CLSD - Clearside Biomedical's Versatile Suprachoroidal Injection Platform Highlighted in Four Ophthalmic Indications in Clinical Data Presentations at AAO 2023 Annual Meeting | Benzinga
ALPHARETTA, Ga., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that multiple oral and poster presentations were delivered at the Annual Meeting of the American Academy of Ophthalmology (AAO) that highlighted encouraging safety and efficacy data from clinical trials of therapies utilizing Clearside's SCS Microinjector® to deliver drug candidates into the suprachoroidal space to treat a variety of retinal diseases.
"The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners," said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "The presentation of OASIS data demonstrates the potential for CLS-AX to be a long-term maintenance therapy for wet AMD by maintaining visual acuity and reducing treatment burden. Two of our partners, REGENXBIO and Aura Biosciences, presented new, positive Phase 2 safety and clinical efficacy data from their respective programs utilizing our SCS Microinjector. Aura also announced that they have received a Special Protocol Assessment from the FDA for the design of their Phase 3 clinical trial in choroidal melanoma that will utilize our SCS Microinjector."
"The data at AAO utilizing our SCS Microinjector evaluated both small molecules and gene therapy spanning four indications: wet AMD, uveitic macular edema, diabetic retinopathy and choroidal melanoma. Taken together, it is clear that we are the leader and the partner of choice in delivering agents into the suprachoroidal space to improve outcomes for patients suffering from a variety of retinal disease," concluded Dr. Lasezkay.
Title: Safety and Tolerability of Suprachoroidal CLS-AX (Axitinib Injectable Suspension) in nAMD Patients in a Phase 1/2a Study, OASIS
Presented by: Rahul N. Khurana, M.D.
Summary: This presentation summarized the promising data from Clearside's 3-month OASIS clinical trial and Extension Study through 6 months. OASIS was an open-label, single dose-escalation Phase 1/2a trial in wet AMD participants to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection via Clearside's SCS Microinjector. CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor (TKI) axitinib that provides high potency pan-VEGF inhibition. In the study, CLS-AX demonstrated an excellent safety profile at all doses and timepoints, with no serious adverse events, no dose limiting toxicities, and no adverse events from inflammation. CLS-AX also exhibited early signs of durability and reduction in treatment burden. CLS-AX is currently being evaluated in a Phase 2b clinical trial, ODYSSEY, for wet AMD.
Partner: REGENXBIO
Title: ALTITUDE: Suprachoroidal Delivery of ABBV-RGX-314 Investigational Gene Therapy for Diabetic Retinopathy
Presented by: Mark R. Barakat M.D. as a Late Breaker Development
Summary: ALTITUDE is a multi-center, open-label, randomized, controlled, dose-escalation trial evaluating the efficacy, safety and tolerability of suprachoroidal delivery of ABBV-RGX-314 using the SCS Microinjector in patients with diabetic retinopathy. The presentation of data showed that ABBV-RGX-314 was well tolerated ...