> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Complete Response on Higher Dose Eylea
- URL: https://www.fdaweb.com/complete-response-on-higher-dose-eylea/
- Published: 2023-06-27T12:00:00.000Z
- Updated: 2026-09-14T18:41:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154778

FDA has issued a complete response letter (CRL) on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye drug for treating patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. The submission is being held up “solely due to an ongoing review of inspection findings at a third-party filler,” the company says. “The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested,” it says. Currently, Eylea is approved in a 2 mg dosage formulation.