Regeneron Announces Positive Phase 3 Results For EYLEA HD In Retinal Vein Occlusion Treatment
Regeneron Pharmaceuticals Inc. (REGN) has released promising results from the Phase 3 QUASAR trial, assessing the effectiveness of EYLEA HD (aflibercept) Injection 8 mg for addressing macular edema linked to retinal vein occlusion (RVO). This encompasses patients with central, branch, and hemiretinal vein occlusions. The findings from this trial will inform a supplemental Biologics License Application to the U.S. Food and Drug Administration, anticipated in the first quarter of 2025.
The QUASAR trial achieved its primary objective at 36 weeks, demonstrating that both EYLEA HD patient groups, dosed every eight weeks, attained non-inferior visual acuity improvements compared to those administered EYLEA (aflibercept) Injection 2 mg every four weeks.
The results for EYLEA HD were consistent among patients with branch, central, or hemiretinal retinal vein occlusions.
Additionally, among patients treated with EYLEA HD over 36 weeks, 88% were able to maintain an eight-week dosing schedule following three initial monthly doses, and 93% sustained the eight-week regimen after completing five initial monthly doses.
Regeneron highlighted that the safety profile of EYLEA HD was similar to that of EYLEA in the QUASAR study and largely aligned with the established safety profile from pivotal trials. Ocular treatment-emergent adverse events (TEAEs) occurring in 5% or more of all EYLEA HD patients included elevated intraocular pressure (5%). There was one incident each of endophthalmitis and retinal vasculitis. The intraocular inflammation rate was 0.5% for EYLEA HD and 1.3% for EYLEA.
EYLEA HD, referred to as Eylea 8 mg in the European Union and Japan, is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron retains exclusive rights to EYLEA and EYLEA HD, while Bayer holds the exclusive marketing rights outside the U.S., where the companies equally share profits from EYLEA and EYLEA HD sales.
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