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Regeneron Pharmaceuticals announced at an ongoing Phase 2 trial has met its primary safety endpoint with no new safety signals observed.
Regeneron Pharmaceuticals Inc. announced that the ongoing Phase 2 proof-of-concept trial (NCT04126317) in which an 8-mg dose of aflibercept (Eylea) is being compared with a 2-mg dose for wet age-related macular degeneration (AMD), met the primary safety endpoint.
No new safety signals were observed compared to the approved 2-mg dose of the drug in 106 treatment-naïve patients with wet AMD (mean age, 77 years) randomly assigned to 1 of the 2 doses.
At the week-16 primary efficacy endpoint, the 8-mg dose resulted in 43.4% of patients having no retinal fluid compared with 26.4% treated with the 2-mg dose, a difference that trended toward significance (p = 0.067).
By 16 weeks, patients in both groups had received three initial doses at weeks 0, 4 and 8, after which dosing was extended to every 12 weeks or more frequently due to persistent/worsening disease.
Adverse events occurred in 17.0% of patients receiving the 8-mg dose and 22.6% receiving the 2-mg dose.
One serious ocular adverse event occurred in each group, i.e., a retinal tear in the 8-mg group and decreased vision in the 2-mg group.
No intraocular inflammation or arterial thromboembolic events or deaths occurred in either group.
The company expressed cautious optimism that the 8-mg dose of aflibercept will benefit patients with wet AMD.
Aflibercept is also being evaluated in 2 Phase 3 clinical trials for treating diabetic macular edema (PHOTON trial) and wet AMD (PULSAR trial). Both trials will assess the 8-mg dose of aflibercept compared to the 2-mg dose and test dosing intervals of every 12 weeks and every 16 weeks.
The Phase 3 studies are expected to announce results in the second half of 2022.