Key Takeaways

  • Oculis has completed the final patient visit in its phase 3 DIAMOND trials for OCS-01, with topline results expected in June 2026
  • OCS-01 is a potential first-in-class, noninvasive eye drop for diabetic macular edema, aiming to reduce reliance on injections 
  • The company is targeting a potential NDA submission in Q4 2026

Oculis announced it has completed the final patient visit in its phase 3 DIAMOND program evaluating OCS-01 eye drops for diabetic macular edema (DME). The company expects to report topline results in June 2026.

The milestone marks a step forward for OCS-01, an investigational noninvasive therapy that could potentially transform the current treatment landscape for DME.

“The completion of the last patient visit in both DIAMOND phase 3 trials represents a pivotal milestone as we advance towards anticipated topline results in June,” said Riad Sherif, MD, Chief Executive Officer of Oculis. “This achievement reflects our commitment to advancing OCS-01 as a potential first-in-class eye drop therapy for DME.”

Dr. Sherif added that Oculis continues to build momentum across its broader pipeline, highlighting upcoming milestones from its late-stage programs, including the PIONEER registrational study of Privosegtor in optic neuropathies and the PREDICT-1 trial of Licaminlimab, which aims to advance precision medicine in dry eye disease.

The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consists of two phase 3, double-masked, randomized, multicenter trials evaluating the efficacy and safety of OCS-01 over 52 weeks of treatment. Both trials were initiated following positive results from Stage 1 of the program, where patients receiving OCS-01 demonstrated meaningful improvements in visual acuity and rapid reductions in retinal edema.

Oculis plans to release topline data from both trials in June, with a potential new drug application (NDA) submission targeted for the fourth quarter of 2026.

OCS-01 uses Oculis’ proprietary OPTIREACH technology to enable high concentrations of dexamethasone to reach the retina via a topical eye drop. Unlike existing treatments—which rely on intravitreal injections or implants—this approach aims to provide a noninvasive option that can be used earlier in the disease and potentially in combination with other therapies.

OCS-01 remains an investigational therapy and has not yet received regulatory approval in any country.