FDA Greenlights Higher-Dose Aflibercept for Retinal Vein Occlusion Edema
The U.S. Food and Drug Governance (FDA) approved Regeneron’s Eylea HDR (aflibercept) injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) on June 7, 2024. This approval introduces a higher-dose formulation of aflibercept,offering a perhaps less frequent treatment regimen for a vision-threatening condition.
RVO, a blockage in the veins that drain blood from the retina, is a leading cause of vision loss in adults. Macular edema, swelling in the central part of the retina, frequently develops as an inevitable result, severely impacting sight.The approval of Eylea HDR provides a new option for the approximately 1.6 million americans affected by RVO, potentially reducing the burden of frequent eye injections and improving visual outcomes.
The approval is based on data from the Phase 3 PANORAMA trial, which demonstrated that Eylea HDR met its primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) at 52 weeks compared to Eylea (aflibercept) 2 mg. Notably,a critically important proportion of patients treated with the higher dose required no further injections from week 36 to 52.
Safety data from PANORAMA were consistent with the known safety profile of aflibercept. Common side effects include eye pain, conjunctival hemorrhage, increased intraocular pressure, and cataract.
Regeneron is also conducting the QUASAR study (NCT05850520) to evaluate the efficacy and safety of a higher amount of aflibercept in patients with reduced vision due to macular edema caused by a blocked vein in the retina. Further details on the PANORAMA trial are available in a news release from Regeneron, published June 7, 2024. (https://newsroom.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary) Clinical trial information for QUASAR can be found on ClinicalTrials.gov (https://clinicaltrials.gov/study/nct05850520).
