Clearside Biomedical Highlights Excellent Safety Profile of CLS-AX and Potential for Extended Duration of Effect in Data Presentation at the American Society of Retina Specialists 41st Annual Scientific Meeting

- Suprachoroidal Injection of CLS-AX Resulted in Favorable Safety Data, Durability and Biologic Effect Over 6 Months -

ALPHARETTA, Ga., July 31, 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 safety and tolerability data from its recent OASIS clinical trial of CLS-AX (axitinib injectable suspension) were presented at the American Society of Retina Specialists (ASRS) 41^st Annual Scientific Meeting. CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor (TKI) axitinib that provides high potency pan-VEGF inhibition delivered via Clearside’s proprietary SCS Microinjector.

The presentation, entitled, “Safety and Tolerability of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients With Persistent Activity After Anti-VEGF Therapy” was delivered by Rahul N. Khurana, MD, FACRS, Northern California Retina Vitreous Associates. Dr. Khurana presented data from Clearside’s OASIS Phase 1/2a clinical trial and Extension Study highlighting the excellent safety profile with no serious adverse events (SAEs), no adverse events (AEs) from inflammation, no vasculitis or vascular occlusion, and no treatment emergent adverse events (TEAEs) related to study treatment.

“The safety profile for new potential treatments in development for wet AMD and other retinal diseases is of paramount importance to physicians and patients. CLS-AX has demonstrated an excellent safety profile to date with no adverse events, and in particular, no inflammation,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “Our treatment approach utilizing our SCS Microinjector is a reliable, in-office, non-surgical, non-implant delivery mechanism to deliver the most potent TKI in development for patients with wet AMD. In addition, we believe that the stable vision and extended duration of effect we observed in OASIS and the Extension Study will carry forward to our ODYSSEY Phase 2b clinical trial currently enrolling participants in the U.S.”

The presentation described the promising results from the 6-Month Extension Study at higher doses in Cohort 3 and Cohort 4. These cohorts showed signs of durability and a 77% - 85% reduction in treatment burden. Additionally, signs of biologic effect with stable mean best corrected visual acuity (BCVA) and stable mean central subfield thickness (CST) to the 6-month timepoint were seen in these cohorts.