Aldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study

Aldeyra Therapeutics Inc ALDX reported topline data from Phase 3 TRANQUILITY Trial of reproxalap ophthalmic solution for dry eye disease.

• The trial failed to meet the primary endpoint of ocular redness, but it did achieve statistical significance for the dry eye disease sign of the Schirmer test, a secondary endpoint. 
• Statistical significance was also achieved for the post-hoc assessment of Schirmer test responders of over 10 mm. 
• Related: Aldeyra's Dry Eye Disease Trial Meets Primary Endpoint But Misses On Secondary Endpoint.
• The primary endpoint of the upcoming Phase 3 TRANQUILITY-2 trial has been modified such that the endpoint will have been met if either the Schirmer test or ocular redness demonstrates statistical significance. 
• In addition, target enrollment in TRANQUILITY-2 has been increased from 300 to up to 400 patients. The company expects topline results in mid-2022.
• The company intends to file the marketing application for dry eye disease indication in mid-2022.
• Application for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA. 
• No safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.
• Price Action: ALDX shares are down 38.9% at $4.36 during the premarket session on the last check Tuesday.