Oculis announces first patient first visit in Phase 3 DIAMOND-1 trial of OCS-01 eye drop in diabetic macular edema

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Oculis Holding AG announced the First Patient First Visit (FPFV) in Stage 2 of its Phase 3 DIAMOND-1 trial evaluating Oculis’ lead product candidate OCS-01 for the treatment of DME, a leading cause of preventable blindness in working-age adults affecting approximately 37 million people worldwide.

According to the company, DIAMOND-1 is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients. The key objective of the 3-month Stage 1 was to select the optimal dosing regimen (n=148). OCS-01 achieved the primary endpoint with robust statistical significance showing improvement in Best Corrected Visual Acuity (BCVA) vs vehicle at Week 6 following the induction phase (OCS-01: 7.2 letters vs. vehicle: 3.1 letters, p=0.007). The effect was sustained to Week 12 with the maintenance dose.¹

Furthermore, 27.4% of patients in the OCS-01 group achieved ≥15-letter improvement in BCVA from baseline vs. 7.5% in the vehicle group at Week 12 (p=0.009). A statistically significant decrease in Central Subfield Thickness (CST) was also observed. In Stage 1, OCS-01 was well-tolerated with no unexpected adverse events observed.¹

Moreover, the company noted in its news release the second stage of the trial aims to enroll 350 to 400 patients who will be randomized 1:1 to receive OCS-01 or vehicle 6 times daily for a 6-week induction phase and then 3 times daily for a subsequent 46-week maintenance phase. The endpoints for Stage 2 will be the same as in Stage 1 and evaluated at Week 52.

Riad Sherif, MD, CEO of Oculis, pointed out that 2023 has been a remarkable year for the company with the achievement of multiple key milestones and timely execution of our development plans.

“A few weeks ago, we announced the initiation of the RELIEF Phase 2b Trial with OCS-02 in Dry Eye Disease and have now reached another key development milestone with the initiation of the Stage 2 of the Phase 3 DIAMOND-1 trial with OCS-01 in DME. OCS-01 is a promising clinical candidate that has already demonstrated its potential to treat both front and back of the eye indications with the positive results from Stage 1 of the DIAMOND trial in DME and the Phase 3 OPTIMIZE trial in inflammation and pain following cataract surgery,” Sherif said in the news release. “If approved, OCS-01 could become the first eye drop for DME and potentially transform the current treatment paradigm.”

Arshad M. Khanani, MD, MA, FASRS, co-principal investigator for the DIAMOND trial; Oculis Scientific Advisory Board member; Director of Clinical Research at Sierra Eye Associates and clinical associate professor at the University of Nevada, Reno School of Medicine, pointed out the treatment of DME with repeated intravitreal injections results in a significant burden for patients.

“As a field, we have been actively seeking non-invasive alternatives to address DME, aiming to intervene earlier and alleviate treatment burden. OCS-01 eye drops have emerged as a potential solution for this unmet need, and the encouraging results from Stage 1 of the DIAMOND-1 Phase 3 trial support this outlook,” Khanani said in the news release. “The initiation of Stage 2 of the DIAMOND-1 study marks a crucial advancement in the development of OCS-01, positioning it as a promising non-invasive treatment option for patients with DME.”

About OCS-01 eye drops and the OPTIREACH® technology

Leveraging Oculis’ OPTIREACH technology, OCS-01 is a novel, high-concentration (15 mg/ml), topical formulation of dexamethasone. The company noted in its news release it was developed to reach the retina via an eye drop, a route of administration for DME that contrasts with currently available therapies, all requiring invasive delivery to the retina such as ocular implants or intravitreal injections.

According to the company, OPTIREACHsolubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye.

Reference:

1. Oculis Announces First Patient First Visit in Phase 3 DIAMOND-1 Trial of OCS-01 Eye Drop in Diabetic Macular Edema | Oculis. Oculis. Published 2023. Accessed December 19, 2023. https://investors.oculis.com/news-releases/news-release-details/oculis-announces-first-patient-first-visit-phase-3-diamond-1