
any structure-related technology patents.

Quark is headquartered in Fremont, California and operates research and
development facilities in Boulder, Colorado and Ness-Ziona, Israel.
Additional information is available at quarkpharma.

Quark Pharmaceuticals, Inc.
quarkpharma

At a reception in the European Parliament last night, the Vision=E3 Partnership called for a more united approach to the training and employment of blind and partially sighted people in the workplace. The Parliamentary reception brought together MEPs, Commission officials and NGOs, who discussed best practices and a list of positive actions that Europe can take to improve the current situation.

“By sharing experiences, comparing and contrasting the employment situations of blind and partially sighted people in the respective partner countries, the Vision=E3 partnership has arrived at common solutions for the future, and developed several common calls to action for politicians and NGOs”, said Andy Taylor, coordinator of the Vision=E3 Partnership. “I’m delighted to be here in the European Parliament with representatives to share what we have learned through this important and fruitful partnership”.

The Vision=E3 partnership recommendations for positive action focus on a number of areas, including Employment, ICT Training, Daily Living Skills, Training, eAccessibility, Enterprise Support as well as Social Assistance and Benefits.

Through this partnership, a number of reports have also been developed covering:

– Good practice on the range of models of integrated employment;
– Comparisons of partner training programmes;
– Recommendations for future practice;
– Recommendations on internet information systems,
– A statistical report on data of visually impaired people in the partner countries

About the Vision=E3 Partnership

Funded by the European Social Fund, the Vision=E?? partnership comprises various organisations across Europe:

– Visage (United Kingdom);
– Tyfloemploy (Czech Republic);

– Sizar (Slovakia);
– Partnership for improving access of the blind to the labour market (Poland);
– Per Linguas Mundi (Poland)

For more information on Vision=E3 Partnership, please visit
here.

visage-equal