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Aflibercept 8mg BLA Granted FDA Priority Review for Wet AMD and DME Treatment

Aflibercept 8mg BLA Granted FDA Priority Review for Wet AMD and DME Treatment

February 27, 2023

Regeneron Pharmaceuticals announced that its Biologics License Application (BLA) for aflibercept 8 mg, has been accepted by the FDA for priority review. The drug is intended for the treatment of patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy. A priority review voucher has been used, and the FDA has set a target action date of June 27, 2023.

The BLA is backed by positive data from two pivotal trials, PULSAR in wet AMD and PHOTON in DME. The data was 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) showed non-inferiority in vision gains for both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks. This was compared to patients treated with an Eylea (aflibercept) injection (PULSAR n=336; PHOTON n=167) 8-week dosing regimen, meeting the primary endpoint.

The majority of patients randomized to aflibercept 8 mg in both trials were able to maintain their respective 12- and 16-week dosing regimens 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 Eylea's known safety profile from previous clinical trials. In terms of ocular adverse events, there were 31% (n=491) versus 28% (n=167) in PHOTON and 38% (n=673) versus 39% (n=336) in PULSAR for aflibercept 8 mg and Eylea, respectively. Both trials had no cases of retinal vasculitis, occlusive retinitis or endophthalmitis.

Regeneron and Bayer AG are jointly developing aflibercept 8 mg. Regeneron holds exclusive rights to Eylea and aflibercept 8 mg in the US. Outside the US, Bayer holds exclusive marketing rights, and the profits from sales of Eylea and future sales of aflibercept 8 mg following regulatory approvals are shared equally by the two companies.

About the Aflibercept 8 mg Trial Program

The PHOTON trial in DME and PULSAR trial in wet AMD are double-masked, active-controlled pivotal trials being conducted in multiple centers worldwide. In both trials, patients were randomly assigned to one of three treatment groups: receiving aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or Eylea every 8 weeks.

In both trials, patients treated with aflibercept 8 mg had 3 initial monthly doses, whereas those treated with Eylea received 5 initial monthly doses in PHOTON and 3 in PULSAR. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened to an every 8-week interval if the protocol-defined criteria for disease progression were observed. However, intervals could not be extended until the second year of the study, and the results are still pending. Patients in all Eylea groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.