FDA Accepts Regeneron’s sBLA for EYLEA HD for Priority Review

The U.S. Food and Drug Administration (FDA) has accepted Regeneron’s supplemental Biologics License Application (sBLA) for high-dose aflibercept (EYLEA® HD) for priority review, potentially expanding its use in the treatment of macular edema following retinal vein occlusion (RVO) and modifying its dosing schedule across approved indications.

Expanded Dosing and New Indication Proposed

The sBLA proposes two major updates:

       • Approval of EYLEA HD for macular edema due to RVO

       • Addition of an every-4-week (monthly) dosing schedule across approved indications

The FDA’s target action date is August 19, 2025, supported by the use of a priority review voucher, which shortens the standard review timeline.

EYLEA HD: Reducing Treatment Burden with Long-Acting Formulation

EYLEA HD is a longer-acting formulation of aflibercept, developed to reduce the frequency of intravitreal injections and lower the treatment burden for patients with retinal conditions. Data from the phase 3 PULSAR trial, published in August 2023, confirmed that extended dosing intervals of at least 12 weeks preserved visual acuity gains, while also enhancing adherence to treatment schedules.

QUASAR Trial Supports EYLEA HD in RVO

The sBLA submission is backed by results from the phase 3 QUASAR trial, which evaluated EYLEA HD in patients with RVO. At 36 weeks, the trial met its primary endpoint:

       • Patients receiving EYLEA HD every 8 weeks showed non-inferior visual acuity gains compared to those treated with standard-dose EYLEA (2 mg) every 4 weeks.

Safety Profile and Adverse Events

The safety profile of EYLEA HD in the QUASAR study was consistent with prior pivotal trials. The most notable ocular treatment-emergent adverse event was increased intraocular pressure, reported in:

       • 5% of EYLEA HD patients

       • 1.7% of patients receiving standard EYLEA

Additional Regulatory Developments

In parallel, Regeneron has also submitted a filing to the FDA for the use of prefilled syringes (PFSs) of EYLEA HD. Approval and commercial launch of the PFS version are anticipated by mid-2025.

On the global front, Bayer—Regeneron’s co-development partner—has filed an application with the European Medicines Agency (EMA) to expand the indication for aflibercept 8 mg in Europe.