Regeneron Pharmaceuticals, Inc. Announces Positive Primary Endpoint Results from a Phase 2 Study of VEGF Trap-Eye in Age-related Macular Degeneration

TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and development partner, Bayer HealthCare AG (NYSE:BAY) of Leverkusen, Germany, today announced positive results from the full analysis of the primary 12-week endpoint of a Phase 2 study evaluating the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The VEGF Trap-Eye met the primary study endpoint of a statistically significant reduction in retinal thickness, a measure of disease activity, after 12 weeks of treatment compared with baseline (all five dose groups combined, mean decrease of 119 microns, p<0.0001). The mean change from baseline in visual acuity, a key secondary endpoint of the study, also demonstrated statistically significant improvement (all groups combined, increase of 5.7 letters, p<0.0001). Preliminary analyses at 16 weeks showed that the VEGF Trap-Eye, dosed monthly, achieved a mean gain in visual acuity of 9.3 to 10 letters (for the 0.5 and 2 mg dose groups, respectively). In additional exploratory analyses, the VEGF Trap-Eye, dosed monthly, reduced the proportion of patients with vision of 20/200 or worse (a generally accepted definition for legal blindness) from 14.3 percent at baseline to 1.6 percent at week 16; the proportion of patients with vision of 20/40 or better (part of the legal minimum requirement for an unrestricted driver’s license in the U.S.) was likewise increased from 19.0 percent at baseline to 49.2 percent at 16 weeks. These findings were presented at the Retina Society Conference in Boston, MA. The data reported at the meeting are available on the Regeneron website (www.regeneron.com on the Events Page, under the Investor Relations heading).

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