ZUG, Switzerland, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Oculis accelerates its portfolio development with Privosegtor moving into the PIONEER pivotal program in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) following positive FDA meeting OCS-01 DIAMOND Phase 3 trials in diabetic macular edema (DME) remain on track for topline results expected in Q2 2026 Licaminlimab PREDICT-1 registrational trial, the first genotype-based trial to drive precision medicine in dry eye dis ...

Core Insights - Oculis Holding AG is advancing its late-stage portfolio in neuro-ophthalmology and ophthalmology, entering a pivotal phase for growth and innovation [2][9] - The company is set to present at multiple investor conferences in November, highlighting its commitment to engaging with investors [4][5][6][7] Company Developments - Oculis is progressing its Privosegtor program into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION) after a positive meeting with the FDA [2] - Topline results for OCS-01, targeting diabetic macular edema, are expected in Q2 2026 as part of its DIAMOND registrational trials [2] - Licaminlimab is anticipated to enter the PREDICT-1 registrational trial for dry eye disease (DED), marking a significant step in precision medicine [2][9] Financial Position - The company maintains a strong balance sheet and a robust pipeline, positioning it to deliver six pivotal readouts with current funding [3] Upcoming Events - Oculis will participate in the Guggenheim Securities 2nd Annual Healthcare Innovation Conference from November 10-12, featuring a fireside chat with the CEO [4] - The Stifel Healthcare Conference will take place from November 11-13, with another fireside chat scheduled [5] - Management will also engage in one-on-one meetings at the LifeSci Capital and Sofinnova Partners Growth & Innovation Summit on November 17 [6] - A panel discussion featuring the CEO is planned for the ICR Healthcare Conference on November 17 [7]

Core Insights - Oculis Holding AG is advancing its late-stage portfolio in neuro-ophthalmology and ophthalmology, entering a pivotal phase to become a leader in these fields [2][8] - The company is preparing for registrational trials for its key product candidates, including Privosegtor for acute optic neuritis and NAION, with positive feedback from the FDA [2][8] - Oculis has a strong balance sheet and is positioned to deliver six pivotal readouts with current funding, aiming to improve eye care with innovative treatments [3] Upcoming Events - Oculis management will participate in several investor conferences in November, including the Guggenheim Securities Healthcare Innovation Conference and the Stifel Healthcare Conference [4][5] - Riad Sherif, M.D., CEO of Oculis, will engage in fireside chats and panel discussions at these conferences, providing insights into the company's strategies and developments [4][5][7] - The company will also hold one-on-one meetings with investors during these events, facilitating direct engagement [6][7] Product Pipeline - Oculis' late-stage clinical pipeline includes three core product candidates: - Privosegtor, targeting optic neuropathies with broad clinical applications [8] - OCS-01, aiming to be the first non-invasive topical treatment for diabetic macular edema, with topline results expected in Q2 2026 [2][8] - Licaminlimab, a novel anti-TNFα treatment for dry eye disease, developed with a genotype-based approach [2][8]

Core Viewpoint - Oculis Holding AG has announced the pricing of an offering of 5,432,098 ordinary shares at $20.25 per share, aiming to raise a total of $110 million before expenses, to support the development of its neuroprotective clinical candidate, Privosegtor, and for general corporate purposes [1][2]. Group 1: Offering Details - The financing consists of an underwritten offering of 4,691,358 ordinary shares and a registered direct offering of 740,740 ordinary shares, with the total expected to close around November 3, 2025 [3]. - Of the shares being offered, 2,635,801 are new shares issued from the Company's existing capital band, while 3,500,000 are treasury shares [3]. - The issuance of new shares will increase the total number of registered shares authorized by the Company to 57,169,475 [3]. Group 2: Use of Proceeds - The net proceeds from the financing will be utilized to advance the development of Privosegtor for treating acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), along with working capital and general corporate purposes [2]. Group 3: Management and Advisors - J.P. Morgan, Leerink Partners, and Pareto Securities are acting as joint bookrunning managers for the underwritten offering, while Van Lanschot Kempen is the manager and Arctica Finance serves as a financial advisor [4]. Group 4: Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmic conditions, with a late-stage clinical pipeline that includes three core product candidates: Privosegtor, OCS-01, and Licaminlimab [6]. - The company is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team supported by international healthcare investors [6].

