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Positive interim phase 2 data reported for VEGF Trap-Eye

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TARRYTOWN, N.Y. — An interim analysis of data from a phase 2 study of VEGF Trap-Eye found that the drug significantly improved retinal thickness in patients with neovascular age-related macular degeneration, according to a press release from Regeneron Pharmaceuticals and Bayer HealthCare.

At 12 weeks' follow-up, VEGF Trap-Eye led to a statistically significant mean decrease in retinal thickness of 135 µm compared with baseline, meeting the study's primary endpoint. In addition, visual acuity improved an average of 5.9 letters (P < .0001), the release said.

The phase 2 study involves 150 patients randomly assigned to one of five treatment groups. Two groups received either 0.5 mg or 2 mg intravitreal injections of VEGF Trap-Eye every 4 weeks, and three groups received a single dose of either 0.5 mg, 2 mg or 4 mg.

The interim analysis involved data for the first 78 patients who completed 12 weeks' follow-up. Investigators reported no serious drug-related adverse events, and treatment was generally well tolerated by patients, the release said.

Based on the results, Regeneron and Bayer HealthCare plan to initiate phase 3 drug development during the second half of this year.

Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye for treating exudative AMD and other ocular diseases and disorders. Both companies plan to jointly market the drug outside the United States, although Regeneron retains exclusive U.S. marketing rights.