Phase II data of VEGF drug show positive results for wet AMD

Tarrytown, NY-Bayer HealthCare AG and Regeneron Pharmaceuticals Inc. have released positive early data from an interim analysis of a phase II randomized study of a vascular endothelial growth factor (VEGF) drug (Trap-Eye) in patients with the neovascular form of age-related macular degeneration (wet AMD).

The primary endpoint-statistically significant reduction in retinal thickness after 12 weeks compared with baseline-was met (p <0.0001). A secondary endpoint-mean change from baseline in visual acuity-also showed statistically significant improvement (p <0.0001). Patients who received just one dose, on average, experienced decreased excess retinal thickness (p <0.0001) and increased visual acuity (p = 0.012) at 12 weeks. No significant drug-related adverse events were reported. Overall treatment with the drug was well-tolerated.

The phase II study enrolled 150 patients randomly assigned to five groups and receiving the treatment in one eye. Patients in two groups received 0.5 or 2 mg of the drug, given every 4 weeks; patients in three groups were given one dose of 0.5, 2, or 4 mg of the drug. Patients were checked for safety, retinal thickness, and visual acuity.

The interim analysis of phase II involved the first 78 patients who completed 12 weeks of study. All but one patient had sustained or improved vision after 12 weeks.

“Importantly, the [drug] may offer the potential to improve vision in patients with wet AMD with dosing less frequently than every 4 weeks,” said George D. Yancopoulos, MD, PhD, president of Regeneron Research Laboratories. “Our phase III program is being designed to test this possibility and further evaluate the safety and efficacy of various doses and dosing intervals of the [drug].”

Bayer officials said they were “very pleased” with the outcome thus far and are encouraged to “foster next steps in the development” and future study of the drug in more eye diseases.

Phase III of the trial will begin in the second half of this year.