Regeneron Pharmaceuticals (REGN) said Thursday that its supplemental biologics license application for Eylea HD 8 mg injection has been accepted for priority review by the US Food and Drug Administration, with a decision expected by Aug. 19.
The company said it is seeking approval for Eylea, or aflibercept, to treat macular edema following retinal vein occlusion and to expand Eylea HD's dosing schedule to include every 4-week dosing across approved indications.
The submission is backed by data from a phase 3 trial, which showed that patients who received Eylea HD every 8 weeks achieved similar vision outcomes compared with those receiving the drug every 4 weeks, the company said.
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