Clearside Biomedical Announces Data Presentations at the AAO 2020
Clearside Biomedical announced that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting.
Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables, according to Clearside. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies.
“Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS) injection platform during 2020,” Thomas A. Ciulla, MD, MBA, Chief Medical Officer and Chief Development Officer, said in a company news release. “In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) phase 1/2a clinical trial, and our integrin inhibitor preclinical studies.”
Dr. Ciulla continued, “In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, Regenxbio, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector to deliver their assets into the suprachoroidal space.”
Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
Authors: Robert Bhisitkul; Viral Kansara; Thomas Ciulla
Conclusions:
CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The FDA has accepted Clearside’s investigational new drug application and a phase 1/2a clinical trial in wet age-related macular degeneration (AMD) is expected to initiate by the end of 2020.
Title: Systemic Therapy and Efficacy of CLS-TA:Results from the Phase 3 PEACHTREE Clinical Trial
Authors: Quan Nguyen; Thomas Ciulla
Conclusions:
These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline.