Oculis Holding AG Previewing the Phase 3 Stage 2 DIAMOND Results in Diabetic Macular Edema (DME)

Research evidence excerpt

Oculis Holding AG Previewing the Phase 3 Stage 2 DIAMOND Results in Diabetic Macular Edema (DME)

Executive Summary

Oculis Holding AG (OCS) – OW, Dec 2026 PT $42

We can expect to see the topline results in a joint disclosure from Oculis’s two global pivotal phase 3 clinical trials (stage 2

of DIAMOND-1 and -2) evaluating OCS-01 for the treatment of diabetic macular edema (DME) in June 2026, that if

positive, should enable an NDA submission to the FDA in 4Q26.

1. OCS-01 is a topical, high-concentration dexamethasone eye drop that leverages Oculis’s OPTIREACH solubilizing

formulation technology to enable drug delivery to the back of the eye. Historically, using topical administration to

achieve therapeutic drug concentrations in the posterior segment of the eye has generally been challenging, due to

the anatomic barriers to drug penetration and the distance from the surface of the eye.

2. If successful, the profile of OCS-01 allows it to be used in early-stage patients or as an add-on/second-line therapy for

patients who are not well controlled on anti-VEGF injections (~1.3 million DME patients in the U.S. represent the

target market), which we believe could be a value-add to the the treatment paradigm, if approved, supported by our

physician checks. Importantly, OCS-01 may enable earlier disease intervention in DME, potentially expanding both the

patient population and prescribing physician base.

3. We believe the asset is derisked and validated through AbbVie’s Ozurdex, a dexamethasone intravitreal implant

approved for DME. That said, Ozurdex is generally reserved as a later-line option for patients not responding

adequately to VEGF inhibitors. Occasionally, it is administered as an adjunctive therapy to VEGF inhibitors.

4.