Regeneron's Aflibercept 8mg Receives FDA Priority Review for Every-Four-Month Dosing in Retinal Diseases

On February 23, Regeneron announced that the marketing application for aflibercept 8mg has been granted Priority Review by the FDA for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy. The PDUFA date is June 27, 2023. If approved, aflibercept 8mg will become the second ophthalmology drug developed by Regeneron.

This application is based on the positive data from the Phase III PULSAR study of aflibercept 8mg for the treatment of wAMD and the Phase II/III PHOTON study for the treatment of DME.

At week 48, both studies met the primary endpoint of non-inferiority, showing that aflibercept 8mg dosed every 12 or 16 weeks was non-inferior to aflibercept 2mg dosed every 8 weeks in improving Best Corrected Visual Acuity (BCVA) scores. The vast majority of patients were able to maintain the 12- or 16-week injection interval. The success of these two pivotal studies means that the aflibercept 8mg formulation can extend the treatment interval from every 2 months to every 4 months.

In these two studies, the safety of 8mg Aflibercept was similar to that of 2mg Aflibercept, and no patients experienced adverse reactions such as retinal vasculitis, occlusive retinitis, or endophthalmitis.

Aflibercept was co-developed by Bayer and Regeneron. Regeneron retains exclusive rights to aflibercept in the United States, while Bayer has obtained exclusive marketing rights outside the United States.

According to Regeneron's financial report, the sales of Eylea (Aflibercept 2mg) reached $9.647 billion in 2022, increasing by 4% year-on-year. Among this, the sales in the United States were $6.265 billion (exclusively occupied by Regeneron), and the sales in markets outside the United States were $3.383 billion (handled by Bayer, of which Regeneron received $1.3 billion).

This month, Bayer also announced that it has submitted a marketing application to the European Medicines Agency (EMA) for the 8mg formulation of aflibercept for the treatment of wAMD and DME.

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