Regeneron's phase 1 study of VEGF in wet AMD meets primary endpoints of safety, tolerability

By Lisa Kerner

Erie, Pa., May 1 - Regeneron Pharmaceuticals, Inc.'s phase 1 trial of the Vascular Endothelial Growth Factor (VEGF) Trap in patients with the neovascular form of age-related macular degeneration (wet AMD) met its primary endpoints of safety and tolerability at all dose levels.

In addition, the VEGF Trap demonstrated positive preliminary efficacy results, according to a company news release.

In the study, a total of 21 patients with wet AMD received a single intravitreal injection of 0.05 mg, 0.15 mg, 0.5 mg, 1, 2 mg or 4 mg of VEGF Trap and followed for 6 weeks.

Of the 20 patients evaluable for efficacy, 95% had stabilization or improvement in visual acuity, defined as less than or equal to 15 letter loss on the Early Treatment of Diabetic Retinopathy Study eye chart, the company said.

The mean improvement in best corrected visual acuity (BCVA) was 13.5 letters in the two highest dose groups, with three of six patients gaining 15 or more letters.

"We are very encouraged both by the promising safety and tolerability data from this trial and by the observed improvements in both retinal swelling and visual acuity in patients following a single dose of this very high-affinity VEGF blocking agent," Regeneron Research Laboratories' president George Yancopoulos said in the release.

"With the start of the phase 2 trial, we hope to validate these early, preliminary findings in a more comprehensive study, determine an optimal dosing regimen, and progress rapidly to registration studies for the VEGF Trap in wet AMD."

VEGF, a naturally occurring protein in the body, normally triggers formation of new blood vessels but has been linked to the abnormal growth and fragility of new blood vessels in the eye.

Data from the phase 1 trial were presented at the 2006 Association for Research in Vision and Ophthalmology Annual Meeting.

Regeneron is a biopharmaceutical company located in Tarrytown, N.Y.

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