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 (also allergic conjunctivitis). Its next catalyst on record is ADX-2191: ADX-2191 Phase 3 PVRL trial initiation now expected in 2027 (previously H1 2026). (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: ADX-2191 — ADX-2191 Phase 3 PVRL trial initiation now expected in 2027 (previously H1 2026). (2027). 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 (NDA previously submitted, resubmission pending) | small molecule | Phase 3 |
| reproxalap | allergic conjunctivitis | small molecule | Phase 3 |
| ADX-2191 | primary vitreoretinal lymphoma; retinitis pigmentosa | small molecule | Phase 3 |
| ADX-248 | systemic and retinal immune-mediated diseases | small molecule | Pre-clinical |
| ADX-246 | systemic and retinal immune-mediated diseases | small molecule | Pre-clinical |
Recent results and decisions
- Sep 29, 2026n/a After Type A and Type D meetings, Aldeyra intends to file a Formal Dispute Resolution Request with FDA's Office of New Drugs to appeal the March 2026 CRL.
Aldeyra intends to submit a Formal Dispute Resolution Request (FDRR) to the Office of New Drugs (OND).
Filing - 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
2 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.