Aldeyra Therapeutics announced that the FDA has accepted its new drug application (NDA) for 0.25% topical ocular reproxalap, an investigational new drug candidate, indicated for treating the signs and symptoms of dry eye disease (DED).
This submission follows the company’s NDA submission to the FDA in November 2022.
Tell me more about reproxalap.
Reproxalap is Aldeyra’s first-in-class, small-molecule modulator of reactive aldehyde species (RASP)— known to be elevated in ocular and systemic inflammatory disease as well as cause decreased tear production, eye redness, change in lipid tear composition, and increased ocular inflammation.
How did it perform in clinical trials?
Reproxalap performed in five adequate and well-controlled clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis.See here for additional data.
How quickly can reproxalap work?
Per study data, it shows signs of activity ranging from within minutes of administration to up to 12 weeks.
What’s next?
The FDA has designated a Prescription Drug User Act (PDUFA) date for November 23, 2023.
However, the FDA also noted that it has identified no potential filing review issues and that an advisory committee meeting is not currently planned.