Regeneron Pharmaceuticals (Nasdaq:REGN) has received an indication for Eylea (aflibercept) injection for preterm infants with retinopathy of prematurity (ROP).
The approval is the first pharmacologic treatment for the condition, which affects roughly 50% to 70% of infants with a weight less than 1250 grams (2.76 pounds) at birth. The condition is more common in infants born before 31 weeks of pregnancy.
The condition is a common cause of childhood blindness.
A growing number of indications
FDA first approved Eylea for wet age-related macular degeneration in 2011. Indications followed for diabetic macular edema, macular edema following retinal vein occlusion and diabetic retinopathy in patients with diabetic macular edema.
The approval is based on data from two global Phase 3 trials, FIREFLEYE and BUTTERFLEYE. The studies compared EYLEA to laser photocoagulation in infants with ROP. The data showed that approximately 80% of EYLEA-treated infants had an absence of active ROP and unfavorable structural outcomes at 52 weeks, better than expected without treatment. In addition, no new safety signals were observed in either trial, which tested a 0.4 mg dose of aflibercept.
Regeneron noted in October that FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for aflibercept injection to treat ROP in preterm infants.
EYLEA is jointly developed by Regeneron and Bayer, with Regeneron maintaining rights to distribute the drug in the U.S. and Bayer holding rights elsewhere.
In the third quarter of 2022, Eylea’s sales growth of 11% exceeded the VEGF inhibitor class growth of 4%.
The drug generated $9.2 billion for Regeneron and Bayer in 2021.
In 2022, Roche won FDA approval for Vabysmo, a longer-acting VEGF inhibitor. Analysts at Evaluate project the drug will have $1.1 billion in sales by 2026.
Regeneron hopes to fend off the competition with a higher-dose version of Eylea. Last year, the company shared the results of two late-stage trials demonstrating that an 8 mg dose of aflibercept offered sustained treatment intervals in patients with neovascular eye disease.
The company anticipates winning FDA approval for the higher-dose version of the drug later this year.
Viatris (Nasdaq:VTRS) and Momenta Pharmaceuticals, a subsidiary of Johnson & Johnson (NYSE:JNJ), are collaborating on developing MYL-1701P, a biosimilar of aflibercept.
Filed Under: Ophthalmology
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