Clinical Trial ConcernsThe confounding part of the treatment was driven by a placebo group that got worse in an area of drug development where placebo patients generally get slightly better.
Drug Approval SetbackAldeyra received a CRL for the NDA of reproxalap in the treatment of dry eye disease (DED), which indicated that an additional study is required to demonstrate positive effect in the treatment of ocular symptoms.
Regulatory ChallengesThe FDA wants another trial to demonstrate control of symptoms for Reproxalap in DED, and the company has received a CRL.