Lacking Evidence, FDA Rejects Aldeyra Dry Eye Disease Drug

Lacking Evidence, FDA Rejects Aldeyra Dry Eye Disease Drug

Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a "lack of substantial evidence" that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab's commercialization.

FDA issues CRL to Aldeyra’s reproxalap drug application

The FDA has issued a CRL to Aldeyra Therapeutics for its new drug application (NDA) of reproxalap to treat dry eye disease.The post FDA issues CRL to Aldeyra’s reproxalap drug application appeared first on Hospital Management.

Aldeyra dry eye drug gets third rejection from FDA, triggering stock slide

Aldeyra Therapeutics was hoping the third time would be the charm for its dry eye drug this St. Patrick's Day. No such luck. The FDA on Tuesday once again rejected the ...

FDA Issues Third Complete Response Letter to Aldeyra Therapeutics for Dry Eye Drug Reproxalap

In another setback for Aldeyra Therapeutics, the FDA issued a third Complete Response Letter (CRL) regarding its new drug application (NDA) for investigational dry eye treatment reproxalap. In the letter, the FDA stated that the application failed to provide sufficient evidence of effectiveness. Specifically, the agency cited “a lack of substantial evidence consisting of adequate and well-controlled investigations” demonstrating that reproxalap …