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VEGF Trap-Eye Noninferior to Ranibizumab in Two Phase 3 Trials

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In patients with wet age-related macular degeneration (AMD), all regimens of aflibercept (VEGF Trap- Eye, Regeneron), including aflibercept dosed every 2 months, achieved the primary endpoint compared with ranibizumab (Lucentis, Genentech) dosed every month, according to the results of two parallel phase 3 studies reported in a news release. The primary endpoint was statistical noninferiority in the proportion of patients treated with aflibercept who maintained or improved visual acuity over 52 weeks compared with patients treated with ranibizumab.

The North American Regeneron-sponsored VIEW 1 study and the international Bayer HealthCare-sponsored VIEW 2 study are randomized, double-masked phase 3 clinical trials evaluating aflibercept for the treatment of wet AMD. The purpose of both studies is to determine the effects of aflibercept on maintaining and improving vision when dosed as an intravitreal injection, 0.5 mg monthly, 2.0 mg monthly, or 2.0 mg every 2 months (following three monthly loading doses), as compared with 0.5 mg ranibizumab dosed every month during year 1. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the Early Treatment Diabetic Retinopathy Study chart.

In VIEW 1, 96% of patients receiving aflibercept 0.5 mg monthly, 95% of patients receiving aflibercept 2.0 mg monthly, and 95% of patients receiving aflibercept 2.0 mg every 2 months achieved maintenance of vision compared with 94% of patients receiving ranibizumab 0.5 mg every month. In VIEW 2, 96% of patients receiving aflibercept 0.5 mg monthly, 96% of patients receiving aflibercept 2.0 mg monthly, and 96% of patients receiving aflibercept 2.0 mg every 2 months achieved maintenance of vision compared with 94% of patients receiving ranibizumab 0.5 mg every month.

In the VIEW 1 study, patients receiving aflibercept 2.0 mg monthly achieved a greater mean improvement in visual acuity (+10.9 letters) at week 52 compared with patients receiving ranibizumab 0.5 mg monthly (+8.1).

β€œIn 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,” Jeffrey Heier, MD, of the Ophthalmic Consultants of Boston and Tufts School of Medicine, and chair of the steering committee for the VIEW 1 trial, said in a news release. β€œA growing body of data suggests that this practice may result in inconsistent visual acuity outcomes. 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 year 2 of the studies, patients in VIEW 1 and VIEW 2 will continue to be treated with the same dose per injection as in year 1, but doses will be administered only every 3 months (or more often for any worsening of AMD), the news release said. According to the companies, further results are expected to be presented at the Angiogenesis Conference in February 2011.

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