Core Insights - Oculis Holding AG is showcasing its innovative late-stage pipeline at Eyecelerator and the American Academy of Ophthalmology (AAO) Annual Meeting, highlighting significant advancements in treatments for ophthalmic diseases [1][2]. Company Developments - The CEO of Oculis, Riad Sherif, will present updates on the late-stage pipeline, including the acceleration of Privosegtor into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy after a positive FDA meeting [2]. - The Phase 3 DIAMOND program for OCS-01 eye drops targeting diabetic macular edema is expected to provide topline readouts in Q2 2026 [2]. - A registrational trial for Licaminlimab in dry eye disease is anticipated to start in Q4 2025, utilizing a genotype-based approach [2]. Industry Context - Oculis is actively participating in multiple events at the AAO, including discussions on the role of eye drops like OCS-01 in treating diabetic macular edema, indicating a shift towards non-invasive treatment options [3][4]. - The company’s pipeline includes Privosegtor, which has shown neuroprotective effects in acute optic neuritis, and OCS-01, which aims to transform treatment paradigms for diabetic macular edema [6][10]. Product Information - Privosegtor is a novel peptoid small molecule candidate with potential applications in neuro-ophthalmic diseases, having received Orphan Drug designation from both the FDA and EMA [6]. - OCS-01 is an investigational high-concentration dexamethasone eye drop designed to treat diabetic macular edema non-invasively, addressing limitations of current treatments that require invasive delivery methods [10][12]. Market Need - There is a significant unmet medical need for effective treatments for conditions like acute optic neuritis and diabetic macular edema, with millions affected globally [8][12].

Core Insights - Oculis Holding AG is showcasing its innovative late-stage pipeline at Eyecelerator and the American Academy of Ophthalmology (AAO) Annual Meeting, highlighting significant advancements in treatments for ophthalmic diseases [1][2]. Company Developments - The CEO of Oculis, Riad Sherif, will present updates on the late-stage pipeline, including the acceleration of Privosegtor into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy after a positive FDA meeting [2]. - The Phase 3 DIAMOND program for OCS-01 eye drops targeting diabetic macular edema is expected to provide topline readouts in Q2 2026 [2]. - A registrational trial for Licaminlimab in dry eye disease is anticipated to start in Q4 2025, utilizing a genotype-based approach [2]. Industry Participation - Oculis will participate in multiple events at the AAO, including Innovate Retina and the Society for Artificial Intelligence in Vision and Ophthalmology (SAIVO), discussing the future of eye drop treatments for diabetic macular edema [3][4]. - The company will also support the COPhy Satellite Symposium during the AAO Annual Meeting [5]. Product Pipeline - Privosegtor is a novel peptoid small molecule candidate showing potential as the first neuroprotective therapy for acute optic neuritis, with positive results from the ACUITY Phase 2 trial indicating neuroprotective effects [7]. - OCS-01 is an investigational high-concentration dexamethasone eye drop designed to treat diabetic macular edema non-invasively, aiming to transform treatment paradigms in this area [11][12]. - Licaminlimab is being developed as a topical anti-TNFα treatment for dry eye disease, currently in Phase 2 trials [14]. Market Context - Diabetic macular edema affects approximately 37 million people globally, with projections indicating an increase to 53 million by 2040, highlighting the urgent need for effective treatments [13]. - Acute optic neuritis and non-arteritic anterior ischemic optic neuropathy represent significant unmet medical needs, with no approved therapies currently available [9][10].

Privosegtor Development and Clinical Trials - Privosegtor is advancing to registrational programs in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)[8] - PIONEER-1 registrational trial for AON is scheduled to start in Q4 2025[9, 16] - PIONEER-2 registrational trial for AON is scheduled to start in 1H 2026[9, 16] - PIONEER-3 registrational trial for NAION is scheduled to start in mid-2026[9, 16] - The registrational trials PIONEER-1 and PIONEER-2 in AON will enroll 140-160 patients[17] Market Opportunity and Potential - The overall portfolio has a significant market potential of approximately $25 billion[8] - The U S market potential for Acute Optic Neuritis (AON) is estimated to be over $3 billion, with an incidence of over 30,000 patients per year[30, 31] - The U S market potential for Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) is estimated to be over $4 billion, with an incidence of over 30,000 patients[43, 45] Oculis' Strategy and Pipeline - Oculis plans to cross-reference the Privosegtor AON IND for a new IND submission in MS Relapses in 2026[15, 50] - OCS-01 eye drops are in registrational trials with readouts anticipated in Q2 2026, potentially as the first non-invasive treatment for DME[8, 50] - Oculis has a strong balance sheet with no debt and a cash runway into 2H 2027 without utilizing the loan facility[8]