Oculis’ Novel Peptidomimetic OCS-05 Shows Promising Results in Phase 2 Trial for Acute Optic Neuritis
OCS-05 Phase 2 Trial Success:
Oculis announced positive results from the Phase 2 ACUITY trial for OCS-05 in treating acute optic neuritis, meeting its primary safety endpoint and achieving statistically significant results on key secondary efficacy endpoints12.
Efficacy Highlights:
OCS-05 demonstrated a 43% improvement in Ganglion Cell-Inner Plexiform Layer (GCIPL) thickness and a 28% improvement in Retinal Nerve Fiber Layer (RNFL) thickness compared to placebo at month 3, with sustained improvements at month 61.
Development Pathways:
The positive results open development pathways for OCS-05 as a potential first-in-class neuroprotective therapy for acute optic neuritis and potentially other neurodegenerative diseases in ophthalmology and neurology15.
Regulatory Progress:
OCS-05 has received IND clearance from the FDA, enabling the initiation of clinical development in the U.S. as part of a global development program1.
Mechanism of Action:
OCS-05 is a novel peptidomimetic small molecule that activates trophic factor pathways such as IGF-1 and BDNF, aiming to protect nerve axons and prevent chronic vision loss in conditions like acute optic neuritis5.
Sources:
1. https://investors.oculis.com/news-releases/news-release-details/oculis-announces-positive-ocs-05-phase-2-acuity-trial-acute
2. https://eyewire.news/news/oculis-announces-positive-phase-2-results-for-ocs-05-in-acute-optic-neuritis-as-a-potential-first-in-class-neuroprotective-therapy