The Biologics License Application for aflibercept 8 mg was supported by positive data from the PULSAR study, investigating wet AMD, and the PHOTON study, investigating DME.
Regeneron Pharmaceuticals announced that the FDA has granted priority review status to the Biologics License Application for aflibercept 8 mg (Regeneron and Bayer AG) for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy. The FDA target action date is June 27, 2023, following the use of a priority review voucher.
The Biologics License Application was supported by positive data from 2 pivotal trials, the PULSAR study of wAMD (673 patients) and the PHOTON study of DME (491 patients)that showed non-inferior vision gains compared to Eylea (aflibercept 2 mg, Regeneron) injection, with most patients achieving extended dosing regimens through 48 weeks.
If approved, aflibercept 8 mg will be second ophthalmology medicine developed by Regeneron.
According to the press release issued by Regeneron, 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 Eylea (PULSAR n = 336; PHOTON n = 167) on an 8-week dosing regimen.
The PHOTON and PULSAR studies are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or Eylea every 8 weeks.
Patients treated with aflibercept 8 mg in both trials had 3 initial monthly doses, and patients treated with Eylea received 5 initial monthly doses in the PHOTON study and 3 in the PULSAR study. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study, with those results still to be assessed. Patients in all Eylea groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.
The vast majority of patients randomized to aflibercept 8 mg in both trials maintained 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, the company reported.
Aflibercept 8 mg is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.