US-based Oculis Holding AG (NASDAQ: OCS) has announced positive top-line results from Stage 1 of its Phase III DIAMOND trial for the eye drop drug candidate OCS-01, which is being assessed as a treatment for diabetic macular edema (DME). The trial data indicate that the drug achieved its primary efficacy endpoint with a statistically significant improvement. Stage 2 of the trial is set to commence in the second half of this year.
DIAMOND Trial Design and Stage 1 Outcomes
The DIAMOND trial is a Phase III, two-stage, double-masked, randomized, multi-center trial designed to assess the efficacy and safety of OCS-01 eye drops in DME patients. The primary objective of Stage 1 was to select the optimal dosing regimen. Conducted across 39 sites in the USA and Europe, 148 patients were randomized 2:1 to receive OCS-01 or vehicle, with the treatment arm showing a significant improvement in mean BCVA ETDRS score from baseline to Week 6 versus the vehicle group. This effect was sustained to Week 12, demonstrating the potential efficacy of OCS-01 in treating DME.
OCS-01’s Tolerability and Impact on Visual Acuity
OCS-01 was well-tolerated, with no unexpected adverse events observed. A higher percentage of patients in the OCS-01 group achieved a ≥15-letter improvement in BCVA from baseline compared to the vehicle group, a result that was sustained to Week 12.
DME’s Global Impact and OCS-01’s Potential
Diabetic macular edema is the leading cause of visual loss and legal blindness in patients with diabetes, affecting around 37 million people worldwide. Many patients remain untreated due to a lack of convenient treatment options. OCS-01, leveraging Oculis’ proprietary Optireach technology, is a novel, high concentration topical formulation of dexamethasone designed to address the limitations of conventional eye drops by improving solubility, increasing residence time on the eye surface, and enabling drug passage to the posterior segment of the eye.
Oculis’ Commitment to Ophthalmic Care
Oculis (Nasdaq: OCS) is a global biopharmaceutical company focused on developing innovative product candidates for eye diseases with high unmet needs. Its clinical-stage pipeline includes OCS-01 for DME, OCS-02 for dry eye disease and uveitis, and OCS-05 for acute optic neuritis and other neuro-ophthalmic disorders.-Fineline Info & Tech
