FDA Grants Priority Review to Aflibercept for Wet Age-Related Macular Degeneration

The FDA has granted priority review to a biologics license application (BLA) for aflibercept 8 mg (Eylea; Regeneron Pharmaceuticals, Inc.), according to a recent Regeneron press release. Aflibercept—which is under review for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy—met the primary endpoint of non-inferior vision gains at 12- and 16-week dosing regimens compared to patients on an 8-week dosing regimen in the phase 3 clinical trials PHOTON and PULSAR.

The FDA granted the BLA to aflibercept injection 8 mg based PHOTON and PULSAR data presented at the 55th Annual Scientific Session of The Retina Society in November 2022. Nearly 1.1 million people in the United States have wAMD, a retinal disease that stems from abnormal blood vessel growth.

It is more common with older age, resulting from the macula—in charge of sharp central vision and the ability to see fine details—being damaged and scarred by fluid leaking from underneath of it. The condition can lead to vision loss.

DME also causes vision loss and even blindness because fluid damages the macula, although fluid leakage from DME is caused by high blood sugar. The disease affects about 1.2 million of the 28 million American adults with diabetes.

Investigators studied aflibercept 8 mg in the double-masked, active-controlled PHOTON (wAMD) and PULSAR (DME) trials. Both the PHOTON and PULSAR trials had 3 treatment arms: patients received aflibercept 8 mg every 12 weeks, every 16 weeks, or they received aflibercept injection (2 mg) every 8 weeks.

In both trials, patients on an 8 mg regimen received 3 initial monthly doses. The 8 mg arms could have dose intervals reduced to 8 weeks if they experienced disease progression. After a 48-week trial period, aflibercept 8 mg showed a consistent safety profile to previous clinical trials for aflibercept. At least 79% of patients with wAMD and 91% of patients with DME maintained a 12-week dosing regimen through the 48 weeks, whereas 77% and 89% of the patient groups, respectively, maintained the 16-week regimen.

The most common adverse events (AEs) from aflibercept injection were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. Fewer than 0.1% of patients experienced severe AEs of endophthalmitis and retinal detachment.

Aflibercept injection 2 mg is currently indicated to treat patients with neovascular age-related macular degeneration, macular edema following retinal vein occlusion, DME, diabetic retinopathy, and retinopathy of prematurity. It is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or have a known hypersensitivity to aflibercept.

The new dose is still investigational, and its safety and efficacy are not regulated. The FDA set a target action date for June 27, 2023.

Reference

Regeneron Pharmaceuticals, Inc. AFLIBERCEPT 8 MG BLA FOR TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION AND DIABETIC MACULAR EDEMA ACCEPTED FOR FDA PRIORITY REVIEW. February 23, 2023. Accessed February 24, 2023. https://investor.regeneron.com/news-releases/news-release-details/aflibercept-8-mg-bla-treatment-wet-age-related-macular