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Oculis Holding (OCS) investor relations material
Oculis Holding Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Status Update summary6 Oct, 2025
Pipeline and Regulatory Progress
Achieved full FDA alignment to advance Privosegtor into registration trials for acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), using a single IND for both indications.
PIONEER-1 (AON) to start in Q4 2025, PIONEER-2 (AON) in H1 2026, and PIONEER-3 (NAION) in mid-2026, all mirroring the successful phase II ACUITY trial design.
Privosegtor has received Orphan Drug designation from both FDA and EMA for AON.
Plans to cross-reference Privosegtor AON IND for a new IND submission in MS relapse in 2026.
OCS-01 for DME is in a phase III registration trial with readout expected in Q2 2026; company maintains a strong balance sheet with cash runway into end of 2027.
Clinical Trial Design and Endpoints
PIONEER-1 and -2 will use the same dose, patient population, and endpoints as ACUITY, focusing on LCVA change at month three as the primary endpoint.
Secondary endpoints include proportion of 15-letter gainers at three months and LCVA change at six months.
NAION trial (PIONEER-3) will leverage operational synergies with AON trials, using similar centers and data collection methods.
Each indication will have independent statistical powering to maximize success probability.
Privosegtor is a first-in-class neuroprotective peptoid targeting trophic factor pathways.
Market Opportunity and Unmet Need
AON and NAION are orphan indications with over 30,000 annual U.S. cases each and no approved therapies.
U.S. market potential estimated at over $3B for AON and $4B for NAION, with rare disease pricing analogs of $100k–$400k per treatment.
Both indications target concentrated prescriber bases and represent significant unmet needs in neuro-ophthalmology.
Privosegtor could become the first neuroprotective therapy to improve vision outcomes in these conditions.
ACUITY Phase 2 trial showed improvement in visual function and anatomical preservation of the retina.
Rationale for direct NAION registrational trial
Impact of staggered Pioneer trial initiations
Leveraging AON data for MS relapse IND
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Next Oculis Holding earnings date
Q3 202510 Nov, 2025
Next Oculis Holding earnings date
Q3 202510 Nov, 2025
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Frequently asked questions
Oculis Holding AG is a global biopharmaceutical company focused on developing innovative treatments for eye diseases. The company's product pipeline includes several advanced-stage candidates designed to address significant unmet needs in ophthalmology. Notable among these are OCS-01, a topical eye drop for diabetic macular edema and post-cataract surgery inflammation, OCS-02, a topical biologic targeting dry eye disease and uveitis, and OCS-05, aimed at neuro-ophthalmic conditions such as acute optic neuritis and glaucoma. The company is headquartered in Zug, Switzerland, and its shares are listed on the Nasdaq.
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