FDA Sets The Countdown: Regeneron's Eylea HD Could Be Headed For Major Expansion

The U.S. Food and Drug Administration has accepted for Priority Review Regeneron Pharmaceuticals, Inc.’s (NASDAQ:REGN) supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8 mg.

The sBLA seeks approval for Eylea HD for macular edema following retinal vein occlusion (RVO) and broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications.

The FDA target action date is August 19, 2025, following the use of a Priority Review voucher.

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Data from the Eylea HD clinical program, including the Phase 3 QUASAR trial investigating Eylea HD in RVO, support the sBLA.

As previously presented, QUASAR met its primary endpoint at 36 weeks. Eylea HD patients were dosed every 8 weeks (after 3 or 5 monthly doses), achieving non-inferior visual acuity gains compared to those receiving Eylea (aflibercept) Injection 2 mg dosed every 4 weeks.

All anti-VEGF therapies approved to treat RVO, including Eylea, are indicated for monthly dosing.

In QUASAR, the safety profile of EYLEA HD (n=591) was similar to Eylea (n=301). It remained generally consistent with the known safety profile of Eylea HD in its pivotal trials for approved indications and with the established safety profile of Eylea.

Increased ocular pressure (5%) was the only ocular treatment-emergent adverse event that occurred in ≥5% of all Eylea HD patients, compared to 1.7% of Eylea patients.

There was one case each of endophthalmitis and retinal vasculitis in all Eylea HD patients, compared to two cases of endophthalmitis and no cases of retinal vasculitis in Eylea patients.

No cases of occlusive retinal vasculitis were reported. The rate of intraocular inflammation was 0.5% for Eylea HD and 1.3% for Eylea.

The safety and efficacy of Eylea HD for RVO and monthly dosing in approved indications have not been evaluated by any regulatory authority.

B of A Securities maintains Regeneron Pharmaceuticals with an Underperform and lowers the price target from $575 to $547.

Price Action: REGN stock is up 1.3% at $556.48 at the last check Thursday.

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