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# Eylea OK’d After Fixing Inspection Findings
- URL: https://www.fdaweb.com/eylea-okd-after-fixing-inspection-findings/
- Published: 2023-08-21T12:00:00.000Z
- Updated: 2026-09-14T18:51:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155143

After resolving inspection concerns at its contract manufacturer (Catalent) that were raised in a 6/27 complete response letter (CRL), Regeneron Pharmaceuticals was granted FDA approval 8/18 for Eylea HD (aflibercept) injection 8 mg, a higher dose of the popular 2 mg treatment for patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended dose for Eylea HD is 8 mg once per month for three months and then followed by 8 mg every two to four months in wAMD and DME and every two to three months for DR, according to the company.

Earlier this month, Regeneron said it was responding to the CRL by mid-month to provide certain manufacturing data and other information that FDA needed to allow approval of the submission. After it received the CRL in June, the company said FDA had not identified any issues with the drug’s clinical efficacy or safety profile, trial design, labeling, or drug substance manufacturing, and no additional clinical data or trials had 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.