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.