Clearside Biomedical Positive OASIS and Extension Study Data Presented at The Retina Society 56th Annual Scientific Meeting

- Excellent Safety Profile, Stable Vision, and Reduced Frequency of Injections Observed for up to 6 months –

- ODYSSEY Phase 2b Clinical Trial Enrollment is On Track with Data Expected in Q3 2024 -

ALPHARETTA, Ga., Oct. 16, 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 key data from the Phase 1/2a OASIS clinical trial were presented at The Retina Society 56th Annual Scientific Meeting. The results of the trial demonstrate the key benefits of Clearside’s patented suprachoroidal delivery platform and its lead drug candidate, CLS-AX (axitinib injectable suspension) being developed for the treatment of neovascular age-related macular degeneration (wet AMD or nAMD).

The presentation, entitled, “Safety and Tolerability of CLS-AX via Suprachoroidal Injection in nAMD Patients with Persistent Activity Following Anti-VEGF Therapy” was delivered by David M. Brown, MD, Retina Consultants of Texas. 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. Based on the data from OASIS, CLS-AX is currently being investigated in a Phase 2b clinical trial entitled ODYSSEY.

“We are looking to replicate the excellent safety profile, stable vision, and reduced frequency of injections we observed in OASIS and the Extension Study through 6 months in our ODYSSEY Phase 2b clinical trial that is actively enrolling participants in the U.S.,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “Our trial is enrolling as planned and we expect data from ODYSSEY in the third quarter of 2024. We continue to believe that our SCS Microinjector is a best-in-class delivery method for retinal diseases as it provides a targeted treatment approach with a reliable, in-office, non-surgical, non-implant delivery mechanism.”

Dr. Brown’s presentation summarized the promising data from Clearside’s 3-month Phase 1/2a OASIS clinical trial and Extension Study through 6 months. Axitinib was described as a highly potent, pan-VEGF TKI to treat wet AMD which has shown 10x more potency than other TKS in preclinical studies. The advantages of suprachoroidal delivery directly targeting the site of disease at the back of the eye were featured through multiple preclinical studies comparing equivalent doses of axitinib injected suprachoroidally versus intravitreally.