VEGF TRAP-EYE E OCLUSAO VENOSA
VEGF Trap-Eye (Eylea) for macular oedema secondary to central retinal vein occlusion – first line
VEGF Trap-Eye: An Emerging Treatment for Wet AMD
VEGF Trap-Eye is a promising treatment that could offer patients another option in the fight against macular degeneration.
In February 2011, AMD Alliance International offered its organizational members around the world a unique opportunity to hear directly, via webcast, from lead researchers of the View 1 and View 2 studies investigating VEGF Trap-Eye.
Dr. Ursula Schmidt-Erfurth, View Study Primary Investigator and Professor and Chair of the Department of Ophthalmology of the University Eye Hospital of Vienna answered questions during the hour long session. Dr. Todd Katz, a retina specialist and senior physician in the Global Medical Affairs Department of Bayer, and Dr. Beate Stych, Vice President and Head of Medical Affairs of Regeneron Pharmaceuticals also presented key information. AMDAI’s Executive Board Member, Dr. Keith Gordon, Vice-President, Research and Service Quality at CNIB, moderated the webcast. More than 20 organizations from around the globe participated in this important informational session.
Below are some of the questions asked about this emerging treatment.
Q1: What Is VEGF Trap-Eye?
A1: Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body that has been associated with the abnormal growth of new fragile blood vessels in the back of the eye, vascular permeability and the formation of edema. VEGF Trap-Eye is a VEGF receptor fusion protein that binds all forms of VEGF-A along with placental growth factor (PlGF), another member of the VEGF family also believed to be implicated in the development of wet age-related macular degeneration (AMD).
Q2: How does VEGF Trap-Eye work?
A2: VEGF Trap-Eye is an investigational highly potent blocker of VEGF-A and PlGF that has been demonstrated to bind growth factors with greater affinity than their natural receptors.
Q3: What does VEGF Trap-Eye treat?
A3: In clinical studies, VEGF Trap-Eye has been shown to improve vision in patients living with wet AMD, diabetic macular edema (DME), central retinal vein occlusion (CRVO), and other eye diseases and disorders.
Q4: What companies manufacture VEGF Trap-Eye?
A4: Bayer Schering Pharma and Regeneron are collaborating on the global development of VEGF Trap-Eye.
Q5: Why is VEGF Trap-Eye being developed?
A5: Clinical studies have shown that VEGF Trap-Eye may be effective in treating wet AMD in those living with the condition.
About the View studies
In both studies, named VIEW 1 and View 2, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed every two months, achieved primary endpoint compared to ranibizumab dosed every month.
In the North American VIEW 1 study, 96 percent of patients receiving VEGF Trap-Eye 0.5mg monthly, 95 percent of patients receiving VEGF Trap-Eye 2mg monthly, and 95 percent of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision compared to 94 percent of patients receiving ranibizumab 0.5mg dosed every month. In the international VIEW 2 study, 96 percent of patients receiving VEGF Trap-Eye 0.5mg monthly, 96 percent of patients receiving VEGF Trap-Eye 2mg monthly, and 96 percent of patients receiving VEGF Trap-Eye 2mg every two months achieved maintenance of vision compared to 94 percent of patients receiving ranibizumab 0.5mg dosed every month. Visual acuity was measured as a score based on the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity, over 52 weeks. Maintenance of vision was defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS eye chart.
“In an effort to avoid the inconvenience of monthly office visits and the burden of monthly injections into the eye for their wet AMD patients, retinal specialists have tried to extend the benefits of the existing anti-VEGF therapy with less frequent dosing. A growing body of data suggests that this practice may result in inconsistent visual acuity outcomes,” said Jeffrey Heier, M.D., a clinical ophthalmologist and retinal specialist at Ophthalmic Consultants of Boston, Assistant Professor of ophthalmology at Tufts School of Medicine, and Chair of the Steering Committee for the VIEW 1 trial. “A critical goal of these studies was to demonstrate that VEGF Trap-Eye could achieve robust improvements in vision and maintain them over time with a more convenient every-other-month dose. Achievement of this goal could be important for patients, care givers, and physicians.”
