Regeneron Says Phase 3 Trial of Higher Dose Eye Drug Eylea HD Meets Primary Target

MT Newswires Live12-17

Regeneron Pharmaceuticals (REGN) said Tuesday its phase 3 trial evaluating Eylea HD injection 8 mg in patients with macular edema following retinal vein occlusion met its primary endpoint.

The study demonstrated that patients treated with Eylea HD every 8 weeks, following three or five initial monthly doses, achieved non-inferior vision gains at 36 weeks compared with the patients receiving the standard monthly dosing of Eylea 2 mg, according to Regeneron.

The results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions, the company said, adding Eylea HD's safety profile is comparable to Eylea.

Regeneron said it plans to submit a supplementary biologics license application to the US Food and Drug Administration in Q1 2025.

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