Clearside Biomedical Poster Presentation at ARVO 2022 Annual Meeting Demonstrates Versatility of Suprachoroidal Delivery Technology

Clearside Biomedical, Inc. announced that several poster presentations were delivered on Clearside’s proprietary suprachoroidal delivery platform, XIPERE®, and gene therapy delivery utilizing Clearside’s SCS Microinjector® at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting.

“Our data presented at ARVO demonstrated that suprachoroidal delivery via our SCS Microinjector® enabled targeting, compartmentalization, and durability of small molecule suspensions, thereby potentially addressing some of the efficacy, safety, and treatment burden limitations of current retinal therapies,” said Thomas A. Ciulla, MD, MBA, chief medical officer and chief development officer at Clearside Biomedical. “While our US FDA approval of XIPERE validates our suprachoroidal delivery technology, this is just the beginning. We continue to evaluate additional small molecule suspensions to expand our pipeline while demonstrating the flexibility and versatility of our platform to deliver promising treatments for multiple retinal diseases.”

At ARVO, Viral Kansara, PhD, vice president of preclinical development at Clearside Biomedical, presented a poster entitled, “Targeting, Compartmentalization and Durability of Suprachoroidally Injected Small Molecule Suspensions” that summarized the preclinical and clinical evaluation of SCS Microinjector-based suprachoroidal (SC) delivery, and its synergy with small molecule suspensions for a potentially safe, efficacious and durable ocular delivery platform. The studies showed several key findings:

• SC-injected small molecule suspensions, at studied dose levels and duration, were well-tolerated in rabbits;
• Ex-vivo and in-vivo imaging confirmed posterior spread and opening of the SCS immediately after the SC injection;
• SC-injected small molecule suspensions achieved high and durable drug levels in the retina and retina-choroid-sclera;
• SC-injected small molecule suspensions demonstrated targeted and compartmentalized drug levels to the chorioretina, and low to minimal drug exposure in the lens, vitreous humor, and aqueous humor; and
• SC-injected axitinib and triamcinolone acetonide suspensions demonstrated signs of biological activities in preclinical animal models and in the clinic.

Partner Presentations

Several posters were presented at ARVO related to XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use:

"National Physician Survey on Clinical Practice Patterns for the Treatment of Noninfectious Uveitis." Cavet et al.
"Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Effect of Disease Characteristics on Clinical Outcomes." Singer et al.
"Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Integrated Analysis of Two Clinical Trials." Yeh et al.
"Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Outcomes by Anatomic Subtypes in PEACHTREE." Nguyen et al.
"Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Visual and Anatomic Outcomes by Age." Henry et al.

Two presentations were delivered on REGENXBIO asset RGX-314 administered via Clearside’s SCS Microinjector:

“Suprachoroidal Delivery of RGX-314 Gene Therapy for Neovascular AMD: The Phase II AAVIATE™ Study”
“Suprachoroidal Delivery of RGX-314 for Diabetic Retinopathy: The Phase II ALTITUDE™ Study”