Ocular Therapeutix, Inc. OCUL
Ocular Therapeutix, Inc. (Nasdaq: OCUL) is an ophthalmology drug developer. Its lead program, AXPAXLI (axitinib intravitreal implant), is in Phase 3 for neovascular (wet) age-related macular degeneration. Its next catalyst on record is AXPAXLI: Submit NDA for wet AMD (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: AXPAXLI — Submit NDA for wet AMD (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| DEXTENZA | post-surgical ocular inflammation and pain | small molecule | Approved |
| AXPAXLI | wet AMD | small molecule | Phase 3 |
Recent results and decisions
- Aug 3, 2026positive New post hoc SOL-1 analysis: up to 72% estimated reduction in treatment burden vs projected every-8-week aflibercept 2 mg over 60 weeks.
In a new post-hoc analysis of SOL-1 data applying the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline, we estimate a treatment burden reduction of up to 72% as compared to a projected on-label dosing regimen of aflibercept (2 mg) over 60 weeks.
Filing - May 5, 2026met SOL-1 met primary endpoint of superiority over aflibercept 2 mg: 74.1% vs 55.8% maintained vision at Week 36 (p=0.0006); 65.9% vs 44.2% at Week 52.
With a highly statistically significant primary endpoint (p=0.0006), SOL-1 has the potential to support the first label with a superiority claim over an anti-VEGF.
Filing - Dec 5, 2025n/a Following FDA leadership statements, company now intends to file the wet AMD NDA on SOL-1 year-1 data alone (single pivotal trial), if positive.
the Company now intends to submit a new drug application for its product candidate AXPAXLI (also known as OTX-TKI) for the treatment of wet AMD based on year 1 data from the Company’s SOL-1 Phase 3 clinical trial, without waiting for additional clinical data from SOL-1, SOL-R or other clinical trial
Filing
1 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.