Oculis' DIAMOND Phase 3 in Diabetic Macular Edema at Innovate Retina and Eyecelerator 2024

Oculis Holding AG (Nasdaq: OCS), a global biopharmaceutical company dedicated to eye care innovations, recently announced significant updates on its DIAMOND Phase 3 program for OCS-01, a high concentration dexamethasone eye drop formulated with OPTIREACH® technology. The update will be presented by Dr. David Eichenbaum at the Innovate Retina conference. Additionally, Oculis’ CEO, Dr. Riad Sherif, will present at Eyecelerator 2024, ahead of the American Academy of Ophthalmology Annual Meeting.

Dr. Eichenbaum's presentation will discuss the promising results from Stage 1 of the DIAMOND Phase 3 program, showcasing the efficacy of OCS-01 in treating diabetic macular edema (DME) at the 12-week mark. The design of Stage 2, which aims to further evaluate the safety and efficacy of the eye drops at 52 weeks, will also be outlined. Both DIAMOND-1 and DIAMOND-2 trials are progressing, with a goal to enroll 350 patients each.

Dr. Sherif's presentation will highlight upcoming milestones, including the anticipated top-line results from the ACUITY Phase 2 trial with OCS-05 for acute optic neuritis, expected before the end of 2024.

David Eichenbaum, M.D., a renowned ophthalmologist specializing in retina diseases and surgery, has been involved in over 90 clinical trials and has published extensively in the field. He has a significant role in research and advisory boards, making him a key figure in the development of treatments for retinal conditions.

The Innovate Retina conference focuses on advancements in medical and surgical retina care. It covers a wide range of topics, including management of age-related macular degeneration (AMD), diabetic retinopathy, ocular imaging, gene therapy, ocular oncology, and the latest in retinal pharmacotherapy.

The Eyecelerator conference, held in partnership with the American Academy of Ophthalmology and the American Society for Cataract and Refractive Surgery, highlights industry advancements and innovative products in eye care.

OCS-01 uses Oculis’ OPTIREACH® technology, which enhances the solubility of drugs, increases their residence time on the eye surface, and facilitates the passage of the drug to the posterior segment of the eye. This non-invasive eye drop formulation aims to offer a significant advancement over current DME treatments that require invasive methods like intravitreal injections or ocular implants.

The DIAMOND Phase 3 trials aim to confirm the efficacy and safety of OCS-01. The primary endpoint is the change in best corrected visual acuity (BCVA) at week 52, with secondary endpoints including the percentage of patients with a significant gain in BCVA and changes in central subfield thickness (CST).

Diabetic macular edema (DME) is a leading cause of vision loss among diabetics, affecting millions worldwide. This condition arises from high blood sugar levels damaging the nerves and blood vessels in the retina. Currently available treatments are often invasive and burdensome, highlighting the need for more effective and safer options like OCS-01.

OCS-05, another product in Oculis’ pipeline, is being evaluated for its potential to protect nerve axons in acute optic neuritis and other neuro-ophthalmic diseases. This investigational drug, showing promise in animal models, is currently in a Phase 2 trial, with results expected by the end of the year.

Acute optic neuritis (AON) is a rare condition that can lead to significant vision loss. It often presents as the first sign of multiple sclerosis and primarily affects young adults. The inflammation damages the optic nerve's myelin sheath, leading to permanent visual impairment if not adequately treated.

Oculis, headquartered in Switzerland, with operations in the U.S. and Iceland, is committed to improving eye care through its innovative product pipeline. The company’s management team brings extensive experience and a proven track record in the biopharmaceutical industry, supported by leading international healthcare investors.