Oculis Completes Enrollment in Phase 3 Trials for OCS-01 Eye Drops in Diabetic Macular Edema
Zug, Switzerland – April 10, 2025 – Oculis Holding AG, a leading biopharmaceutical company specializing in ophthalmic and neuro-ophthalmic diseases, announced the successful completion of enrollment in both Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops for the treatment of Diabetic Macular Edema (DME).
These trials, designed as pivotal registration studies, aim to support global marketing applications, including the submission and approval by the U.S. Food and Drug Administration (FDA).
Trial Details
The trials enrolled over 800 patients at 119 investigative sites throughout the United States and several other countries. OCS-01 is a potential first-in-class, intravitreal anti-inflammatory and vascular endothelial growth factor (VEGF) inhibitor designed for the treatment of DME.
Impact on Patients
For individuals living with Diabetic Macular Edema, this development could mean access to a new treatment option. DME is a complication of diabetes that can result in vision loss and blindness. Current treatments include injections of anti-VEGF agents, which can be costly, inconvenient, and associated with potential side effects. OCS-01, if approved, may offer an alternative, topical treatment that could provide similar efficacy with fewer injections and fewer side effects.
- Potential for fewer injections and less frequent office visits
- Reduced risk of injection-related complications
- Possibility of improved patient compliance due to ease of use
Global Impact
The successful completion of these trials represents a significant step forward in the development of a potential new treatment for DME. With an aging population and increasing prevalence of diabetes, the global burden of this condition is expected to grow. A topical treatment like OCS-01 could help address the unmet medical needs of patients and reduce the overall healthcare costs associated with managing DME.
- Potential to improve patient outcomes and reduce vision loss
- Opportunity to reduce healthcare costs by offering a topical alternative to injectable treatments
- Possibility to expand access to care in underserved areas where access to specialist care is limited
Conclusion
The completion of enrollment in the Phase 3 DIAMOND-1 and DIAMOND-2 trials marks an important milestone for Oculis as they work to bring OCS-01 to market for the treatment of Diabetic Macular Edema. This development not only represents a potential new treatment option for patients but also has the potential to reduce the overall healthcare costs associated with managing this condition. As we await the trial results and regulatory approval, the promise of a topical alternative to injectable treatments brings hope to those living with DME and the healthcare community.
Stay tuned for further updates on this exciting development in the world of ophthalmology.
