Oculis is a global biopharmaceutical company (Nasdaq: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to deliver life-changing treatments to patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.
Diabetic Macular Edema (DME), a leading cause of blindness in working-age adults, is estimated to affect around 37 million people worldwide, with a significant number of patients left untreated due to a lack of pre-invasive treatment options.
World-renowned retina experts David S. Boyer, MD, Los Angeles, California, Arshad M. Khanani, MD, Reno, Nevada, and Ramin Tadayoni, MD, PhD, Paris, France, discuss the importance for pre-invasive treatment options which could enable earlier intervention, and the positive Stage 1 results from Oculis’ Phase 3 DIAMOND trial of OCS-01 eye drops in DME.
David S. Boyer, MD, PhD, Arshad M. Khanani, MD, and Ramin Tadayoni, MD, discuss the need for pre-invasive treatment options to manage patients with newly diagnosed diabetic macular edema (DME) many of whom currently go untreated. They explain the benefits and challenges of using invasive intravitreal injections, the current standard of care to treat DME, and highlight the potential of OCS-01 eye drops, currently in Phase 3 development, to shift the treatment paradigm to an earlier intervention and provide an additional treatment option in the form of an eye drop for suboptimal responders to help control the disease.
Ramin Tadayoni, MD, PhD, describes DME as the leading cause of preventable blindness in working-age people, explaining how the current treatment landscape leaves many patients untreated due to the challenges of invasive intravitreal injections. He stresses the importance of developing new, non-invasive treatments so physicians can treat DME at an earlier stage and to have an additional treatment option for suboptimal responders to the current standard of care.
Arshad M. Khanani, MD, discusses the positive, robust, and statistically significant Stage 1 results of the DIAMOND trial, a Phase 3, double-masked, randomized, multicenter trial evaluating the efficacy and safety of OCS-01 eye drops for the treatment of DME. Dr. Khanani explains how the novel topical formulation met its primary endpoint, showing improvement in visual acuity and a rapid reduction of macular edema as measured by OCT.
David S. Boyer, MD, shares his overall impressions of the Stage 1 results of the DIAMOND Phase 3 trial in patients with DME treated with OCS-01 eye drops, and what these results could mean to shift the paradigm of current clinical practice. He furthermore discusses the safety profile of OCS-01 and what he anticipates for Stage 2 of the DIAMOND trial. He emphasizes the benefits of treating DME patients with a topical eye drop at a much earlier stage, and patients’ preference for non-invasive treatment options.
OCS-01 is an investigational drug and has not received regulatory approval for commercial use in any country. Some of the statements in the video reflect experts’ perception of the results from the Stage 1 of the phase 3 DIAMOND clinical trial in DME and some of the forward-looking statements reflect their opinion on potential future use of OCS-01 based on their clinical experience.