Oculis Announces First Patient Dosed in Phase III DIAMOND Trial of Investigational OCS-01 Eye Drops for Diabetic Macular Edema

HONG KONG, Nov. 16, 2021 /PRNewswire/ -- Oculis SA ("Oculis"), a biopharmaceutical company focused on clinical development, is pleased to announce that the first patient has been dosed in its Phase III clinical study, named DIAMOND, to evaluate the efficacy and safety of OCS-01 in treating diabetic macular edema. Diabetic macular edema is a severe complication of diabetes and a leading cause of vision loss and blindness in people aged 20-65*. Oculis is committed to improving and restoring patients' vision by developing novel ophthalmic treatments.

OCS-01 is a novel, high-concentration, preservative-free dexamethasone formulation (utilizingDissolution Nanoparticle Formulation Technology）Localized eye drop, expected to become the first non-invasive topical eye drop for treating diabetic macular edema. OCS-01 opens up the possibility of using eye drops to treat patients with diabetic macular edema at different clinical stages. Moreover, OCS-01 can provide more treatment options for patients who struggle to afford specialist consultation fees; it is also able to significantly reduce the burden on healthcare systems and improve patient outcomes and quality of life.

OCS-01 Shows Promising Data in Phase II Clinical Trial, First Presented at The Angiogenesis, Exudation, and Degeneration Conference in February 2020. In the Phase IIb clinical trial (DX-211) involving 144 patients, OCS-01 demonstrated improved vision and reduced central macular thickness in patients with diabetic macular edema compared to the control group, while exhibiting good safety.

DIAMOND is a double-blind, randomized, vehicle-controlled, multicenter, multinational Phase III clinical study of OCS-01 for diabetic macular edema. The primary objective is to determine the mean change in Best Corrected Visual Acuity (BCVA) using the "Early Treatment Diabetic Retinopathy Study" (ETDRS) chart — an increase in values indicates improved efficacy. Additionally, this study will evaluate the mean change in macular thickness as measured by Spectral Domain Optical Coherence Tomography (SD-OCT) (Central Subfield Thickness, abbreviated as "CST"), with a reduction in CST indicating improved efficacy.(For more details, please visitwww.clinicaltrials.gov——Identification NumberNCT05066997）

Oculis Member of the Scientific Advisory Board, Director of Ophthalmology at Paris University, M.D.Ramin Tadayoni The professor stated:"Topical eye drops are of great significance for the effective treatment of diabetic macular edema in patients and can provide ophthalmologists with an early treatment option. Although traditional intravitreal injections and steroid implant treatments are effective, they are invasive therapies that require administration by trained specialists. This presents a significant treatment burden for patients, caregivers, and doctors. I believe OCS-01 can offer a more convenient and flexible treatment option, making it more suitable as a first-line early treatment while being compatible with current treatment standards for more severe cases. Undoubtedly, OCS-01 will benefit more diagnosed patients, enabling those who struggle to afford repeated specialist injection costs to continue their treatment and ultimately improve outcomes. If the trial is successful, OCS-01 will bring an important new treatment option to millions of patients with diabetic macular edema who are at high risk of blindness."

Oculis Chief Executive OfficerRiad Sherif Dr. added:"Our team has worked tirelessly to reach this significant milestone in the development of OCS-01, and I couldn't be prouder of them. The initiation of the Phase III DIAMOND study brings us one step closer to offering a novel treatment option for patients with diabetic macular edema, which we hope will improve their vision, provide a more convenient treatment approach, and enhance their quality of life."

Looking ahead, Oculis is poised to achieve several milestone developments, with OCS-01, one of our candidate novel topical ophthalmic drop treatments, marking a solid first step. Other significant research projects expected in the coming months include: initiating a Phase III clinical trial for OCS-01 as a topical treatment for pain and inflammation following anterior segment surgery, and Phase II clinical trials for OCS-02 in the treatment of severe dry eye disease and chronic uveitis, respectively. We also aim to leverage Oculis’ OPTIREACH® technology to expand the pipeline of novel topical drop treatments for both anterior and posterior segment diseases, which could have a profound impact on the management of ophthalmic conditions affecting patients worldwide.

Last month, Oculis's Hong Kong office was officially established to enhance the company's presence in China.MainlandAnd the future development and business capabilities of this important strategic region in Asia. The company also appointed Dr. Joanne Chang, former Global Medical Affairs Head of Ophthalmology at Novartis, as Oculis' Global Chief Medical Officer and Head of Portfolio Management, strengthening the company’s existing operations in China, Europe, and the United States, and supporting the company's global expansion.

About Diabetic Macular Edema (DME）*

Diabetic Macular Edema: A Leading Cause of Vision Loss and Blindness in Diabetic Patients

*www.idf.org