Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial

ZUG, Switzerland, May 7 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced that it has received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) regarding PIONEER-1, the first registrational trial within the PIONEER Program evaluating Privosegtor for the treatment of optic neuritis (ON). This formal FDA agreement confirms the design and planned analysis of the PIONEER-1 study are adequate to address the objectives necessary to support a future NDA submission, subject to a successful trial outcome and FDA review of the complete submission.