FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion

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The FDA has granted Priority Review status to Regeneron’s and Bayer’s supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The application seeks to expand use of the treatment for patients with macular edema following retinal vein occlusion (RVO) to permit monthly dosing across all currently approved indications.¹

The sBLA is supported by data from the global, double-masked, active-controlled, Phase III QUASAR trial, which evaluated the efficacy and safety of Eylea in 892 patients with macular edema secondary to RVO, including central, branch, and hemiretinal vein occlusions. Patients were randomly assigned equally into three groups: Eylea HD every eight weeks following either three or five monthly lead-in doses, or Eylea 2 mg dosed every four weeks. The study’s primary endpoint was change in best corrected visual acuity (BCVA) at week 36, assessed by Early Treatment Diabetic Retinopathy Study letter score.^1,2

Results found that patients in the five-dose lead in regimen group demonstrated a mean BCVA improvement of 19.1 letters with a least squares mean difference in BCVA improvement non-inferiority p-value (p<0.0001) of 0.8. Additionally, 93% of patients in this group remained on the eight-week dose for the duration of the study. In the three-dose lead in regimen, patients demonstrated a mean BCVA improvement of 17 letters (p<0.0001) -0.1, with 88% of patients maintaining the eight-week dose.

Eylea HD’s safety profile was similar to that of Eylea and remained consistent with the treatment’s known safety profile. Treatment-emergent adverse events included increased ocular pressure, a reported case of endophthalmitis, and a reported case of retinal vasculitis. At baseline, hypertension was present in 66% of patients treated with Eylea HD and 62% of patients treated with Eylea. During the trial, 8.1% of patients treated with Eylea HD and 4.7% treated with Eylea had cases of hypertension. Thromboembolic events were also reported in 0.5% of Eylea HD patients and 1.7% of Eylea patients.²

According to a study published in the National Center for Biotechnology Information, the prevalence of macular edema is anywhere from 4.2% to 7.9% in patients with type 1 diabetes and 1.4% to 12.8% in patients with type 2 diabetes. Within nine years of disease onset, approximately 27% of patients with type 1 diabetes will develop macular edema.

In terms of RVO, prevalence varies depending on the type of RVO. The prevalence of central RVO ranges from 0.1% to 0.2% of the global population, while branch RVO affects anywhere from 0.5% to 2% of the population.³

“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,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, principal inventor of Eylea, in a December 2024 press release. “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.”²

The FDA has set a targeted action date of August 19, 2025.¹

References

1. EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications. Regeneron. April 17, 2025. Accessed April 18, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-sbla-accepted-fda-priority

2. EYLEA HD® (aflibercept) Injection 8 mg Phase 3 Trial Meets Primary Endpoint Showing Improved Vision with Extended Dosing Intervals in Patients with Macular Edema following Retinal Vein Occlusion. Regeneron. December 17, 2024. Accessed April 18, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary

3. Macular Edema. NIH. Accessed April 18, 2025. https://www.ncbi.nlm.nih.gov/books/NBK576396/#:~:text=%5B13%5D%20Its%20occurrence%20in%20population,those%20with%20type%202%20diabetes.