Based on positive preclinical data and results of a phase I safety and PK study in healthy volunteers, a phase 2a study (the ACUITY study) was initiated and is currently enrolling patients.
ACUITY is a two-arm, randomized, double-blind, placebo-controlled, monocentric study to evaluate the safety and tolerability of ACT-01 compared to placebo in patients with acute optic neuritis. In addition to safety, secondary outcome measures will include optic nerve anatomical measures, as well as visual function measures. The study is ongoing at the La Pitié-Salpêtrière hospital in Paris within the neurology-ophthalmology network of the Public University Hospital Group in Paris (APHP).
Accure has granted Oculis an exclusive global licensing agreement to develop and commercialize ACT-01.
“ACT-01 originated at IDIBAPS/CSIC.”