Oculis: Phase 3 study with novel topical eye drop treatment for Diabetic Macular Edema

Oculis S.A., (Oculis) a late-stage biopharmaceutical company focused on developing transformative ophthalmic treatments to improve the sight and lives of patients, today announces that the first patients have been dosed in its Phase 3 DIAMOND trial evaluating the efficacy and safety of OCS-01 in Diabetic Macular Edema (DME) (DIAMOND – DIAbetic Macular edema patients ON a Drop). DME is a major complication of diabetes and is a primary cause of vision loss and blindness in people aged 20 and 65.

OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone (DSNP) that has the potential to be the first topical eye drop and non-invasive treatment for DME. OCS-01 opens up the possibility of treating DME patients at all stages of disease with an eye drop. In addition, OCS-01 could increase the accessibility to treatment of those patients without easy access to specialists; together, this could significantly reduce the burden to the health care system and improve patient outcomes and quality of life.

OCS-01 has been shown to improve visual acuity and reduce central macular thickness in DME patients compared to vehicle and demonstrated a promising safety profile in the 144-patient Phase 2b (DX-211) trial. The positive Phase 2 data were first presented at the Angiogenesis, Exudation, and Degeneration 2020 Conference in February 2020.

The Phase 3 DIAMOND trial is a pivotal, double-masked, randomized, vehicle-controlled, multi-center, multi-country study of OCS-01 in subjects with DME. The primary endpoint of the trial is the mean change in the Best Corrected Visual Acuity “Early Treatment Diabetic Retinopathy Study” chart (BCVA ETDRS) with a numerical increase indicating improvement. The secondary endpoint will assess the mean change in macular thickness (CST, Central Subfield Thickness) measured by SD-OCT (Spectral Domain Optical Coherence Tomography) with a reduction in CST indicating improvement. (more details can be found at www.clinicaltrials.gov – NCT05066997).

Ramin Tadayoni, M.D., Member of Oculis’ Scientific Advisory Board, Professor of Ophthalmology at University of Paris and Head of the Department of Ophthalmology at Lariboisière University Hospital and Rothschild Foundation Hospital (Paris, France) said: “The availability of an effective topical eye drop treatment for DME would be transformational for patients and would provide an earlier treatment option for ophthalmologists. The current therapies, intra-vitreal injections and steroid implants, although efficacious, are all invasive and all require administration by a trained specialist. This represents a significant treatment burden for patients, caregivers and physicians. OCS-01 could offer a much easier and flexible treatment option, which I believe would be more appropriate as a first-line early treatment and which could potentially be used concommittantly with current standard of care for more severe cases. This will undoubtedly expand the proportion of diagnosed patients we treat, increase adherence for patients who cannot afford multiple visits to specialists for injections and, ultimately, improve treatment outcomes. If successful, OCS-01 could bring an important new treatment option to the millions of DME patients who face the serious prospect of losing their vision.”

Riad Sherif, M.D., CEO of Oculis, added: “I am extremely proud of the Oculis team, which has worked diligently to achieve this important development milestone for OCS-01. The initiation of the Phase 3 DIAMOND study means we are a step closer to bringing DME patients a novel treatment that we hope can improve their sight, provide easier access to treatment and enhance their quality of life.

“This is the first of several important development milestones for the innovative topical ophthalmic candidates in our pipeline that we expect in the coming months. Other upcoming milestones include the start of a pivotal Phase 3 trial with OCS-01 as a once-daily treatment for pain and inflammation following surgery at the front of the eye, and Phase 2 trials with OCS-02 in Severe Dry Eye Disease and Chronic Uveitis, respectively. We are also looking to leverage Oculis’ OPTIREACH® technology to expand our pipeline of novel topical agents targeting other front- and back-of -the-eye diseases that have the potential to meaningfully impact the management of ophthalomogic diseases affecting patients around the world.”

About Diabetic Macular Edema (DME)
DME affects 1 in 14 people with diabetes and is the leading cause of visual loss and legal blindness in patients with diabetes. It currently affects more than 28 million people worldwide and, as the prevalence of diabetes increases, is expected to increase to 45 million by 2040. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safer, more effective, longer-lasting and less burdensome treatments for DME patients.