FDA points CRL for Aldeyra’s reproxalap drug software
The U.S. Meals and Drug Administration (FDA) has despatched a whole response letter (CRL) to Aldeyra Therapeutics for its new drug software (NDA) of reproxalap for the remedy of dry eye.
This CRL acknowledged that the appliance lacks substantial proof of efficacy from sufficient and well-controlled medical research underneath the proposed circumstances of use.
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The FDA famous inconsistencies within the research outcomes, elevating considerations concerning the significance and reliability of optimistic outcomes.
The letter additionally acknowledged that the totality of proof from accomplished research doesn’t assist the efficacy of reproxalap for dry eye. Nevertheless, the assessment didn’t reveal any security or manufacturing points associated to the product.
Throughout the assessment course of, the FDA supplied label designs in December 2025 and March 2026. Aldeyra Therapeutics famous that label negotiations had not but been accomplished.
The company beneficial additional analysis into the explanations for the failure of sure trials and recommended figuring out populations or circumstances wherein reproxalap could also be efficient.
The FDA didn’t suggest conducting further research or requesting additional confirmatory proof presently.
Consequently, the corporate doesn’t anticipate to conduct any new research and plans to request a Sort A gathering with the company to make clear the actions required for approval.
The goal date for this assembly is inside 30 days of receipt of the assembly request, per the needs of the Prescription Drug Reimbursement Act.
Aldeyra Therapeutics president and CEO Todd Brady stated, “To the 1000’s of U.S. and Canadian sufferers who’ve participated in our medical trials and to the tens of tens of millions of dry eye sufferers worldwide, I need to guarantee you that we are going to work expeditiously to assist the FDA in enabling market entry to what, to our information, is the one drug with medical exercise inside minutes of administration in sufferers with dry eye, a situation at this time handled with drugs that require weeks or months of remedy to realize even modest enchancment.”
As of December 31, 2025, Aldeyra Therapeutics reported money, money equivalents and marketable securities totaling $70 million, which is predicted to assist operations via 2028.
