Core Insights - Oculis Holding AG reported positive topline results for the Phase 2b RELIEF trial of OCS-02 (licaminlimab), indicating potential for the first precision medicine in Dry Eye Disease (DED) [1][3] - The Phase 2 ACUITY trial of OCS-05 in acute optic neuritis (AON) is on track for topline readout in Q4 2024 [1][4] - A pre-NDA meeting with the FDA was completed in August for OCS-01, with NDA submission anticipated in Q1 2025 [1][6] Clinical Highlights - OCS-01 for DME: Patient enrollment in Phase 3 DIAMOND trials exceeded expectations, reaching 35% for DIAMOND-1 and 23% for DIAMOND-2 by the end of June 2024 [4] - OCS-02 (licaminlimab) in DED: Positive results from the Phase 2b RELIEF trial showed improvements in multiple regulatory efficacy endpoints, particularly in patients with the TNFR1 genetic biomarker [4][3] - OCS-05 in AON: Enrollment in the Phase 2 ACUITY trial is complete, with topline readout expected in Q4 2024 [4][6] Financial Highlights - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $131.2 million, an increase from $109.0 million as of December 31, 2023 [7] - Research and development expenses for Q2 2024 were $18.2 million, up from $6.9 million in Q2 2023, primarily due to increased clinical trial expenses [7][8] - The net loss for Q2 2024 was $23.0 million, compared to $14.3 million in Q2 2023, driven by higher clinical development costs [7][8] Corporate Developments - The company raised $59 million in an oversubscribed registered direct offering and listed on the Nasdaq Iceland Main Market [5] - New appointments to the Board of Directors and Scientific Advisory Board aim to strengthen the company's development and commercial expertise [5] - The company plans to consult with the FDA in Q1 2025 regarding the OCS-02 (licaminlimab) program in DED [6]

ZUG, Switzerland, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Reported positive topline results for the Phase 2b RELIEF trial of OCS-02 (licaminlimab) paving the way for potentially the first precision medicine in Dry Eye Disease (DED) Phase 2 ACUITY trial of OCS-05 in acute optic neuritis (AON) is on track for topline readout in Q4 2024 Pre-NDA meeting with U.S. Food and Drug Administration (FDA) completed in August for once daily OCS-01 for the treatment of post-operative inflammation and pain following ocular surg ...

Company Overview - Oculis is a global biopharmaceutical company focused on saving sight and improving eye care [3] - The company has a differentiated pipeline with multiple innovative product candidates, including OCS-01 for diabetic macular edema and post-cataract surgery inflammation, licaminlimab (OCS-02) for dry eye disease and non-infectious anterior uveitis, and OCS-05 for acute optic neuritis [3] - Oculis is headquartered in Switzerland and operates in the U.S. and Iceland, aiming to enhance the health and quality of life for patients globally [3] Management and Events - Riad Sherif, M.D., the CEO of Oculis, will participate in a panel discussion on "Derisked Late-stage Candidates for Retinal Disorders" on August 15, 2024 [2] - A virtual company presentation will also be available on-demand on the same date [2] - Oculis management will participate in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference [4]

ZUG, Switzerland, June 27, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (NASDAQ:OCS, XICE: OCS))) ("Oculis" or the "Company"), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces, in collaboration with EURETINA, the Ramin Tadayoni Award. "Prof. Ramin Tadayoni was an exceptional friend and a highly accomplished and world-renowned retina specialist that, as an advisor, played a key part in Oculis progress since its inception, and most recently as its Chief Scient ...

ZUG, Switzerland, June 27, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) ("Oculis" or the "Company"), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces, in collaboration with EURETINA, the Ramin Tadayoni Award. "Prof. Ramin Tadayoni was an exceptional friend and a highly accomplished and world-renowned retina specialist that, as an advisor, played a key part in Oculis progress since its inception, and most recently as its Chief Scienti ...

ZUG, Switzerland, June 10, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) ("Oculis"), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced positive topline results from its Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED). For the full trial population (n=122): Treatment effect favoring licaminlima ...

Improvements in multiple sign efficacy endpoints were observed in full population and with predictive and more pronounced effects in the TNFR1 genetic biomarker population as identified in prior successful Phase 2 symptoms trial Rapid treatment effect on corneal inflammation was observed in TNFR1 genetic biomarker patients as early as Day 15 and was statistically significant at final efficacy visit on Day 43 Licaminlimab was well tolerated similar to vehicle Company plans to finalize Phase 3 development pla ...

ZUG, Switzerland, June 04, 2024 (GLOBE NEWSWIRE) -- The attached notifications relate to the annual equity incentive awards granted to directors of the Company, as well as the one-time equity incentive awards issued to new directors upon their election to the board of directors of the Company. Attachments ...

ZUG, Switzerland, May 30, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) ("Oculis" or the "Company"), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced the results from its 2024 Annual General Meeting held on May 29, 2024 at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, at 3:30 p.m. CEST, including election of new members to its Board of Directors, as well as the recent appointment of two new members to its Scientific Advis ...

Ms. Sylvia Cheung, CFO sylvia.cheung@oculis.com The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which was filed with the U.S. Securities and Exchange Commission along with a prospectus supplement. Please refer to the Company's SEC filings here and here, each dated May 8, 2024, for more details. These filings can be accessed through the Company's website. For more information, please visit: http: ...