FDA accepts aflibercept 8 mg BLA for treatment of wet AMD and DME for priority review

Regeneron noted the BLA is supported by positive data from two pivotal trials that were previously presented at the 55th Annual Scientific Session of The Retina Society in November 2022. (Image courtesy stock.adobe.com)

Regeneron Pharmaceuticals Inc. today announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg (EYLEA) for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy.

According to the news release, the FDA target action date is June 27, 2023 following the use of a priority review voucher.

Regeneron noted the BLA is supported by positive data from two pivotal trials – PULSAR in wAMD and PHOTON in DME – that were previously presented at the 55th Annual Scientific Session of The Retina Society in November 2022.

In both trials, patients treated with aflibercept 8 mg (PULSAR n = 673; PHOTON n = 491) met the primary endpoint of non-inferiority in vision gains for both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to patients treated with an aflibercept injection (PULSAR n = 336; PHOTON n = 167) 8-week dosing regimen.

Moreover, the company noted the vast majority of patients randomly assigned to aflibercept 8 mg in both trials were able to maintain the 12- and 16-week dosing regimens to which they were respectively initiated through 48 weeks (wAMD: 79% and 77%; DME: 91% and 89%). The safety profile for aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials.

Comparing aflibercept 8 mg to EYLEA, ocular adverse events occurred in 31% (n=491) versus 28% (n=167) in PHOTON and 38% (n=673) versus 39% (n=336) in PULSAR, and there were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in either trial.

According to the news release, aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the United States, Regeneron maintains exclusive rights to EYLEA and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the United States, where the companies share equally the profits from sales of EYLEA and future sales of aflibercept 8 mg following any regulatory approvals.

Aflibercept 8 mg is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

The lead sponsors of the trials were Regeneron for PHOTON and Bayer for PULSAR.