Benzinga | Sep 21, 2021 07:13AM EDT

Clearside Biomedical Announces Completion Of Dosing In Cohort 2 Of Phase 1/2a Clinical Trial Of CLS-AX In Wet AMD Patients

Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today completion of dosing in Cohort 2 of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD).



OASIS is a U.S.-based, multi-center, open-label, dose-escalation trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. All Cohort 2 patients have received aflibercept at their first visit and a single dose of CLS-AX at their second visit one month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for three months following the administration of CLS-AX.

"We are pleased to have completed our enrollment and dosing of Cohort 2 patients after the promising safety and tolerability results from Cohort 1," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "All patients in Cohort2 have now received both their aflibercept and CLS-AX doses and will be monitored monthly by their physicians for the next three months. We believe that by combining the pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector(r), we may facilitate an effective treatment option for patients suffering from wet AMD. We expect to report initial safety data from Cohort 2 by the end of this year."

About Neovascular Age-Related Macular Degeneration (wet AMD)

Age-related macular degeneration causes a progressive loss of central vision and is the most common cause of legal blindness in individuals over age 55. Wet AMD is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision, and accounts for the majority of vision loss in patients with this disorder. In the U.S., approximately 11 million patients are living with AMD, and about 20% have the wet form. Current treatments require life-long, frequent injections to maintain efficacy. This treatment regimen tends to cause a treatment burden for patients resulting in reduced compliance and under-treatment leading to potentially limited outcomes.