Suprachoroidal axitinib achieves safety endpoint in phase 1/2a wet AMD trial
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CLS-AX demonstrated positive results in the phase 1/2a OASIS clinical trial in neovascular age-related macular degeneration, Clearside Biomedical announced in a press release.
CLS-AX (axitinib injectable suspension) met the trial’s primary endpoint by demonstrating a positive safety profile at all doses and time points in 27 participants in four cohorts. There were no reports of serious adverse events, treatment-emergent adverse events, dose-limiting toxicities, or adverse events related to inflammation, vasculitis or vascular occlusion.
The results include 3-month data from the four cohorts as well as interim data from an extension study that follows participants for 6 months after one dose of CLS-AX, according to the release.
In cohorts 3 and 4, CLS-AX showed signs of a biologic effect, with stable mean best corrected visual acuity and central subfield thickness at 3 months. Additionally, 69% of the 16 participants in cohorts 3 and 4 did not receive additional therapy at 3 months.
“We are strongly encouraged by the results ... which highlight the potential use of CLS-AX, a highly potent tyrosine kinase inhibitor combined with targeted [suprachoroidal space] delivery, in serious retinal disease,” Thomas A. Ciulla, MD, MBA, Clearside chief medical officer and chief development officer, said in the release. “The positive safety results seen in all four cohorts, combined with evidence that CLS-AX showed biologic effect in a difficult to treat patient population, supports our belief that CLS-AX has the potential to treat retinal diseases with a repeatable, reliable and validated in-office delivery approach using our SCS microinjector.”
Eight patients remain in the extension study, and the company expects 6-month data in the first quarter of 2023. In addition, a phase 2 clinical trial is expected to begin in the first quarter.
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