First patients have been dosed in Oculis’ Phase 3 DIAMOND trial evaluating the efficacy and safety of OCS-01 in Diabetic Macular Edema (DME). 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 trial.
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.
Riad Sherif, M.D., CEO of Oculis, commented: “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.”
(Press release / SK)
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