Regeneron Pharmaceuticals (REGN) Reports Results from Phase 2 Study of VEGF Trap-Eye

September 29, 2008 9:10 AM EDT

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG announced that VEGF Trap-Eye achieved durable improvements in visual acuity and in biologic measures of neovascular disease, including retinal thickness and active choroidal neovascularization lesion size, for up to one year in a Phase 2 study in the neovascular form of Age-related Macular Degeneration.

In this double-masked Phase 2 trial, patients were initially treated with either fixed monthly or quarterly dosing for 12 weeks and then continued to receive treatment for another 40 weeks on a PRN (as needed) dosing schedule. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p less than 0.0001 versus baseline) and 5.4 letters (p less than 0.085 versus baseline), respectively, at the end of one year. 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.) increased from 23 percent at baseline to 45 percent at week 52 in patients initially treated with 2.0 mg monthly and from 16 percent at baseline to 47 percent at week 52 in patients initially treated with 0.5 mg monthly. During the week 12 to week 52 PRN dosing period, patients initially dosed on a 2.0 mg monthly schedule received, on average, only 1.6 additional injections and those initially dosed on a 0.5 mg monthly schedule received, on average, 2.5 injections.

Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for 12 weeks followed by PRN dosing also achieved mean decreases in retinal thickness versus baseline of 143 microns (p less than 0.0001 versus baseline) and 125 microns (p less than 0.0001 versus baseline) at week 52, respectively.

Regeneron Pharmaceuticals, Inc., a biopharmaceutical company, discovers and develops pharmaceutical products for the treatment of serious medical conditions in the United States.

Related Categories

Corporate News

Stocks Mentioned

Add Your Comment

Name

Subject

Body

Verification can't see the text?
click here to refresh the image.
what's this?