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Regeneron’s Eylea Receives FDA Clearance for 8 MG Treatment


Medication is the first approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses.

Eye: treatment of macular degeneration by RNA interference. Generative AI. Image Credit: Adobe Stock Images/Bronks

Image Credit: Adobe Stock Images/Bronks

Regeneron Pharmaceuticals has confirmed approval of Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) by the FDA. According to the company, the recommended dose starts at eight mg every four weeks for the first three months across all indications, followed by eight mg every two to four months in wAMD and DME and every two to three months for DR.

“More than 10 years ago, we fundamentally changed the way that certain serious retinal diseases were treated with the introduction of Eylea. With the approval of Eylea HD, we have elevated the high standard that Eylea set,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, and a principal inventor of Eylea, according to a company press release. “Our continued commitment to retinal diseases resulted in an important scientific innovation – evolving the proven efficacy and safety of Eylea into a new treatment, Eylea HD, that provides lasting vision control with even fewer injections to further benefit those living with wet age-related macular degeneration or diabetic retinal diseases."

Reference: EYLEA HD (AFLIBERCEPT) INJECTION 8 MG APPROVED BY FDA FOR TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION (WAMD), DIABETIC MACULAR EDEMA (DME) AND DIABETIC RETINOPATHY (DR). Regeneron. August 18, 2023. Accessed August 22, 2023. https://investor.regeneron.com/news-releases/news-release-details/eylea-hd-aflibercept-injection-8-mg-approved-fda-treatment-wet

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