OCS-05 meets safety, efficacy endpoints in acute optic neuritis trial

Key takeaways:

• The phase 2 ACUITY trial evaluated OCS-05 at 2 mg/kg/day and 3 mg/kg/day.
• The trial met safety and efficacy endpoints.

OCS-05 met safety and efficacy endpoints in the treatment of acute optic neuritis in a phase 2 trial, according to a press release from Oculis.

“While the high-dose steroids used today can shorten the acute inflammatory process, there remains an unmet medical need for therapies that preserve neurons from dying and therefore preserve vision,” Riad Sherif, MD, CEO of Oculis, told Healio. “The ACUITY trial’s positive results highlight a neuroprotective structural and anatomical benefit from OCS-05, protecting retinal ganglion cells and the axons, and its ability to improve visual function in patients suffering from acute optic neuritis.”

In the randomized, double-masked, placebo-controlled, multicenter ACUITY trial, 33 patients with recent onset of unilateral acute optic neuritis with a demyelinating origin received OCS-05 2 mg/kg/day, OCS-05 3 mg/kg/day or placebo. Patients received a once-daily intravenous infusion for 5 days as well as steroids.

Riad Sherif

The trial met its primary safety endpoint, which was evaluated through electrocardiogram (ECG) parameters. No difference in the percentage of patients with abnormal ECG parameters was found between the two treatment arms. Two patients in each OCS-05 arm and one patient in the placebo arm experienced a change from normal to abnormal in any ECG measure by the fourth visit at day 15; the events were mild and transient in the treatment arms and were not considered clinically significant.

Secondary efficacy endpoints were also met, including a 43% improvement in ganglion cell-inner plexiform layer thickness at month 3 in the 3 mg/kg/day arm (P = .049), which was maintained through month 6. There was also a 28% improvement in retinal nerve fiber layer thickness at month 3 in the 3 mg/kg/day arm (P = .045), which reached 30% improvement at month 6 (P = .033). In addition, OCS-05 3 mg/kg/day yielded an improvement of approximately 18 letters at month 3 (P = .004) and approximately 15 letters at month 6 (P = .012).

There were no drug-related serious adverse events or adverse events leading to drug withdrawal or study discontinuation, according to the release.

“Restoring vision to the extent observed in this trial will represent an important benefit for a patient’s daily life,” Sherif told Healio.

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