Oculis Announces Upcoming Presentation of Positive Stage 1 Top Line Results from Phase 3 DIAMOND Trial at Clinical Trials at the Summit (CTS)
ZUG, Switzerland, and BOSTON, USA, May 31, 2023 – Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces that Arshad M Khanani, MD, MA, Co-Principal Investigator for Oculis’ Phase 3 DIAMOND trial and member of Oculis’ Scientific Advisory Board, will present the Stage 1 top line results of OCS-01 eye drops in DME in the “First-Time Results of Clinical Trials’ session at Clinical Trials at the Summit (CTS), on June 10, 2023.
Dr Khanani, who is Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor at University of Nevada, Reno School of Medicine, will speak about Oculis’ recently completed Stage 1 of its Phase 3 DIAMOND trial, exploring the potential of OCS-01 eye drops in Diabetic Macular Edema (DME).
Arshad M. Khanani, M.D., M.A, Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor at University of Nevada, Reno School of Medicine, Reno, Nevada and Co-Principal Investigator for the DIAMOND trial, commented: “I feel privileged to be presenting the clinically meaningful Stage 1 top line results to my retina colleagues and to initiate discussions on how a topical treatment, such as OCS-01 eye drops, could change our current treatment paradigm, if approved.”
In Stage 1, OCS-01 met primary and secondary endpoints with robust statistical significance, validating the loading and maintenance dosing regimen designed to optimize OCS-01 efficacy potential. Stage 2 of the trial, which is expected to commence in the second half of this year, includes two global trials, each enrolling approximately 350-450 patients.
Riad Sherif M.D., CEO of Oculis, said: “I would like to thank the organizer of Clinical Trials at the Summit for including the presentation of the DIAMOND Stage 1 results into its prestigious program. It is the perfect event to introduce these results to the retina community given its timing and most importantly, its esteemed audience. We look forward to the discussions with world-renowned retina experts following Dr. Khanani’s presentation.”
Clinical Trials at the Summit brings together a diverse group of experts from around the world to discuss ongoing clinical trials and the latest data, focused on advancements in vitreoretinal care.
For more information on Clinical Trials at the Summit and to register for the event, visit https://www.ctsretina.org/
About OCS-01 eye drops and the OPTIREACH® technology
Leveraging Oculis’ proprietary Optireach® technology, OCS-01 is a novel, high concentration (15 mg/ml), topical formulation of dexamethasone. It is developed to reach the retina via an eye drop, a route of administration for DME that is in contrast with currently available therapies, all requiring the use of more invasive treatments such as ocular implants or intravitreal injections to deliver the medication to the retina. The Optireach® solubilizing 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.
About Diabetic Macular Edema (DME)
DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 20401,2. 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.
Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’ highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and 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. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Europe, and China, Oculis’ goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Corey Davis, PhD
Consilium Strategic Communications
Amber Fennell, Tracy Cheung, David Daley
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This press release contains forward-looking statements and information. For example, statements regarding expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; and the timing or likelihood of regulatory filings and approvals, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F, and any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.