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Regeneron’s EYLEA HD® Achieves Key Endpoint In Phase 3 Trial For Retinal Vein Occlusion Treatment

Regeneron's QUASAR trial shows EYLEA HD® 8 mg improves vision in RVO with extended 8-week dosing.

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  • Dec 18, 2024

  • Simantini Singh Deo

Regeneron’s EYLEA HD® Achieves Key Endpoint In Phase 3 Trial For Retinal Vein Occlusion Treatment

Regeneron Pharmaceuticals, Inc.,  announced that its Phase 3 QUASAR trial evaluating EYLEA HD® (aflibercept) Injection 8 mg for treating macular edema following retinal vein occlusion (RVO) has met its primary endpoint. The study included patients with central, branch, and hemiretinal vein occlusions. EYLEA HD, administered every 8 weeks after initial monthly doses, demonstrated non-inferior improvements in vision compared to the approved monthly dosing regimen of EYLEA® (aflibercept) Injection 2 mg, the current standard of care.

“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. Furthermore, about 90% of EYLEA HD patients were able to maintain 8-week dosing intervals through 36 weeks,” said Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago.

Regeneron plans to submit these findings to regulatory authorities worldwide, including the U.S. FDA in the first quarter of 2025, with results to be presented at an upcoming medical conference. QUASAR, a global, double-masked, active-controlled trial, assessed EYLEA HD’s safety and efficacy against EYLEA in patients with RVO. At 36 weeks, both EYLEA HD and EYLEA achieved comparable visual acuity gains. The positive outcomes were consistent across patients with central, branch, or hemiretinal vein occlusions.

George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of EYLEA, stated, “With these pivotal results in retinal vein occlusion, EYLEA HD with extended dosing has again met the high bar of vision gains and safety seen with standard-of-care EYLEA. EYLEA HD has already made a significant impact on the treatment of its three approved indications – wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy – and now has the potential to substantially reduce the treatment burden for patients with retinal vein occlusion. We look forward to sharing these results with regulatory authorities around the world as soon as possible.”

EYLEA HD, also marketed as Eylea™ 8 mg in Europe and Japan, is being co-developed by Regeneron and Bayer AG. Regeneron retains exclusive rights to EYLEA and EYLEA HD in the U.S., while Bayer holds exclusive marketing rights outside the U.S., sharing profits equally with Regeneron. It’s important to note that regulatory authorities have not yet reviewed the safety and efficacy of EYLEA HD for RVO treatment.

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