Aldeyra Therapeutics, Inc. ALDX
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) is an ophthalmology drug developer. Its lead program, reproxalap, is in Phase 3 for dry eye disease and allergic conjunctivitis. Its next catalyst on record is reproxalap: FDRR meeting with FDA Office of New Drugs (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: reproxalap — FDRR meeting with FDA Office of New Drugs (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| reproxalap | dry eye disease and allergic conjunctivitis | small molecule | Phase 3 |
| ADX-2191 | primary vitreoretinal lymphoma | small molecule | Phase 3 |
| ADX-248 | systemic and retinal immune-mediated diseases | small molecule | Phase 2 |
| ADX-246 | systemic and retinal immune-mediated diseases | small molecule | Pre-clinical |
Recent results and decisions
- Sep 29, 2026submitted Aldeyra intends to submit a Formal Dispute Resolution Request (FDRR) to FDA's Office of New Drugs for reproxalap for the treatment of dry eye disease, with submission and meeting expected in Q4 2026.
Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026.
Filing - May 1, 2026met Phase 3 INVIGORATE allergen chamber trials met the primary endpoint of ocular itching with all P values < 0.0001.
All P values < 0.0001
Filing - Mar 17, 2026CRL FDA issued a CRL for reproxalap in dry eye disease citing lack of substantial evidence of efficacy; no safety or manufacturing concerns and no new trials requested.
the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 ophthalmology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.