In the VIEW 1 study, patients receiving VEGF Trap-Eye 2mg monthly achieved a statistically significant greater mean improvement in visual acuity at week 52 versus baseline (secondary endpoint), compared to ranibizumab 0.5mg monthly; patients receiving VEGF Trap-Eye 2mg monthly on average gained 10.9 letters, compared to a mean 8.1 letter gain with ranibizumab 0.5mg dosed every month (p<0.01). All other dose groups of VEGF Trap-Eye in the VIEW 1 study and all dose groups in the VIEW 2 study were not statistically different from ranibizumab in this secondary endpoint.
A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The incidence of ocular treatment emergent adverse events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease, and/or the aging process. The most frequent ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters. The most frequent serious non-ocular adverse events were typical of those reported in this elderly population who receive intravitreal treatment for wet AMD; the most frequently reported events were falls, pneumonia, myocardial infarction, atrial fibrillation, breast cancer, and acute coronary syndrome. There were no notable differences among the study arms.
In the second year of the studies, patients in VIEW 1 and VIEW 2 will continue to be treated with the same dose per injection as in the first year but administered only every three months, or more often for any worsening of AMD, based on protocol-defined criteria (called "quarterly capped PRN" dosing).
Q6: What was the design of the View studies?
A6: The VIEW program consists of two randomized, double-masked, Phase III clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD). The VIEW 1 study is being conducted in the United States and Canada and the VIEW 2 study is being conducted in Europe, Asia-Pacific, Japan, and Latin America.
In each of the studies, VEGF Trap-Eye is being evaluated for its effect on maintaining and improving vision as compared with Lucentis® (ranibizumab). The primary endpoint of studies is the proportion of patients treated with VEGF Trap-Eye who maintain vision at the end of one year, compared to patients taking Lucentis. Key secondary endpoints include the mean change from baseline in visual acuity as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) and the proportion of patients who gained at least 15 letters of vision at week 52. Visual acuity is defined as the total number of letters read correctly on the ETDRS chart. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS chart. These studies are part of the global development program for VEGF Trap-Eye being conducted by Regeneron and Bayer HealthCare AG and represent the largest clinical trial program to date in wet AMD.
Q7: How is VEGF Trap-Eye administered?
A7: VEGF Trap-Eye, used for the treatment of wet AMD, is administered through injections into the eye.
Q8: What are the side effects of VEGF Trap-Eye?
A8: Data from the Phase II study show that VEGF Trap-Eye is generally well tolerated, and there have been no serious drug-related adverse events. During the Phase II studies, the most common side effects were typically associated with the injections. Safety data from the Phase III studies is still under review.
Q9: When will VEGF Trap-Eye be reviewed by regulatory authorities?
A9: Data from the View 1 and View 2 Phase III trials are currently under review.
AMD Alliance International is committed to providing patients with the latest information as soon as it becomes available. Check back with us for regular updates on this promising new treatment.
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Outros: NEWS: EYLEA(TM) VEGF Trap-Eye Receives Unanimous Recommendation for Approval for Treatment of Wet AMD from FDA Advisory Committee
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Regeneron Pharmaceuticals, Inc. announced that the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted unanimously to recommend that the FDA approve EYLEA™ ((aflibercept ophthalmic solution), also known as VEGF Trap-Eye, for the treatment of the neovascular form of age-related macular degeneration (wet AMD) at a dose of 2 milligrams (mg) every eight weeks, following three initial doses given every four weeks.
The committee's recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for EYLEA, but the committee's recommendation is not binding on the FDA. Regeneron submitted a BLA for marketing approval in wet AMD in the U.S. in February 2011 and received a Priority Review designation. Under Priority Review, the target date for an FDA decision on the EYLEA BLA is August 20, 2011.
Bayer HealthCare submitted an application for marketing authorization in Europe in wet AMD in June 2011 and will market EYLEA™ outside the United States.