FDA Accepts BLA for Aflibercept 8mg for Priority Review

The US Food and Drug Administration has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy.¹

Announced in a news release by Regeneron Pharmaceuticals Inc., the FDA target action date is June 27, 2023, following a priority review voucher. The BLA was supported by positive data from two pivotal trials: PULSAR for wet AMD and PHOTON for DME.

These data were previously presented at the 55th Annual Scientific Sessions of the Retina Society in November 2022. If approved, aflibercept 8 mg will be the second ophthalmology treatment developed by Regeneron.

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

Results suggest the majority of patients randomized to aflibercept 8 mg in both trials maintained 12- and 16-week dosing regimens to which they were respectively initiated through 48 weeks (wet AMD: 79% and 77%; DME: 91% and 89%). In addition, the safety profile for aflibercept 8 mg was similar to EYLEA® in both trials, as well as consistent with the known safety profile reported in previous clinical trials.

Ocular adverse events occurred in 31% (n = 491) of patients treated with aflibercept 8 mg versus 28% (n = 167) treated with EYLEA® in the PHOTON trial, and 38% (n = 673) versus 39% (n = 336) in the PULSAR trial. The release noted no cases of retinal vasculitis, occlusive retinitis, or endophthalmitis were reported in either trial.

Aflibercept 8mg is being jointly developed by Regeneron and Bayer AG. The lead sponsors of the trials were Regeneron for PHOTON and Bayer for PULSAR. The release indicates that aflibercept 8 mg is investigational and safety and efficacy have not been evaluated by any regulatory authority.

References

1. Aflibercept 8 mg bla for treatment of wet age-related macular degeneration and Diabetic macular edema accepted for FDA Priority Review. Regeneron Pharmaceuticals Inc. https://investor.regeneron.com/news-releases/news-release-details/aflibercept-8-mg-bla-treatment-wet-age-related-macular. Published February 23, 2023.