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As such, the company announced plans to submit an application that will “include a new (PFS) manufacturing filler in the EYLEA HD BLA” by January 2026. Nice! And what about that second portion of the application? Regeneron’s request for every-4-week dosing and that additional indication (macular edema following RVO) is still under review.. FDA delays Regeneron application review after inspection at Novo Nordisk Indiana site The review extension follows FDA observations at a former Catalent facility now owned by Novo Nordisk, which handles final preparation and packaging of Eylea HD.

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Regeneron also noted its plans to submit an application to include an alternate PFS manufacturing filler for the EYLEA HD BLA to the FDA by January 2026. References: EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications.. The Office of Pharmaceutical Quality (OPQ), CDER, has completed assessment of BLA 761355 for Eylea HD manufactured by Regeneron Pharmaceuticals, Inc. The data submitted in this application are not sufficient to support a conclusion that the manufacture of Eylea HD is well-controlled and will lead to a product that is pure and potent.