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# 2 Eylea HD Submissions Get Review Extensions
- URL: https://www.fdaweb.com/2-eylea-hd-submissions-get-review-extensions/
- Published: 2025-08-20T12:00:00.000Z
- Updated: 2026-09-14T15:19:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159727

FDA has extended until the fourth quarter the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept) injection 8 mg regulatory submissions because information submitted to address a recent inspection was deemed a major amendment. One submission was a chemistry, manufacturing and controls prior-approval supplement for the Eylea HD prefilled syringe, and the other was a supplemental BLA seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every four-week (monthly) dosing across approved indications, according to the company.

Regeneron says it expected the review extensions and discussed their likelihood during the company’s [second quarter 2025 earnings announcement](https://www.globenewswire.com/Tracker?data=8jGBI4mA4VEyvduJlM313Ts14QuedH2mOalsetYrbLX-iacCG4oUqnrZLJ0LKL1WhKZmc5NNfAATN9uOA2vkifhgRPGfXB6-LzTDppzuhmCBnEGhhalukVqWJoFHYF4PXGQNT5FZ0FQBGBh3J7BbsX6VWdbrm2LsR62cs8XsAWJWAy3azLM9zkHrzsTsBMVZznq7GtwJLsTFwQQ18JGSqUcZYm-rVs0oM4YTJ4zeId5DM4yxPk1dZnuBJlXWWzv81ljg9DKb7xyRwopfa3vP5A==&ref=fdaweb.com), which noted observations during an FDA general site inspection at the filer for these regulatory applications, Catalent Indiana. “Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA,” a company statement says. “It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved.”

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.