Clearside Biomedical Announces Multiple Poster Presentations at ARVO
Clearside Biomedical announced that multiple clinical poster presentations related to its suprachoroidal injection platform and programs were delivered at the Association for Research in Vision and Ophthalmology 2021 Virtual Meeting which took place May 1-7, 2021.
“The posters delivered at ARVO are increasingly important as we advance our CLS-AX clinical program and our New Drug Application for Xipere which is under review by the U.S. Food and Drug Administration,” Thomas A. Ciulla, MD, MBA, Chief Medical Officer and Chief Development Officer, said in a company news release. “The analyses demonstrate the utility of our proprietary suprachoroidal space (SCS) delivery platform to administer small molecules and gene therapy. The data also continues to validate suprachoroidal delivery as an office-based, repeatable form of administration for therapies for multiple retinal disorders.”
Suprachoroidal Space Delivery Platform
Title: Suprachoroidal injections across species via multimodal imaging
Lead Author: Allen Ho
Conclusions: This project compared suprachoroidal and intravitreal injections using diagnostic imaging and documented three important treatment attributes of suprachoroidal delivery: 1) acute opening of the suprachoroidal space; 2) circumferential, posterior spread of injectate in the suprachoroidal space; and 3) compartmentalization of injectate to posterior tissues away from anterior and corneal tissues. In contrast to intravitreal delivery, suprachoroidal drug delivery targets chorioretinal tissue layers, supporting the potential for more precise delivery to potentially enhance safety and efficacy.
Title: Safety of suprachoroidal injection procedure utilizing a microinjector across three retinal disorders
Lead Author: Sumit Sharma
Conclusions: In this analysis, safety data from the day of the procedure was compiled from 626 patients in eight clinical trials where suprachoroidal injections were performed across three disease states, including non-infectious uveitis, diabetic macular edema, and retinal vein occlusion. Overall, across the eight clinical trials, the safety profile of suprachoroidal injections (SCI), either as monotherapy or in conjunction with intravitreal anti-VEGF injections, is broadly comparable to intravitreal anti-VEGF injections alone.
Title: Ophthalmic Procedure Training During COVID-19: Virtual and In-Person Training of the Suprachoroidal Injection Procedure
Lead Author: Nathan Fisher
Conclusions: An analysis was conducted to evaluate virtual and in-person training modalities in educating retinal specialists and other ophthalmology professionals on performing a suprachoroidal injection with the SCS Microinjector. Significant travel and site visitation restrictions associated with the COVID-19 pandemic required alternative virtual methodologies be developed to continue training when traditionally utilized in-person wet lab instruction was not permitted. Importantly, physicians who completed virtual or in-person training felt highly confident in their ability to perform the procedure in patients in the future.
Title: Post-Hoc Analysis of Suprachoroidal Injection Experience for Non-Infectious Uveitis
Lead Author: Milan Shah
Conclusions: This study analyzed procedural characteristics of SCIs using the SCS Microinjector from data in two uveitis trials. Both the user survey and the correlation analysis demonstrated that SCIs are well accepted by physician-investigators, and the two needle lengths accommodate a wide range of anatomic and demographic variables. The analysis also concluded that SCIs with the SCS Microinjector have the potential to reliably and repeatably deliver drugs for chorioretinal diseases in an in-office setting.
Treatment burden and unmet needs with current anti-VEGF-A therapies
Title: Longer term visual acuity outcomes and anti-VEGF therapy intensity in neovascular AMD, diabetic macular edema and retina vein occlusion – related macular edema: a real world analysis of 130,247 patient eyes
Lead Author: Thomas Ciulla, MD
Conclusions: In this study, 130,247 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, DME and AMD patients show worse 3- and 5-year anti-VEGF outcomes, compared to 1-year outcomes, that injection frequency plays a large role in visual acuity outcomes, and that AMD patients treated with fewer than 40 injections within a five-year timeframe lost visual acuity. The study highlights the significant unmet need for more effective and durable therapies to address treatment burden.
Gene Therapy
Title: Suprachoroidally delivered non-viral DNA nanoparticles produce hMyo7A Protein in RPE-choroid in rabbits
Lead Author: Viral Kansara
Conclusions: Functional deficiency of Myosin 7A protein is implicated in the pathogenesis of Usher syndrome, an inherited retinal disease and a form of retinitis pigmentosa. However, adeno-associated viral vectors (AAV) cannot accommodate large genes such as Myo7A, limiting investigational gene therapy for Usher syndrome. The study showed that suprachoroidally delivered DNA nanoparticles containing transgene encoding human Myo7A produced efficient and durable levels of Myosin 7A in RPE-choroid. The data warrant further studies in other species and demonstrated that suprachoroidal delivery has potential as an office-based, repeatable therapy for large-gene disorders.
CLS-TA (XIPERE)
Title: Uveitic macular edema: OCT anatomic and temporal biomarkers
Lead Author: Debra Goldstein
Conclusions: There is limited information on longitudinal structure-functional correlations in uveitic macular edema, the intended indication for CLS-TA. In a post hoc analysis of 198 eyes with uveitic macular edema, this study demonstrated clinically relevant and prognostic relationships between best corrected visual acuity and optical coherence tomography (OCT)-assessed features of macular edema. Importantly, this analysis showed that improvement in macular edema may precede improvement in visual acuity, among patients treated with CLS-TA.