Clearside Biomedical Pipeline Highlighted in Oral Presentations at the Annual Angiogenesis and Macula Society Meetings

– Preclinical data presented on lead development asset, CLS-AX (axitinib injectable suspension) –

– Suprachoroidal injection platform featured in multiple indications including wet AMD, uveitis, diabetic macular edema, and ocular gene therapy –

ALPHARETTA, Ga., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside’s pipeline and proprietary SCS Microinjector targeting the suprachoroidal space were given this month at the 17th Annual Angiogenesis Meeting and 43rd Annual Macula Society Meeting.

“February was an extremely productive month for Clearside as our pipeline continues to gain exposure within the physician community, resulting in multiple oral presentations on our programs,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer. “Importantly, preclinical data was discussed on axitinib for suprachoroidal injection (CLS-AX) supporting the potential for long-acting pan-VEGF inhibition in wet AMD. This positive data provides the rationale to advance this asset that could ultimately lead to improved, long-term, real-world visual outcomes and reduced treatment burden for patients. We expect to submit an Investigational New Drug (IND) application for CLS-AX in mid-2020 and we look forward to initiating Phase 1/2 clinical trial.”

Dr. Ciulla concluded, “Numerous presentations were also given on our clinical trials results for XIPERE^TM and on the broad applicability of our suprachoroidal injection platform. Also featured was a discussion on the potential advantages of suprachoroidal injection of gene therapy. We believe that suprachoroidal injection can be an in-office procedure, with potential safety benefits for patients by avoiding the risks of sub-retinal administration. We are grateful to the numerous retinal specialists who dedicated their time at these medical meetings and support our efforts to potentially offer improved treatment options for their patients.”

CLS-AX (axitinib injectable suspension) & Suprachoroidal Injection

Title:	Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
Author:	Shree K. Kurup, M.D., FACP, Director, Division of Vitreoretinal Diseases, Surgery and Ocular Immunology and Uveitis, University Hospitals
Summary:	Dr. Kurup presented the first public data for Clearside’s lead investigational agent, CLS-AX (axitinib injectable suspension) for suprachoroidal injection. Suprachoroidal axitinib has the potential to address primary needs for neovascular AMD patients, as its durability may reduce treatment burden while maintaining vision. Its pan-VEGF inhibition in wet AMD has the potential to be more efficacious than current focused VEGF inhibition approaches.  Information from Dr. Kurup’s literature review showed there is strong preclinical evidence on the potential efficacy of axitinib as a tyrosine kinase inhibitor (TKI). Specifically: (1) Anti-VEGF A upregulated VEGF-C and VEGF-D, (2) axitinib inhibited neovascularization in the cornea, retina, and choroid, and (3) axitinib had improved biocompatibility with ocular cells relative other TKIs. Suprachoroidal CLS-AX was tested in multiple animal models demonstrating high drug concentration in the retina and choroid-RPE/sclera and lower concentration in the vitreous, and reduction of fluorescein leakage and vessel growth versus control. Across all animal models, suprachoroidal CLS-AX was well tolerated with no signs of toxicity at the intended clinical dose, with sparing of the anterior chamber of the eye and systemic circulation. Overall, suprachoroidal CLS-AX could lead to reduced treatment burden on patients and improved, longer term visual outcomes.
Title:	Update on Therapeutic Suprachoroidal Injection
Author:	Thomas A. Albini, M.D., Bascom Palmer Eye Institute; Professor of Clinical Ophthalmology, University of Miami Miller School of Medicine
Summary:	Dr. Albini’s presentation reviewed the benefits and broad uses of suprachoroidal injection as it relates to Clearside’s pipeline. His discussion focused on the key aspects and uses of this delivery mechanism: 1) small molecule suspension suprachoroidal delivery has shown durability and has been demonstrated with triamcinolone, a tyrosine kinase inhibitor (TKI), and a complement inhibitor; 2) suprachoroidal compartmentalization has potential for safety as demonstrated in the clinical trials with triamcinolone; and 3) the unique ocular distribution of suprachoroidal delivery creates a  potential path forward for other therapies including office-based gene therapy and choroidal diseases such as melanoma. Data from Clearside’s clinical trials and information on the Company’s recent partnerships were also referenced.

XIPERE (triamcinolone acetonide suprachoroidal injectable suspension) for Uveitis