Aldeyra Therapeutics (ALDX) said Thursday that it has received a complete response letter from the US Food and Drug Administration for the resubmission of its new drug application for its potential dry eye disease treatment, reproxalap.
The company said that no manufacturing or safety issues with reproxalap were identified, but the FDA's letter noted that the NDA "failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes."
The letter also stated that "at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye" should be conducted, the company said.
Aldyra said it plans to resubmit the NDA in the middle of the year, pending positive results from ongoing clinical trials and talks with the FDA.
Aldeyra shares were down 74% in recent premarket activity on Thursday.
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