Aldeyra Therapeutics has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.  

The CRL states that there is “a lack of substantial evidence consisting of adequate and well-controlled investigations” and that “the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease.”  

The letter also stated that the “inconsistency of study results raises serious concerns about the reliability and meaningfulness of the positive findings” and that the “totality of evidence from the completed clinical trials does not support the effectiveness of the product.” However, no safety or manufacturing concerns were identified. 

The FDA has recommended that the reasons for failure in certain trials be explored, and that populations or certain conditions in which reproxalap may be effective be identified.  

“To the thousands of American and Canadian patients who participated in our clinical trials and to the tens of millions of patients with dry eye disease worldwide, I want to assure you that we will work with urgency to support the FDA in enabling market access to what is, to our knowledge, the only drug with clinical activity within minutes of administration in patients with dry eye disease, a condition that is today treated with medications that require weeks or months of treatment to achieve even modest improvement,” stated Todd Brady, President and Chief Executive Officer of Aldeyra. 

Share prices for the company were down more than 75% following the news. In response, law firm Block & Leviton has announced it is investigating Aldeyra for potential securities law violations and encouraged investors who have lost money to get in touch.

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