Clearside Biomedical Featured in Multiple Data Presentations at the 44th Virtual Annual Macula Society Meeting - Seite 2

Suprachoroidal Space Injection Platform

Title: Multimodal Imaging of Suprachoroidal Injections: A Retina Surgeon’s Perspective

Lead Author: Seenu Hariprasad, MD

Conclusions: Utilizing novel imaging modalities for ocular injections, three important treatment attributes were demonstrated: 1) acute opening of the suprachoroidal space; 2) circumferential, posterior spread of injectate; and 3) compartmentalization of injectate to posterior tissues away from anterior and corneal tissues. These characterizations support suprachoroidal injections to target affected tissue layers in chorioretinal disorders for potential efficacy benefits, while compartmentalizing therapy away from unaffected tissues for potential safety benefits.

Title: Safety of the Suprachoroidal Injection Procedure Utilizing SCS Microinjector across Three Retinal Disorders

Lead Author: Shree Kurup, MD, FACP

Conclusions: In this analysis, safety data from the day of the procedure was compiled from eight clinical trials where suprachoroidal injections were performed across three disease states, including non-infectious uveitis, diabetic macular edema, and retinal vein occlusion. Analysis included a total of 621 patients who received one or more suprachoroidal injections. Importantly, rare but serious adverse events (SAEs) that are known to occur with intraocular injection were assessed, and there were no SAEs involving lens injury, suprachoroidal hemorrhage, or endophthalmitis in any patient receiving one or more suprachoroidal injections. In these eight clinical trials, the safety profile of suprachoroidal injections was comparable to intravitreal injections alone for events occurring during or on the same day as the injection procedure. The results from the retrospective analysis demonstrated the robustness of the suprachoroidal injection regardless of indication.

Current Anti-VEGF Treatment Outcomes, Treatment Burden, and Unmet Need

Title: Anti-VEGF Outcomes in RVO-Related Macular Edema Compared to nAMD and DME: Greater 1-Year Visual Gain but Larger Gap versus Respective Randomized Trials: A Real-World Analysis of 93,756 Patient Eyes

Lead Author: Thomas Ciulla, MD

Conclusions: In this study, real world anti-VEGF treatment outcomes were compared between wet AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO) associated macular edema. In this analysis, 93,756 patient eyes were assessed from de-identified medical records from hundreds of retina specialists across the United States. The assessment found that “real world” RVO patients experienced a modest gain in visual acuity (VA) with anti-VEGF treatment, and that injection frequency plays a large role in this outcome. It was found that an inverse relationship existed between outcomes and baseline VA, with the better baseline VA resulting in an increased risk of VA loss, reflecting a ceiling effect. The analysis showed that “real world” RVO patients experienced greater 1-year VA gain than “real world” wet AMD and DME patients, but exhibited a larger gap compared to respective randomized controlled trials. Current anti-VEGF therapies are associated with significant treatment burden for patients, families, and the health care system; there remains significant unmet need for more effective therapy with durability to address this treatment burden.