Macular Degeneration Drug Achieves Goal in Clinical Trial

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Regeneron Pharmaceuticals Inc. in Tarrytown, New York and the German pharmaceutical company Bayer HealthCare said today that all regimens of their drug VEGF Trap-Eye (aflibercept ophthalmic solution) met their primary objectives in two separate Phase 3 clinical studies of patients with the neovascular form of age-related macular degeneration, often called wet AMD.

VEGF Trap-Eye is a human fusion protein, consisting of soluble vascular endothelial growth factor (VEGF) receptors 1 and 2, that binds all forms of VEGF-A along with the related placental growth factor.  VEGF Trap-Eye blocks all of these growth factors.  VEGF Trap-Eye is specially purified and concentrated to allow for injection into the eye.

In phase 3 trials, an experimental study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

The first study, with 1,217 randomized patients, is being conducted in the United States and Canada by Regeneron.  The second study, with 1,240 randomized patients, is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare.  The study designs are essentially identical.  The primary study objective measures, called endpoint, were conducted after 52 weeks. In each of the studies, VEGF Trap-Eye was evaluated for its effect on maintaining and improving vision when dosed as an injection into the eye on a schedule of 0.5mg monthly, 2mg monthly, or 2mg every two months (following three monthly loading doses), as compared with injected ranibizumab administered 0.5mg every month during the first year of the studies.

The primary endpoint of these is the proportion of patients treated with VEGF Trap-Eye who maintain visual acuity at the end of one year would do no worse on the end-point measures, compared to ranibizumab patients.  Visual acuity is 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 is defined as losing fewer than three lines — equivalent to 15 letters — on the ETDRS chart.

In the North American (Regeneron) 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 (Bayer HealthCare) 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.

In the Regeneron study, patients receiving VEGF Trap-Eye 2mg monthly achieved on average a statistically significant greater improvement in visual acuity at week 52 versus the baseline — the study’s secondary endpoint — compared to ranibizumab 0.5mg monthly. Patients receiving VEGF Trap-Eye 2mg monthly on average gained 10.9 letters, compared to an 8.1 letter gain with ranibizumab 0.5mg dosed every month.  All other dose groups of VEGF Trap-Eye in the study and all dose groups in the Bayer HealthCare study were not statistically different from ranibizumab on this secondary endpoint.

The companies say they found both VEGF Trap-Eye and ranibizumab in general to be safe for patients. The incidence of events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease, or the aging process.

Related: Trial Shows No Difference in Drugs for Macular Degeneration

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