The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy.
The BLA is supported by data from the phase 3 PULSAR (N=1009; ClinicalTrials.gov Identifier: NCT04423718) and phase 2/3 PHOTON (N=658; ClinicalTrials.gov Identifier: NCT04429503) trials, which compared the efficacy and safety of aflibercept 8mg to Eylea (aflibercept 2mg) in patients with wAME and DME, respectively. Patients were randomly assigned to receive aflibercept 8mg every 12 weeks or every 16 weeks or aflibercept 2mg every 8 weeks. The primary endpoint for both trials was the change from baseline to week 48 in best corrected visual acuity.
Results from both trials showed that treatment with aflibercept 8mg met the primary endpoint demonstrating noninferior vision gains at week 48 with both the 12- and 16-week dosing regimens after initial monthly doses vs aflibercept 2mg every 8 weeks. The majority of patients treated with aflibercept 8mg were able to maintain the 12- and 16-week dosing regimens through week 48.
In PULSAR, 71% and 67% of wAMD patients treated with aflibercept 8mg 12- and 16-week dosing regimens, respectively, had no retinal fluid in the center subfield compared with 59% of patients who received aflibercept 2mg. The median time to fluid-free subfield was 4 weeks for aflibercept 8mg vs 8 weeks for aflibercept 2mg.
In PHOTON, DME patients treated with aflibercept 8mg 12- and 16-week dosing regimens had a mean reduction in the total area of fluorescein leakage from baseline of 14mm2 and 9mm2, respectively, vs 9mm2 for aflibercept 2mg.
Aflibercept 8mg was found to have a similar safety profile to aflibercept 2mg. No cases of retinal vasculitis, occlusive retinitis or endophthalmitis were observed in either trial.
The FDA has assigned a target action date of June 27, 2023 for the application.
- Aflibercept 8mg BLA for treatment of wet age-related macular degeneration and diabetic macular edema accepted for FDA Priority Review. News release. Regeneron Pharmaceuticals, Inc. Accessed February 23, 2023. https://www.globenewswire.com/news-release/2023/02/23/2614121/0/en/Aflibercept-8-mg-BLA-for-Treatment-of-Wet-Age-Related-Macular-Degeneration-and-Diabetic-Macular-Edema-Accepted-for-FDA-Priority-Review.html.
- Aflibercept 8mg late-breaking data presented at Retina Society in diabetic macular edema and wet age-related macular degeneration. News release. Regeneron Pharmaceuticals, Inc. November 4, 2022. Accessed February 23, 2023. https://investor.regeneron.com/news-releases/news-release-details/aflibercept-8-mg-late-breaking-data-presented-retina-society.