Oculis Speeds Up DIAMOND Phase 3 Trials Enrollment for OCS-01 in Diabetic Macular Edema and Expands Program Committees

Oculis Holding AG, a prominent biopharmaceutical firm dedicated to advancing eye care, has announced significant strides in patient enrollment for its Phase 3 DIAMOND trials involving OCS-01 eye drops aimed at treating diabetic macular edema (DME). The company also revealed the expansion of the DIAMOND program committees to include globally recognized retina experts.

Since the end of Q2 2024 through early October, Oculis has enrolled approximately 70% of the patients required for the Phase 3 DIAMOND-1 trial and about 40% for the Phase 3 DIAMOND-2 trial. These trials are integral parts of the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, which comprises two Phase 3, double-masked, randomized, multi-center studies evaluating the efficacy and safety of OCS-01 eye drops in DME patients.

Dr. Arshad M. Khanani, the Chairperson of the DIAMOND Program Steering Committee, expressed his enthusiasm about leading the committee, which includes leading global experts. He highlighted that the initial results from the Phase 3 DIAMOND program are promising, with patients treated with OCS-01 showing significant improvements in visual acuity and reductions in macular edema. Dr. Khanani emphasized the potential of OCS-01 to be the first non-invasive topical eye drop therapy for DME, offering hope to millions affected by the condition worldwide.

Oculis' CEO, Dr. Riad Sherif, expressed satisfaction with the rapid patient enrollment in the DIAMOND-1 and DIAMOND-2 trials, noting that it has exceeded expectations. He also acknowledged the esteemed global experts who have joined the expanded DIAMOND program committees, appreciating their invaluable expertise as the company continues to advance the DIAMOND program.

The DIAMOND program committees consist of numerous world-renowned experts who provide strategic oversight as Oculis develops OCS-01. These experts include Drs. Arshad Khanani, David Almeida, Mark Barakat, Kirk Bateman, David Boyer, Margaret Chang, Saradha Chexal, Carl Danzig, Dilsher Dhoot, Diana Do, Frank Holz, Baruch D. Kuppermann, Timothy Lai, Anat Loewenstein, Sabri Markabi, Patricio Schlottmann, Ashish Sharma, Veeral Sheth, Michael Singer, and Thomas Wolfensberger.

OCS-01 is an investigational eye drop formulated using Oculis’ proprietary OPTIREACH® technology. It is a high-concentration dexamethasone eye drop, designed to treat the retina through topical administration. This method contrasts with existing treatments that require invasive approaches, such as intravitreal injections or ocular implants. The OPTIREACH® technology enhances the solubility of lipophilic drugs, prolonging their presence on the eye's surface and facilitating drug passage to the eye's posterior segment.

The Phase 3 DIAMOND trials aim to enroll 350 patients in each trial. These trials will randomly assign participants to receive either OCS-01 or a placebo six times daily during a 6-week induction phase, followed by three times daily for a 52-week maintenance phase. The primary endpoint is the change in visual acuity, measured by the best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52. Secondary endpoints include the percentage of patients achieving a ≥15-letter gain in BCVA and changes in central subfield thickness (CST) at Week 52. The trials are based on positive findings from the initial stage of the DIAMOND program, announced in the second quarter of 2023.

Diabetic macular edema (DME) is a leading cause of vision loss and legal blindness in diabetic patients, currently affecting around 37 million people globally. This number is expected to rise to 53 million by 2040 due to the increasing prevalence of diabetes. DME results from high blood sugar levels damaging the retina's nerves and blood vessels, leading to fluid accumulation in the retina. There remains a significant need for safer, more effective, and less burdensome treatments for DME patients.

Oculis, headquartered in Switzerland with operations in the U.S. and Iceland, aims to improve the health and quality of life of patients worldwide through its innovative product pipeline. This includes OCS-01 for DME and post-cataract surgery inflammation and pain, licaminlimab (OCS-02) for dry eye disease and non-infectious anterior uveitis, and OCS-05 for acute optic neuritis. Led by an experienced management team, Oculis is supported by leading international healthcare investors.