DIAMOND-1 Phase 3 trial, assessing the efficacy and safety of OCS-01 eye drops following 52 weeks of treatment in Diabetic Macular Edema (DME) patients, was initiated as plannedStage 1 results showed superiority of OCS-01 eye drops vs. vehicle with robust statistical significance with no unexpected adverse events observedSecond 52 weeks Phase 3 trial of OCS-01 in DME, DIAMOND-2, is anticipated to start in Q1 2024If approved, OCS-01 has the potential to become the first topical eye drop and non-invasive treatment option for DME ZUG, Switzerland, and BOSTON, Dec.

DIAMOND-1 3期试验旨在评估OCS-01滴眼液在糖尿病性黄斑水肿（DME）患者中治疗52周后的疗效和安全性，该试验已启动，因为计划的第一阶段结果显示OCS-01滴眼液与载体相比具有强大的统计学显着性，没有观察到意外的不良事件OCS-01在DME，DIAMOND-2，预计将于2024年第1季度开始，如果获得批准，OCS-01有可能成为瑞士祖格和12月波士顿DME的第一个局部滴眼液和非侵入性治疗选择。

18, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces First Patient First Visit (FPFV) in Stage 2 of its Phase 3 DIAMOND-1 trial evaluating Oculis’ lead product candidate OCS-01 for the treatment of DME, a leading cause of preventable blindness in working-age adults affecting approximately 37 million people worldwide.

182023年（环球通讯社）--Oculis Holding AG（纳斯达克：OCS）（“Oculis”）是一家旨在挽救视力和改善眼部护理的全球生物制药公司，在其第三阶段DIAMOND-1试验的第二阶段宣布首次患者首次就诊（FPFV），该试验评估了Oculis的主要候选产品OCS-01治疗DME，这是影响全世界约3700万人的工作年龄成年人可预防失明的主要原因。

DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients. The primary objective of the 3-month Stage 1 was to select the optimal dosing regimen (n=148). OCS-01 achieved the primary endpoint with robust statistical significance showing improvement in Best Corrected Visual Acuity (BCVA) vs.

DIAMOND-1（糖尿病性黄斑水肿患者滴眼液）是一项3期，两阶段，双盲，随机，多中心试验，用于评估OCS-01滴眼液在DME患者中的疗效和安全性。3个月第一阶段的主要目标是选择最佳给药方案（n=148）。OCS-01达到了主要终点，具有强大的统计学意义，显示最佳矫正视力（BCVA）与。

vehicle at Week 6 following the induction phase (OCS-01: 7.2 letters vs. vehicle: 3.1 letters, p=0.007). The effect was sustained to Week 12 with the maintenance dose. Furthermore, 27.4% of patients in the OCS-01 group achieved ≥15-letter improvement in BCVA from baseline vs. 7.5% in the vehicle group at Week 12 (p=0.009).

诱导阶段后第6周的载体（OCS-01:7.2个字母与载体：3.1个字母，p=0.007）。维持剂量的作用持续到第12周。此外，OCS-01组中27.4%的患者在第12周时BCVA从基线改善≥15个字母，而载体组为7.5%（p=0.009）。

A statistically significant decrease .

统计上显着的下降。