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VEGF Trap-Eye maintains benefits in AMD patients over extended trial period
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TARRYTOWN, N.Y. — In a phase 2 extension trial of VEGF Trap-Eye, the agent significantly reduced retinal thickness and improved visual acuity among patients with wet age-related macular degeneration, according to a joint press release from co-developers Regeneron Pharmaceuticals and Bayer HealthCare.
In the double-masked, prospective, multicenter study, 157 patients were randomly assigned to five dosing groups and treated with the drug in one eye. Initially, two groups received monthly doses of 0.5 mg or 2 mg of VEGF Trap-Eye at baseline and 4, 8 and 12 weeks, and three groups received quarterly doses of 0.5 mg, 2 mg or 4 mg of VEGF Trap-Eye at baseline and at week 12.
After the initial fixed-dosing phase of the trial, patients continued to receive therapy at the same dose on an as-needed basis.
Patients who received four monthly doses of VEGF Trap-Eye in either 2-mg or 0.5-mg concentrations achieved a mean visual acuity improvement of 9 letters (P < .0001) and 5.4 letters (P =.085), respectively, at week 52. The 2-mg and 0.5-mg doses also achieved mean decreases in retinal thickness of 143 µm (P < .0001) and 125 µm (P < .0001), respectively. During the subsequent as-needed dosing phase, patients who initially received 2-mg doses received a mean of 1.6 additional injections and patients who initially received 0.5-mg doses received a mean of 2.5 additional injections, the release said.
For all dosing groups combined, there was a 5.3 mean letter gain in visual acuity at 52-week follow-up (P < .0001). Overall, the mean decrease in retinal thickness at 52 weeks was 130 µm (P < .0001). During the as-needed dosing period, patients from all dosing groups combined received a mean of two additional injections, according to the release.
VEGF Trap-Eye was well-tolerated and there were no serious drug-related adverse events.
An analysis of the 52-week results of the phase 2 study is expected to be presented at the Retina Society meeting in September, according to the release.