Benzinga | Dec 21, 2021 07:08AM EST

Clearside Biomedical Announced Suprachoroidal Injection of CLS-AX 0.1 mg Dose Well-Tolerated in Cohort 2 with No Treatment Related Adverse Events; Supports Advancement to Cohort 3

Clearside Biomedical, Inc.(NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS(r)), announced today positive safety results from OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside's SCS Microinjector(r). OASIS is evaluating CLS-AX for the treatment of neovascular age-related macular degeneration (wet AMD).

Data reported today includes results from Cohort 2 as well as combined data from Cohorts 1 and 2. The primary endpoints were achieved in Cohort 2 (n=5), as the 0.1 mg dose of CLS-AX was well tolerated with no serious adverse events; there were no treatment emergent adverse events related to aflibercept, CLS-AX or the suprachoroidal injection procedure; and there was no dispersion of drug into the vitreous. In addition, there were no adverse events related to intraocular pressure (IOP), inflammation, or vasculitis. The OASIS Safety Monitoring Committee has reviewed the data and approved advancing to Cohort 3 with a dose of 0.5 mg of CLS-AX.

Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer, commented, "Our OASIS trial continues to demonstrate positive safety results as we escalate the dose. Given that this trial represents the first time a tyrosine kinase inhibitor has been injected suprachoroidally in humans, we started OASIS with low dose levels to establish a foundation for safety. We believe the absence of any dose limiting toxicities in the first two cohorts of the OASIS trial, combined with our pre-clinical toxicology data, supports our plan to escalate to the higher CLS-AX dose of 0.5 mg in Cohort 3 rather than the previous 0.3 mg dose. We have initiated patient screening for Cohort 3, with target completion of this cohort planned for mid-year 2022. We look forward to gathering more data on the potential benefits of combining targeted and compartmentalized suprachoroidal delivery with the broad pan-VEGF attributes of axitinib for patients suffering from wet AMD."