As expected, US regulator rejects Aldeyra's novel dry eye drug

Citing a failure to show required efficacy, the US Food and Drug Administration has rejected a submission from Aldeyra Therapeutics (Nasdaq: ALDX) for its dry eye candidate reproxalap.

The outcome had been broadly anticipated, after the company  filed an update with the US Securities and Exchange Commission (SEC)  notifying investors that a complete response letter (CRL) could be on the cards.

The FDA said on Monday that it would need to see “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye.”