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]

Core Insights - Oculis Holding AG has appointed Mark Kupersmith, M.D. as Chief Medical Advisor for Neuro-Ophthalmology and Sebastian Wolf, M.D., Ph.D. as Chief Medical Advisor for Ophthalmology, enhancing its leadership team during a critical phase of development [1][3][4] Company Developments - Oculis has made significant progress in its clinical pipeline, completing enrollment in Phase 3 DIAMOND trials for OCS-01 targeting diabetic macular edema and aligning with the U.S. FDA on a genotype-based development program for Licaminlimab (OCS-02) in dry eye disease [2][4] - Positive topline results were announced for Privosegtor (OCS-05) in acute optic neuritis, marking a pivotal advancement in neuroprotection therapies [2][6] Leadership Expertise - Mark Kupersmith, M.D. brings over 40 years of experience in neuro-ophthalmology, contributing critical expertise to Oculis' expansion into this field, particularly with the advancements in Privosegtor [3][6] - Sebastian Wolf, M.D., Ph.D. is recognized for his extensive background in retina and imaging, which will support the execution of the DIAMOND program and the development of OCS-01 [4][10] Clinical Pipeline - Oculis' pipeline includes three core product candidates: OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease, all addressing significant unmet medical needs [13]