Regeneron Raises Possibility Of Quick CRL Resolution For High-Dose Eylea

Regeneron Pharmaceuticals, Inc. gave investors some unexpected potential good news during its second quarter sales and earnings call on 3 August, saying that its US filing of high-dose Eylea may obtain approval during the current quarter, perhaps even before the end of August, following a US Food and Drug Administration complete response letter on 27 June.

Eylea (aflibercept), an anti-VEGF agent, is approved for dosing every eight weeks at 2mg and has become the standard of care in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), with indications also for diabetic retinopathy and macular edema following retinal vein occlusion. But since 2022, it has been losing market share in wet AMD and DME to Roche Holding AG’s bispecfic antibody therapy Vabysmo (faricimab), which works by blocking both VEGF and Ang-2 and can be dosed every fourth months after a run-in period