HomeMarket NewsAldeyra Therapeutics' Dry Eye Drug Faces FDA Roadblock

Aldeyra Therapeutics’ Dry Eye Drug Faces FDA Roadblock

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Iryna Drozd

The dreams of Aldeyra Therapeutics’ (NASDAQ:ALDX) to treat dry eye disease have been dashed by the FDA, with the regulatory agency requesting additional evidence of the effectiveness of the drug reproxalap.

The FDA has issued a Complete Response Letter, indicating that the company must conduct at least one more well-controlled study to demonstrate a positive effect on dry eye treatment.

The agency had been expected to make a decision on whether to approve the drug by Nov. 23, but Aldeyra now faces an uphill battle to satisfy the FDA’s demands.

Aldeyra has submitted a Special Protocol Assessment for the proposed trial and is awaiting feedback from the FDA. The company hopes to resubmit its New Drug Application in 2024, with high hopes for a positive outcome.

Despite this setback, Aldeyra remains optimistic about its financial position, with a healthy cash reserve and extended cash runway guidance into late 2025.

In addition to dry eye treatment, Aldeyra is also developing reproxalap for allergic conjunctivitis, with plans to discuss a potential NDA submission with the FDA in the first half of 2024.

While the company faces challenges with the FDA, the future remains uncertain for Aldeyra and its ambitions.

(Updates headline.)

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