Eylea HD injection of 8 gm in the Phase 3 trial (QUASAR trial) is meeting the primary endpoints showing improved vision with extended dosing intervals in patients with macular edema following Retinal Vein Occlusion. Safety data remains consistent with the known Eylea HD and Eylea safety profiles. The Supplementary biologics license application is planned for submission to the FDA in the first quarter of 2025.
EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks
Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles
Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025
TARRYTOWN, N.Y., Dec. 17, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA® (aflibercept) Injection 2 mg, the current standard of care. These data will be submitted to regulatory authorities around the world, with a submission to the U.S. Food and Drug Administration (FDA) planned for the first quarter of 2025, and are planned for presentation at an upcoming medical meeting.
“All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing, which can be burdensome for a patient. These impressive data from QUASAR demonstrated that EYLEA HD patients with retinal vein occlusion experienced improved vision with fewer injections than EYLEA – which could offer a significant advancement in this treatment setting,” said Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago. “Furthermore, about 90% of EYLEA HD patients were able to maintain 8-week dosing intervals through 36 weeks.”
QUASAR is a global, double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD, compared to EYLEA, in patients with RVO. EYLEA HD patients were treated with an 8-week dosing regimen (after 3 or 5 initial monthly doses), and EYLEA patients were treated every 4 weeks. The primary endpoint was met at 36 weeks, with both groups of EYLEA HD patients achieving non-inferior visual acuity gains compared to those receiving EYLEA. EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions……