Oculis Completes Patient Enrollment in Phase 1 of Pivotal Phase 3 DIAMOND Trial Evaluating OCS-01 for Diabetic Macular Edema

Evaluation of the Efficacy and Safety of OCS-01 in the Treatment of Diabetic Macular Edema (DME)

Lausanne, SwitzerlandJanuary 5, 2023PR Newswire -- Oculis S.A. ("Oculis"), an international biopharmaceutical company dedicated to improving vision and protecting eyes, today announced the completion of patient enrollment in the first phase of its Phase 3 clinical trial. The trial, named DIAMOND (DIAbetic Macular edema patients ON a Drop), aims to evaluate the efficacy and safety of OCS-01 in patients with diabetic macular edema (DME).

Oculis initiated the Phase 3 clinical trial of DIAMOND in two stages by the end of 2021. This is a randomized, double-blind, placebo-controlled, multinational, multicenter clinical trial studying OCS-01 for the treatment of DME. In both stages, the primary endpoint is the mean change from baseline to Week 6 (Stage 1) and Week 52 (Stage 2) as measured by the "Early Treatment Diabetic Retinopathy Study" Best-Corrected Visual Acuity (BCVA ETDRS) chart. Secondary endpoints include several visual and anatomical parameters, such as the mean change from baseline in central retinal thickness (CST) in the macular region measured by SD-OCT (Spectral-Domain Optical Coherence Tomography). For more details, please visit www.clinicaltrials.gov-NCT05066997.

Utilizing Oculis' Optireach^®Proprietary technology, OCS-01 is a novel topical formulation of high-concentration dexamethasone eye drops, with the potential to become the first eye drop treatment for DME, ushering in non-invasive treatment for DME. Once approved, OCS-01 will set a precedent for DME treatment via eye drops, enabling doctors to provide personalized treatment for patients, thereby maximizing improvements in DME prognosis.

Oculis`, CEO, M.D.,`Riad SherifSay:"I am very happyOculisWe have already completedDIAMONDStudy No.1Patients in stagesEnrollment. This is for usDedicationTeam'sPowerfulProve that they are now focused on completingResearch, and for the estimated2023Released in the middle of the year1Preparing for the interpretation of phase data. This study is part of our efforts to developDMEA key step in developing new and more accessible therapies can helpDoctorImprove patients' vision and enhance their quality of life."

Clinical Professor of Ophthalmology at the Keck School of Medicine, University of Southern California, M.D.,DIAMOND Clinical Trial Principal Investigator David S. Boyer, M.D.Say:"Topical MedicationsTreatmentMethodWillBringSignificant advantages, including earlyInterventionAnd TreatmentAccessibility，Convenience and Non-invasiveness. Currently,OCS-01，Utilized its proprietaryOptireach® Technology, Looks LikeYesAlready inPhase 3 ClinicalThe most promising candidate drug. If approved, it canUsed forDMEEarly IndependenceTreatment, orAdjuvant therapy. This effective eye drop for local treatmentWillAllow doctors to treat earlierDME, andPossibleThroughCompared with the current standardTreatment PlanCombined, toImproveEfficacy or persistenceContinuedSex."

NevadaStateRenoArshad M. Khanani, MD, Principal Investigator of the DIAMOND Clinical Trial and Director of Clinical Research at Sierra Eye Associates, commented:"If successful, OCS-01 will become an important treatment option for patients with DME. As the first topical eye drop and non-invasive treatment for DME, OCS-01WillDiagnosed around the world withPatients with DME benefit, making it faster and easier to access treatment. ThisWillSignificantly reduce the burden on the healthcare system and improve patient outcomes."

Compared with placebo, OCS-01 has been shown to improve vision and reduce macular retinal thickness in patients with DME, demonstrating a good safety profile in a Phase 2b (DX-211) trial involving 144 patients. The Phase 2 clinical trial data were first presented at the "Angiogenesis Exudation, and Degeneration 2020" conference in February 2020 and published in the journal *Acta Ophthalmologica* in June 2022.