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MEDTECH Is reproxalap on the verge of revolutionizing ocular surface inflammatory treatment?
Aldeyra Therapeutics makes strides in ocular therapy development with the promising results from its phase 3 INVIGORATE-2 clinical trial, testing the potential of the investigational new drug, reproxalap, in treating allergic conjunctivitis and dry eye disease.
Key Points:
- Aldeyra Therapeutics revealed positive topline results from the INVIGORATE-2 phase 3 clinical trial of 0.25% reproxalap ophthalmic solution.
- The clinical trial successfully met statistical significance for its primary endpoint and all secondary endpoints.
- The trial, which enrolled 131 allergic conjunctivitis patients, primarily evaluated change from baseline in patient-reported ocular itching score.
- Reproxalap-treated patients demonstrated statistically significant reduction in ocular itching score and ocular redness.
Additional Points:
- Secondary endpoints also included change in patient-reported ocular tearing score and total ocular severity score, with significant improvements noted in the reproxalap group.
- Reproxalap has been administered to more than 2,400 patients across 21 clinical trials without significant safety or tolerability concerns.
- An NDA of reproxalap for the treatment of dry eye disease is under FDA review with a PDUFA date set for November 23, 2023.
Conclusion:
- The successful results from the INVIGORATE-2 trial highlight the potential of reproxalap as a game-changing treatment for ocular surface inflammatory diseases, particularly allergic conjunctivitis and dry eye disease.
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“For patients who have had a poor response to over-the-counter ocular allergy medications, the data announced today may suggest that reproxalap could satisfy a substantial unmet need in patients who suffer from allergic conjunctivitis and dry eye disease.”
William B. Trattler, MD
Vice Chair of Research and Associate Professor of Ophthalmology at Herbert Wertheim College of Medicine
