Oculis Holding AG (OCS) announced that its neuroprotective candidate Privosegtor was granted breakthrough therapy designation by the FDA for treatment of optic neuritis. In the ACUITY trial, Privosegtor produced substantial vision improvements on the 2.5% ETDRS Low Contrast Letter Acuity chart. Patients receiving Privosegtor 3 mg/kg/day plus IV methylprednisolone gained an average of 18 letters at three months compared with placebo plus IV methylprednisolone.
Mark Kupersmith, Chief Medical Advisor, Neuro-Ophthalmology, said: "The ACUITY trial delivered truly groundbreaking results, demonstrating for the first time in a single study that a drug candidate consistently improves visual function alongside anatomical and biological evidence of neuroprotective benefit."
In pre-market trading on NasdaqGM, Oculis shares are up 8.9 percent to $21.52.
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