Latest news with #Reproxalap
Business Insider
06-05-2025
- Health
- Business Insider
Aldeyra's reproxalap achieves primary endpoint in Phase 3 dry eye disease trial
Aldeyra (ALDX) announced the achievement of the primary endpoint in a Phase 3 dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. For the prespecified primary endpoint of ocular discomfort, a symptom of dry eye disease, reproxalap was statistically significantly superior to vehicle on ocular discomfort symptom score from 80 to 100 minutes after chamber entry. Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the FDA feedback received in April in response to the prior NDA. The letter identified concerns with a previously completed dry eye chamber trial that may have affected the interpretation of the results. Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid-2025, and the review period is expected to be six months. There were no safety signals or treatment-related discontinuations observed in either of the recently completed clinical trials, and reproxalap was observed to be well tolerated. Reproxalap has now been studied in over 2,900 patients.
Business Wire
05-05-2025
- Business
- Business Wire
Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Topline Results from Phase 3 Dry Eye Disease Clinical Trials of Reproxalap
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Tuesday, May 6, 2025, at 8:00 a.m. ET to announce topline results from Phase 3 dry eye disease clinical trials of reproxalap. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 127477. A live audio webcast of the conference call will also be accessible from the 'Investors & Media' section of Aldeyra's website at After the live webcast, the event will remain archived on Aldeyra's website for 90 days. About Reproxalap Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology. Reproxalap is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials. About Aldeyra Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-629, ADX‑248, ADX-743, ADX-631, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa.
