Aldeyra Therapeutics Says Additional Trial Needed For FDA Approval of Dry-Eye Disease Treatment
By Ben Glickman
Aldeyra Therapeutics will need to conduct another study of its treatment for dry-eye disease before the drug can receive approval from the U.S. Food and Drug Administration.
The Lexington, Mass.-based biotechnology company said Monday it had received a complete response letter from the FDA in response to its new drug application for reproxalap, in which the agency said the application did not demonstrate necessary efficacy.
Aldeyra will need to conduct at least one more "adequate and well-controlled study" examining the effect of reproxalap on dry-eye symptoms.
Aldeyra said it had already submitted a proposed trial to the FDA, with feedback expected in December. The company said its proposed study would cost less than $2 million and would yield results in the first half of 2024, depending on FDA feedback.
Aldeyra said it now expects its cash runway to extend into late 2025, including the costs of the additional trial.
The company is targeting a fresh new drug application submission in the first half of 2024, pending FDA feedback and results from its trial.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
November 27, 2023 16:50 ET (21:50 GMT)
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