- Regeneron Pharmaceuticals' (REGN, Financial) EYLEA HD® (aflibercept) Injection 8 mg has received FDA Priority Review status for a supplemental Biologics License Application (sBLA).
- The FDA's target action date for this application is August 19, 2025, potentially accelerating market entry for EYLEA HD.
- The QUASAR Phase 3 trial demonstrated non-inferior efficacy of 8-week dosing compared to standard monthly EYLEA 2 mg dosing.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for EYLEA HD® (aflibercept) Injection 8 mg for Priority Review. The application includes treatment for macular edema following retinal vein occlusion (RVO) and extends dosing options to allow monthly intervals across all approved indications.
If successful, EYLEA HD could become the first treatment offering 8-week dosing for RVO after initial monthly doses, effectively halving the injection frequency compared to current anti-VEGF therapies. This development promises to significantly reduce the treatment burden on patients while maintaining non-inferior visual acuity.
The FDA's target date to take action on the application is August 19, 2025. The announcement is supported by results from the Phase 3 QUASAR trial, which demonstrated comparable efficacy of EYLEA HD's less frequent dosing to the monthly standard, providing robust evidence towards achieving approval.
Despite a similar safety profile to existing EYLEA formulations, the trial noted an increased rate of ocular pressure as a side effect in EYLEA HD patients (5% compared to 1.7% with standard EYLEA). However, the data indicated favorable tolerability with respect to intraocular inflammation and adverse event rates.
By potentially enhancing the flexibility and reducing the frequency of dosing, EYLEA HD aims to improve the quality of life for patients, particularly those who face challenges with frequent healthcare visits. Regeneron is committed to advancing eye care treatments, and this expanded indication could fortify its position in the ophthalmology market.
