Regeneron high-dose Eylea gains FDA approval (NASDAQ:REGN)

The US FDA has approved Regeneron Pharmaceuticals’ (NASDAQ:REGN) high-dose (“HD”) version of its blockbuster therapy Eylea (aflibercept).

The new formulation allows patients to receive treatment less frequently. HD Eylea is dosed every 4 weeks for the first 3 months, then every 8 to 16 weeks in wet age-related macular degeneration and diabetic macular edema and every 8 to 12 weeks for diabetic retinopathy.

While the standard Eylea dose is 2 mg, HD Eylea is 8 mg.

Approval was based on the results of the ULSAR and PHOTON studies which compared HD to standard Eylea. HD Eylea met the primary endpoint, demonstrating non-inferiority and clinically equivalent vision gains to standard Eylea at 48 weeks.

Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) has marketing rights for HD Eylea outside the US. The drug is under review in Japan and by the European Medicines Agency.

The FDA issued a Complete Response Letter for HD Eylea in June due to issues at a third-party contract manufacturer.

HD Eylea is seen as competing with Roche’s (OTCQX:RHHBY) Vabysmo (faricimab), with the dosing of the latter as infrequently as every four months.

Vabyso brought in CHF 957M (~$1.1B) in the first half of 2023. Eylea had revenue of ~$2.9B over the same period, though that was a 4% decline from the year-ago period.