According to Regeneron, the BLA is supported by two pivotal trials demonstrating non-inferior vision gains to aflibercept injection, with a majority of patients maintaining extended dosing regimens through 48 weeks.
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.