Oculis AG(US:OCS) Globenewswireยท2025-10-06 08:07Core Insights - Oculis Holding AG has advanced its candidate Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the FDA, marking a significant milestone for the company [2][3][7] - The PIONEER Program will include multiple global trials aimed at supporting registrations for Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [1][3][5] Company Overview - Oculis is a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic diseases with significant unmet medical needs [2][16] - The company is led by an experienced management team and supported by international healthcare investors [16] Product Development - Privosegtor is a novel peptoid small molecule candidate that has the potential to be the first neuroprotective therapy for AON and NAION [3][12] - The PIONEER program will consist of three pivotal trials: PIONEER-1 and PIONEER-2 for AON, and PIONEER-3 for NAION, with the first trial expected to start in Q4 2025 [4][5][8] Clinical Trials - PIONEER-1 and PIONEER-2 will evaluate Privosegtor in patients with AON, measuring low-contrast visual acuity at 3 months as the primary endpoint [4][5] - PIONEER-3 will evaluate Privosegtor after the acute onset of NAION, sharing core design elements with the other two trials [5] Market Potential - AON and NAION are rare neuro-ophthalmic diseases with high unmet medical needs for therapies that can provide neuroprotection and preserve vision [6][15] - The CEO of Oculis highlighted that the PIONEER program positions the company as a leader in ophthalmic neuroprotection drug development, targeting multi-billion-dollar markets [7][12] Financial Position - As of September 30, 2025, Oculis reported approximately $182 million in cash, cash equivalents, and short-term investments, with a cash runway expected into the second half of 2027 [9]