Oculis Holding AG OCS
Oculis Holding AG (Nasdaq: OCS) is an ophthalmology drug developer. Its lead program, OCS-01 (OPTIREACH dexamethasone eye drop), is in Phase 3 for Diabetic macular edema (DME). Its next catalyst on record is Licaminlimab (OCS-02): PREDICT-1 registrational Phase 2/3 topline results (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Licaminlimab (OCS-02) — PREDICT-1 registrational Phase 2/3 topline results (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| OCS-01 | Diabetic macular edema (two ongoing Phase 3 trials as of 20-F) | small molecule | Phase 3 |
| Licaminlimab (OCS-02) | Dry eye disease, genotype-based (PREDICT-1 registrational Phase 2/3) | antibody | Phase 2 |
| Privosegtor (OCS-05) | Optic neuritis and non-arteritic anterior ischemic optic neuropathy (PIONEER registrational program) | small molecule | Phase 2 |
Recent results and decisions
- May 29, 2026missed DIAMOND-1 missed primary endpoint: week-52 BCVA change 1.2 letters OCS-01 vs 5.1 vehicle (p NS); retinal thickness reduced
The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52, was not met in both trials.
Filing - May 11, 2026positive FDA agreed a Special Protocol Assessment for the PIONEER-1 registrational trial design and analysis in optic neuritis
In May 2026, we received written agreement from the FDA under a Special Protocol Assessment (SPA) regarding PIONEER-1 to confirm that the design and planned analysis of the PIONEER-1 study are adequate to address the objectives necessary to support a future NDA submission
Filing - Mar 3, 2026positive FDA granted Breakthrough Therapy designation to Privosegtor for optic neuritis, supported by Phase 2 ACUITY
Breakthrough Therapy designation recently granted by the FDA for treatment of optic neuritis (ON)
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.