No new safety signals reported with aflibercept 8 mg in patients with wet AMD
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A phase 2 trial investigating an 8 mg dose of aflibercept revealed no new safety signals compared with aflibercept 2 mg in patients with wet age-related macular degeneration, according to a press release from Regeneron Pharmaceuticals.
A higher proportion of patients who received the 8 mg dose of aflibercept in the proof-of-concept trial had no retinal fluid at week 16 compared with patients treated with currently approved Eylea (aflibercept 2 mg), 43.4% vs. 26.4%. The difference was not statistically significant.
In the first 16 weeks of the trial, adverse events occurred in 17% of patients receiving 8 mg injections and 22.6% of patients receiving 2 mg injections. Two serious adverse events occurred, with one retinal tear in the 8 mg group and one instance of reduced visual acuity in the 2 mg group.
“We are cautiously optimistic that these early data suggest that a higher dose of aflibercept may potentially benefit patients with wet AMD, and we look forward to phase 3 data next year, which will be crucial to understand its overall efficacy and safety,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the release.
Aflibercept 8 mg is also being investigated in two phase 3 trials in patients with diabetic macular edema and wet AMD. Results for those trials are expected in the second half of 2022.
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