Regeneron Pharmaceuticals, Inc and Bayer HealthCare AG has announced the result of Phase 2 trial of the VEGF Trap-Eye. It reported to have achieved durable improvements in visual acuity and in biologic measures of neovascular disease, including retinal thickness and active choroidal neovascularization lesion size.
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.
At the end of the study, the 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.
Filed under Eye Treatment, Improved Vision | Tags: Bayer HealthCare AG, double-masked Phase 2 trial, neovascular disease, Regeneron Pharmaceuticals Inc, retinal thickness, VEGF Trap-Eye, visual acuity | Comment Below