Aldeyra Therapeutics Reports the US FDA Acceptance of NDA for Reproxalap to Treat Dry Eye Disease
Shots:
- The US FDA has accepted the NDA of reproxalap, a small-molecule modulator of RASP for dry eye disease. The expected PDUFA date is Nov 23, 2023
- The NDA was based on the safety & efficacy results from 5 trials, incl. the P-III trial (TRANQUILITY-2) in 361 patients with dry eye disease. The (TRANQUILITY-2) study results showed that reproxalap was statistically superior to the vehicle for each of the 2 prespecified 1EPs, Schirmer test & ≥100mm Schirmer test responder proportions after a single day of dosing
- In the P-II study, patient-reported ocular discomfort and itching were found to be statistically lower in patients treated with reproxalap over lifitegrast & no clinically significant safety concerns were reported
Ref: Businesswire | Image: Aldeyra Therapeutics
Related News:- Aldeyra Therapeutics to Advance ADX-1612 to Clinical Testing and Provides Update on ADX-629 for COVID-19
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