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FDA Issues Complete Response Letter for Astellas' IZERVAY and Accepts Aldeyra's NDA for Reproxalap

• The FDA issued a Complete Response Letter for Astellas' IZERVAY (avacincaptad pegol) due to a statistical matter regarding proposed labeling language, unrelated to safety or efficacy. • Aldeyra Therapeutics' resubmitted New Drug Application (NDA) for reproxalap, a topical ocular treatment for dry eye disease, has been accepted by the FDA. • Aldeyra Therapeutics is expanding its option agreement with AbbVie, providing additional funding to support the commercialization of reproxalap for dry eye.

The FDA has recently taken action on two ophthalmic drugs. Astellas Pharma Inc. received a Complete Response Letter (CRL) from the FDA for its avacincaptad pegol intravitreal solution, marketed as IZERVAY, while Aldeyra Therapeutics announced the FDA's acceptance of its New Drug Application (NDA) for reproxalap.

IZERVAY's Complete Response Letter

On November 15, Astellas Pharma Inc. received a CRL from the FDA regarding its supplemental New Drug Application for IZERVAY. The expected Prescription Drug User Fee Act (PDUFA) date for IZERVAY was November 19. According to Astellas, the FDA's concerns outlined in the CRL do not pertain to the safety, efficacy, or risk profile of IZERVAY. Instead, the rejection is based on a statistical issue related to the proposed labeling language for the product.

Reproxalap's NDA Acceptance and AbbVie Agreement

Aldeyra Therapeutics announced that the FDA has accepted its resubmitted NDA for reproxalap, a first-in-class investigational topical ocular drug intended to treat the signs and symptoms of dry eye disease. In conjunction with this announcement, Aldeyra is expanding its option agreement with AbbVie, providing the company with more capital to facilitate the drug's market launch.
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Reference News

[1]
What happened in optometry this week: November 18 - November 22
optometrytimes.com · Nov 23, 2024

US FDA issues Complete Response Letter for avacincaptad pegol (IZERVAY) due to a statistical matter; Aldeyra Therapeutic...

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