> ## 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.

# Regeneron Responding to Eylea ‘Complete Response’
- URL: https://www.fdaweb.com/regeneron-responding-to-eylea-complete-response/
- Published: 2023-08-03T12:00:00.000Z
- Updated: 2026-09-14T18:48:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155024

Regeneron says it will respond to a recent FDA complete response letter (CRL) on the company’s BLA for a higher dose of Eylea (aflibercept) 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The agency has told Regeneron and contract vial filler Catalent that certain manufacturing data and other information are required to allow approval of the submission. Regeneron says it “expects these data and information to be submitted to the FDA by mid-August 2023\. The FDA has stated that it intends to prioritize the review of this submission, and therefore the company anticipates the FDA will take action on the aflibercept 8 mg BLA during the third quarter of 2023.”

Regeneron says the CRL was issued “solely due to unresolved observations resulting from an FDA inspection at a third-party contract manufacturing organization, Catalent… The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety profile, trial design, labeling, or drug substance manufacturing, and no additional clinical data or trials have been requested.”

Last month, FDA released Catalent’s four-page[ Form FDA-483](https://www.fda.gov/media/170260/download?ref=fdaweb.com) that was issued after the agency inspected the firm’s Bloomington, IN manufacturing facility 5/4-12\. According to the inspection form, Catalent was cited over written production and process control procedures not being followed or established. Additionally, the agency said the facility’s equipment revalidation is inadequate, and equipment and facilities are not adequately maintained or cleaned.