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The ACUITY trial is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate the safety and efficacy of once-daily intravenous OCS-05 (2 mg/kg or 3 mg/kg) for five days in patients with acute optic neuritis who are also receiving steroid treatment.

The test results showed,OCS-05 not only met the primary safety endpoint but also demonstrated neuroprotective benefits in preserving retinal structure and was able to improve visual function in patients with acute optic neuritis.The primary endpoint of the trial was the percentage of patients whose electrocardiogram (ECG) parameters changed from normal to abnormal from baseline to the 4th follow-up visit (Day 15), in order to verify the cardiac safety of the drug. The results showed no difference in the proportion of abnormal ECG parameters between the two treatment groups and the placebo group.

Image Source: 123RF

The secondary efficacy endpoint of the trial was to objectively measure the thickness of two different retinal tissue layers in the affected eyes through optical coherence tomography (OCT) imaging, assessing the potential neuroprotective effects of OCS-05 compared to placebo. The results showed,At the 3rd month,In the average change of ganglion cell-inner plexiform layer (GCIPL) thickness compared to baseline, the OCS-05 (3 mg/kg) + steroid treatment group showed a 43% improvement over the placebo + steroid group (p=0.049), with this improvement lasting until the 6th month (p=0.052).In terms of the average change in retinal nerve fiber layer (RNFL) thickness compared to baseline, the OCS-05 (3 mg/kg) + steroid treatment group showed a 28% improvement at month 3 (p=0.045), reaching 30% at month 6 (p=0.033).

Another secondary efficacy endpoint was assessed by measuring the change in the 2.5% low-contrast visual acuity (LCVA) letter chart to evaluate improvements in patients' visual function. The results showed,The patient improved by approximately 18 letters at Month 3 (p=0.004) and by approximately 15 letters at Month 6 (p=0.012).In terms of safety, no drug-related serious adverse events (SAE) were reported.

OCS-05 is a novel peptidomimetic small molecule candidate drug with the potential to become a "first-in-class" neuroprotective therapy for acute optic neuritis and other neuro-ophthalmic diseases.In animal models of neuroinflammation and neurodegeneration, OCS-05 has demonstrated positive effects in preventing retinal ganglion cell damage and is associated with improved motor function.

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References:

[1] Oculis Announces Positive OCS-05 Phase 2 ACUITY Trial in Acute Optic Neuritis, Met Primary Safety Endpoint and Key Secondary Efficacy Endpoints Opening Development Pathways as a Potential First-in-Class Neuroprotective Therapy. Retrieved January 6, 2025 from https://www.globenewswire.com/news-release/2025/01/06/3004348/0/en/Oculis-Announces-Positive-OCS-05-Phase-2-ACUITY-Trial-in-Acute-Optic-Neuritis-Met-Primary-Safety-Endpoint-and-Key-Secondary-Efficacy-Endpoints-Opening-Development-Pathways-as-a-Pot.html

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