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FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns - Aldeyra Therapeutics (NASDAQ:ALDX)

  • The FDA issued a Complete Response Letter for Aldeyra's reproxalap NDA resubmission on April 3, 2025.
  • Aldeyra resubmitted their application in October 2024, after an initial rejection in November 2023.
  • The FDA's concerns stemmed from data interpretation, potentially influenced by methodological issues within the trial.
  • The FDA stated, "the NDA failed to demonstrate efficacy in treating ocular symptoms associated with dry eyes."
  • Aldeyra plans a Type A meeting with the FDA and expects to resubmit the NDA by mid-2025, pending trial results.
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FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues

Citing "objectionable conditions," the agency said there were problems with the way Raptim Research tested medicines in India.

·Boston, United States
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Bluefield Daily TelegraphBluefield Daily Telegraph
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BREAKING: Block & Leviton Investigating Aldeyra Therapeutics (ALDX) For Securities Fraud ...

BOSTON, April 03, 2025 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) for potential securities law violations. Investors who have lost money in their Aldeyra Therapeutics, Inc. investment should contact the firm to learn more…

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BenzingaBenzinga
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FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns - Aldeyra Therapeutics (NASDAQ:ALDX)

The FDA rejected Aldeyra's resubmission for reproxalap, citing efficacy concerns. The company plans another trial and aims to resubmit the NDA by mid-2025.

·New York, United States
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Pharmacy TimesPharmacy Times

FDA Issues Complete Response Letter to Manufacturer of Reproxalap, Treatment for Dry Eye Disease, Allergic Conjunctivitis

No manufacturing or safety issues were identified, but the FDA stated the new drug application did not demonstrate efficacy in adequate and well-controlled studies.

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Endpoints NewsEndpoints News

Aldeyra gets another CRL for its dry eye disease drug that AbbVie has the option to co-develop

The FDA once again rejected Aldeyra's potential dry eye disease treatment, known as reproxalap, as the agency requested more trial data after the resubmitted drug approval request "failed to demonstrate efficacy in adequate and well ...

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ajmc.comajmc.com

Reproxalap Receives Complete Response Letter From FDA for Use in Dry Eye Disease

The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish efficacy, according to the FDA.

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HOSPITALS MAGAZINE broke the news in on Thursday, April 3, 2025.
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