Clearside Biomedical Announces Positive Data on CLS-AX OASIS Clinical Trial and Use of SCS Microinjector
Clearside Biomedical announced data from presentations delivered at the Angiogenesis, Exudation, and Degeneration 2023 meeting and The Macula Society 46th Annual Meeting.
“The promising durability data from our OASIS clinical trial continues to garner significant attention as a potential treatment option for patients with wet AMD,” George Lasezkay, PharmD, JD, President and Chief Executive Officer, said in a company news release. “Our trial demonstrated that 67% of extension study participants went at least 6 months without needing additional treatment. Furthermore, detailed safety and tolerability data from OASIS reinforced the excellent safety profile for CLS-AX (axitinib injectable suspension) at all doses and timepoints for those patients with previously persistent, active disease. We were also pleased to see the promising data results from our partners utilizing our proprietary SCS Microinjector to administer gene therapy and oncology agents to treat wet AMD, diabetic retinopathy, and choroidal melanoma.”
Clearside’s OASIS full clinical trial data presentation can be accessed on the company’s Events and Presentations page.
Clearside’s medical meeting presentations can be accessed on the company’s Publications and Presentations page.
Angiogenesis, Exudation, and Degeneration 2023 – Virtual Edition
Presentation Title: Suprachoroidal Therapy for Neovascular AMD
Presented by: Mark R. Barakat, M.D., Director of Retinal Research Institute, Retinal Consultants of Arizona, and Clinical Assistant Professor of Ophthalmology, University of Arizona College of Medicine - Phoenix
Dr. Barakat presented data on two key programs in wet age-related macular degeneration (AMD) utilizing Clearside’s SCS Microinjector for suprachoroidal delivery.
The results from Clearside’s OASIS phase 1/2a clinical trial were featured. In the trial, CLS-AX was well tolerated and demonstrated an excellent safety profile across all timepoints and doses. CLS-AX showed promising durability and biologic effect over 6 months in difficult-to-treat patients who were heavily treatment experienced anti-VEGF sub-responders. The data showed that 67% of participants in the extension study went at least 6 months without needing additional treatment, and 50% of participants went beyond 6 months. Overall, extension study participants experienced a 77% - 85% reduction in treatment burden. Plans for Clearside’s phase 2b ODYSSEY clinical trial were also described in the presentation.
Dr. Barakat also presented data from Clearside’s partner, Regenxbio, from its phase 2 AAVIATE clinical trial utilizing RGX-314, a gene therapy delivered via suprachoroidal injection to treat wet AMD. The presentation summarized results showing that suprachoroidal RGX-314 has been well tolerated in cohorts 1-5 (n=85).
Presentation Title: Suprachoroidal Therapy for Diabetic Retinopathy
Presented by Dr. Peter Campochiaro on behalf of REGENXBIO
The Macula Society 46th Annual Meeting
Presentation Title: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients with Persistent Activity Following Anti-VEGF Therapy (OASIS)
Presented by: Baruch D. Kuppermann, MD, PhD, Roger F. Steinert Professor, Chair of the Department of Ophthalmology, and Director of the Gavin Herbert Eye Institute at the University of California, Irvine. He also holds a joint appointment with the Department of Biomedical Engineering at UC Irvine
Dr. Kuppermann presented a summary of the 6-Month Extension Study results from Clearside’s CLS-AX OASIS phase 1/2a clinical trial in participants with wet AMD. The presentation featured the rationale for utilizing CLS-AX in this indication as the agent utilizes Clearside’s proprietary suspension formulation combined with the high potency and pan-VEGF inhibition of the TKI axitinib delivered via Clearside’s SCS Microinjector. This targeted delivery approach to affected tissues may improve the treatment landscape with potential safety, efficacy, durability, and adoption benefits. The Extension Study results showed that CLS-AX had an excellent safety profile and had promising durability with a meaningful reduction in treatment burden across cohorts of between 77%-85%. The study also showed stable central subfield thickness and stable best corrected visual acuity throughout the treatment period.
Presentation Title: A Phase 2 Trial of Belzupacap Sarotalocan (AU-011): An Investigational Targeted Therapy for Choroidal Melanoma via Suprachoroidal Administration
Presented by Dr. Ivana Kim on behalf of the Belzupacap Sarotalocan Investigator Group
Clearside’s partner Aura Biosciences announced Dr. Kim’s presentation of positive interim phase 2 safety and efficacy data of belzupacap sarotalocan (bel-sar) with 9-10 months of follow up evaluating two key clinical endpoints: tumor control and visual acuity preservation using the suprachoroidal route of administration for the first-line treatment of patients with early-stage choroidal melanoma. The data presented showed an excellent response to the therapy with 89-100% tumor control, and a favorable safety profile to date.
Presentation Title: Suprachoroidal Delivery of RGX-314 for Diabetic Retinopathy: The Phase II ALTITUDE® Study
Presented by Dr. Dennis Marcus on behalf of REGENXBIO