Oculis Holding AG (Nasdaq: OCS) has announced accelerated patient enrollment in both Phase 3 DIAMOND trials for OCS-01 eye drops, a potential novel treatment for diabetic macular edema (DME). The DIAMOND-1 trial has reached approximately 70% of its enrollment target, while DIAMOND-2 has enrolled around 40% of patients. This progress positions Oculis closer to potentially offering the first topical eye drop for DME, a condition currently managed primarily with invasive treatments.
Advancing OCS-01 for DME Treatment
The DIAMOND program includes two Phase 3, double-masked, randomized, multi-center trials designed to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME. OCS-01 is formulated as a high-concentration dexamethasone eye drop using Oculis' OPTIREACH® technology, aiming to deliver the drug effectively to the retina via a non-invasive route. The primary endpoint for both trials is the change in best corrected visual acuity (BCVA ETDRS) letter score at Week 52.
Expert Insight
Dr. Arshad M. Khanani, Chairperson of the DIAMOND Program Steering Committee, noted the promising results from Stage 1 of the DIAMOND Phase 3 program. "Patients treated with OCS-01 experienced significant improvements in visual acuity and a clinically meaningful reduction in macular edema," he stated. Dr. Khanani also expressed optimism about the potential of OCS-01 to become the first non-invasive topical eye drop therapy for DME, offering hope to millions affected worldwide.
The Need for Novel DME Treatments
DME is a leading cause of vision loss and legal blindness in diabetic patients. It is estimated to affect approximately 37 million people globally, with projections indicating a rise to 53 million by 2040. Current treatments often involve intravitreal injections or ocular implants, which are invasive and can be burdensome for patients. A non-invasive topical treatment like OCS-01 could significantly improve patient compliance and quality of life.
Trial Design and Endpoints
Both DIAMOND-1 and DIAMOND-2 trials aim to enroll 350 patients each, randomized 1:1 to receive either OCS-01 or a vehicle control. During the initial 6-week induction phase, the drops are administered six times daily, followed by a maintenance phase with three times daily administration through 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.
Expanding Expertise
Oculis has also expanded its DIAMOND program committees, enlisting globally renowned retina experts to provide strategic oversight. This move underscores the company's commitment to rigorous scientific standards and maximizing the potential for a successful trial outcome.
About OCS-01 and OPTIREACH Technology
OCS-01 leverages Oculis’ OPTIREACH® technology to enhance the solubility of dexamethasone, a lipophilic drug, and increase its residence time on the eye surface. This formulation aims to facilitate the drug's passage from the eye surface to the posterior segment, addressing the limitations of conventional eye drops. OCS-01 is currently an investigational drug and has not received regulatory approval in any country.
