Clearside Biomedical, Inc. (Nasdaq: CLSD) showcased its suprachoroidal delivery technology and pipeline programs at several medical meetings across Asia, Europe, and the United States. The presentations highlighted the company's progress in revolutionizing therapies for the back of the eye through the suprachoroidal space (SCS®).
APVRS Congress Highlights
Clearside's activities at the 17th Asia-Pacific Vitreo-Retina Society (APVRS) Congress in Singapore from November 22-24, 2024, were a focal point. Victor Chong, M.D., MBA, Chief Medical Officer and EVP, Head of Research and Development at Clearside Biomedical, noted the significant impact made at the APVRS Congress with presentations featuring topline ODYSSEY results, XIPERE® real-world data, and posters on the suprachoroidal delivery platform.
Oral presentations included topline results from the ODYSSEY trial and real-world use of suprachoroidal triamcinolone, analyzed via an Iris database. Poster presentations covered biomechanics considerations in suprachoroidal drug delivery, targeting and durability of suprachoroidally injected small molecule suspensions, suprachoroidal delivery of small molecules and gene therapies, and expert guidance on suprachoroidal space injection technique.
SCS Microinjector® Demonstrations
Clearside hosted three separate suprachoroidal space (SCS®) injection procedure demonstration sessions featuring the SCS Microinjector®. These sessions allowed attendees to familiarize themselves with the technology through hands-on testing and education on the novel delivery approach. According to Dr. Chong, each session reached maximum attendance capacity, reflecting the growing interest in Clearside's delivery approach.
OIS and FLORetina Presentations
In addition to APVRS, Clearside's suprachoroidal space (SCS®) injection treatment approach was featured at the Ophthalmology Innovation Summit (OIS) in San Diego, CA. Rafael Andino, Senior Vice President, Engineering & Manufacturing, presented on suprachoroidal drug delivery. Further discussion of Clearside's progress and positive ODYSSEY results is planned for the FLORetina 12th International Congress on OCT and OCT Angiography in Florence, Italy, where Christopher Or, MD, from Stanford University, will present on suprachoroidal axitinib for neovascular AMD.
ODYSSEY Trial Results
The ODYSSEY trial was a Phase 2b clinical trial involving 60 participants with wet AMD previously treated with intravitreal anti-VEGF therapy. Participants were randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization. CLS-AX was administered via suprachoroidal injection using Clearside’s SCS Microinjector, while aflibercept was administered via intravitreal injection. The trial achieved its objectives, including primary outcomes in mean change from baseline in best corrected visual acuity and safety and tolerability of CLS-AX, and secondary outcomes in visual function and ocular anatomy. CLS-AX demonstrated compelling intervention-free rates, with 100% of CLS-AX participants not requiring any additional treatment up to 3 months, 90% up to 4 months, 81% up to 5 months, and 67% up to 6 months after the initial CLS-AX dose. The injection frequency was reduced by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening.
About CLS-AX
CLS-AX (axitinib injectable suspension) is being developed by Clearside as a longer-acting therapy for retinal diseases. Axitinib, a tyrosine kinase inhibitor (TKI), achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may offer efficacy advantages over existing retinal therapies and may benefit patients who sub-optimally respond to current anti-VEGF therapies. Suprachoroidal injection of axitinib has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials, with a positive safety profile.
