Eylea (Aflibercept) Becomes First FDA-Approved Treatment for Retinopathy of Prematurity

On February 8, Regeneron announced that the FDA had approved the supplemental Biologics License Application (sBLA) for aflibercept (brand name: Eylea) to treat retinopathy of prematurity (ROP). The press release stated that this is the first ROP drug approved by the FDA, and ROP is also the fifth retinal disease caused by ocular angiogenesis for which aflibercept has been approved.

This approval is mainly based on data from two global Phase III clinical trials, Firefleye (N=113) and Butterfleye (N=120), which aimed to evaluate the efficacy of aflibercept 0.4mg and laser photocoagulation in treating ROP patients. The results showed that approximately 80% of ROP infants treated with aflibercept had neither active ROP nor unfavorable structural outcomes at 52 weeks of age. In terms of safety, no new safety signals were identified.

In October 2022, the FDA granted Eylea (aflibercept) injection a 6-month pediatric exclusivity. This move extends Eylea's market exclusivity period in the U.S. by an additional 6 months until May 17, 2024. (See:)

Aflibercept, jointly developed by Bayer and Regeneron, is an intravitreal injection VEGF inhibitor and one of the best-selling products globally. According to Regeneron's financial report, the sales of Aflibercept in 2022 were $9.647 billion, increasing by 4% year-on-year. Among this, sales in the U.S. region amounted to $6.265 billion (exclusively occupied by Regeneron), while sales in markets outside the U.S. reached $3.383 billion (handled by Bayer, with Regeneron receiving $1.3 billion).

In addition, to address the fierce competition from rival products and delay the impact of generic drugs, Regeneron submitted a marketing application to the FDA in December 2022 for aflibercept 8mg in treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), utilizing a priority review voucher. It is expected to be approved for market launch in the U.S. by Q3 this year. In February this year, Bayer also submitted a marketing application for aflibercept 8mg to the EMA.

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