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Positive Phase 3 Stage 1 DIAMOND Trial Results of OCS-01 in Diabetic Macular Edema Presented at 23rd EURETINA Congress
OCS-01’s positive results in Stage 1 of the Phase 3 DIAMOND trial for diabetic macular edema (DME) were presented as a late-breaking abstract showing that the
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[{"type":"text","content":"OCS-01’s positive results in Stage 1 of the Phase 3 DIAMOND trial for diabetic macular edema (DME) were presented as a late-breaking abstract showing that the trial met primary and secondary endpoints with robust statistical significanceOn track to commence Stage 2 of the DIAMOND program with two parallel global Phase 3 trialsIf approved, OCS-01 has the potential to become the first topical eye drop for the treatment of DME ZUG, Switzerland and BOSTON, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced that Professor Ramin Tadayoni, M.D., Ph.D., presented the positive results from Stage 1 of the Phase 3 DIAMOND trial of OCS-01 in patients with DME at the 23rd EURETINA congress, which took place October 5-8, 2023 in Amsterdam, the Netherlands. Professor Tadayoni, who also chaired the “Landmarks and Late Breakings” session, presented data from the Stage 1 of the DIAMOND Phase 3 program showing that the trial met primary and secondary endpoints with robust statistical significance, and achieved its objective of confirming the loading and maintenance dose to be tested in Stage 2 of the trial. Specifically, the trial met its primary endpoint, showing a statistically significant improvement in Best Corrected Visual Acuity (BCVA) in patients treated with OCS-01versus vehicle-treated patients at Week 6 (OCS-01: 7.2 letters vs vehicle: 3.1 letters, p=0.007), which was sustained through Week 12 (OCS-01: 7.6 letters vs vehicle: 3.7 letters, p=0.016). For two secondary endpoints, a significantly higher percentage of patients treated with OCS-01 achieved ≥15-letter improvement in BCVA (OCS-01 25.3% vs vehicle: 9.8%, p= 0.015), and patients in the OCS-01 treatment arm also showed significant improvement in retinal thickness as compared to vehicle (OCS-01: -63.6 µm vs vehicle: +5.5 µm, p","length":2408,"tagName":"div"}]