Core Insights - Oculis Holding AG is set to present results from its late-stage clinical trials, including the Phase 2 ACUITY trial for Privosegtor (OCS-05) and expanded data from the Phase 3 DIAMOND program for OCS-01 eye drops, at several upcoming ophthalmology conferences [1][2][3] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a late-stage clinical pipeline that includes OCS-01 for diabetic macular edema (DME) and Privosegtor for acute optic neuritis [22] Clinical Trial Highlights - The Phase 2 ACUITY trial for Privosegtor (OCS-05) demonstrated clinically meaningful visual function improvement and anatomical neuroprotection in patients with acute optic neuritis, indicating potential applications in various retinal and neurological conditions [3][19] - The Phase 3 DIAMOND program for OCS-01 eye drops aims to evaluate efficacy and safety in DME patients, with over 800 patients enrolled across two pivotal trials [18] Upcoming Presentations - Oculis will present at the Ophthalmology Futures Retina Forum and the EURETINA Congress, with specific sessions focusing on the efficacy and safety outcomes of OCS-01 in DME, highlighting its potential benefits for different patient profiles [2][9][10] Awards and Recognition - The annual Ramin Tadayoni Award, established by EURETINA in partnership with Oculis, will be announced during the EURETINA opening ceremony, recognizing outstanding postgraduate scholars in retinal disease research [4]

Financial Data and Key Metrics Changes - The company reported USD 206 million in cash on hand as of March, with no debt, providing a runway into early 2028 [4] - The company aims to file for NDA in the second half of next year if Phase III trial results are positive [15] Business Line Data and Key Metrics Changes - OCS-one, targeting diabetic macular edema (DME), showed a 7.2 letter gain in BCVA at week six, increasing to 7.6 at week twelve, with 25.3% of patients gaining 15 letters or more at week six, improving to 27.4% at week twelve [10] - Privel Sector for acute optic neuritis achieved a 43% reduction in retinal ganglion cell thickness at month three, maintained to month six, and an 18 letters improvement in low contrast visual acuity compared to placebo [21] - Lickminumab for dry eye disease demonstrated a negative 0.12 in inferior corneal staining, outperforming Xiidra, with six times better results for patients with TNFR1 genotype [32] Market Data and Key Metrics Changes - The addressable market for DME in the U.S. is estimated at 1.3 million patients, with only 0.5 million currently treated [14] - The market for acute optic neuritis has no approved neuroprotective therapies, indicating a significant opportunity for Privel Sector [18] - The potential market for multiple sclerosis is large, with 2.8 million affected worldwide and 170,000 estimated relapses per year in the U.S. [24] Company Strategy and Development Direction - The company is expanding its pipeline beyond ophthalmology into neuro ophthalmology, targeting large unmet needs with innovative products [33] - The strategy includes being the first-line treatment for early intervention in DME and addressing inadequacies in current treatments [13][15] - Plans to meet with the FDA to discuss registrational studies for acute optic neuritis and to advance investigational trials for new indications [28] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet needs in the ophthalmic and neuro-ophthalmic markets, emphasizing the potential for their innovative treatments to fill these gaps [33] - The company is well-positioned to generate multiple value catalysts in the coming quarters, with ongoing trials and expected results [33] Other Important Information - The company has completed patient enrollment for its Phase III trials for OCS-one, with results expected in Q2 of 2026 [12] - The management team is experienced and supported by leading international healthcare investors [4] Q&A Session All Questions and Answers Question: What are the next steps for the Privel Sector? - The company is moving full steam ahead on the investigational program for acute optic neuritis and adding two new indications: acute relapses in multiple sclerosis and NAION [23][28]

Core Insights - Oculis Holding AG will host an R&D Day on April 15, 2025, to provide updates on its clinical candidates and future development strategies [1][2][3] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases, with a pipeline that includes OCS-01 for diabetic macular edema (DME), Licaminlimab for dry eye disease (DED), and Privosegtor for acute optic neuritis [16] Clinical Development Updates - The R&D Day will feature updates on the Phase 3 DIAMOND trials for OCS-01 eye drops in DME, the development plan for Licaminlimab in DED, and expanded data from the ACUITY Phase 2 trial for Privosegtor [2][3] - OCS-01 is a high concentration dexamethasone eye drop aimed at providing a non-invasive treatment for DME, addressing limitations of current invasive treatments [4][5] - Licaminlimab is an anti-TNFα eye drop candidate showing positive effects in Phase 2 trials for DED, with a genetic biomarker identified for improved response [9][10] - Privosegtor has shown neuroprotective benefits in acute optic neuritis, with orphan drug designation from both the FDA and EMA [13][14] Market Need and Impact - DME affects approximately 37 million people globally, with projections to rise to 53 million by 2040, highlighting the urgent need for effective treatments [6][8] - DED impacts over 110 million people in G7 countries, with a significant unmet need as 87% of chronic patients remain unsatisfied with current treatments [11][12] - Acute optic neuritis affects up to 8 in 100,000 people and currently lacks specific neuroprotective therapies, indicating a substantial market opportunity for Privosegtor [15]