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 –
“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
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) |
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Title: | Update on Therapeutic Suprachoroidal Injection |
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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
Title: | Front-line Local Therapies for Uveitis: From Clinical Trials to Practice |
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Summary: | In his presentation, |
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Ocular Gene Therapy
Title: | Suprachoroidal Delivery for Ocular Gene Therapy: Nonclinical Experiments Evaluating Non-Viral DNA Nanoparticles in Non-Human Primates (NHPs) |
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Summary: | In his presentation, |
Diabetic Macular Edema
Title: | Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Diabetic Macular Edema: A “Real World” Analysis in 28,456 Eyes |
Author: | Thomas A Ciulla, M.D., MBA, Clearside Chief Medical Officer |
Summary: | This retrospective analysis was designed to assess visual acuity (VA) outcomes and anti-VEGF treatment intensity in patients with diabetic macular edema (DME). The analysis of 28,456 eyes was performed in treatment-naïve DME patients from 2013 to 2018, using a database of aggregated de-identified electronic medical records. The study found that although the introduction of anti-VEGF agents has led to notably improved outcomes for patients with DME, there are several practical limitations, including the need for frequent injections and incomplete response in some patients. In clinical practice, DME patients undergo fewer anti-VEGF injections and exhibit worse visual outcomes compared to patients in randomized clinical trials. Consequently, “real world” DME treatment compliance can be poor. This analysis demonstrates a large unmet need for DME therapies that address treatment burden and incomplete response. |
Title: | Analysis of OCT Biomarkers in the Randomized Phase 2 TYBEE Trial of Suprachoroidal CLS-TA Plus Aflibercept Compared with Aflibercept Monotherapy for DME |
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These presentations will be available on Clearside’s website in the Publications section under Programs: https://www.clearsidebio.com/publications.htm.
About CLS-AX (axitinib injectable suspension)
CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer, that achieves pan-VEGF blockade by acting at a different level of the angiogenesis cascade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies and may benefit patients who sub-optimally respond to current anti-VEGF therapies. Suprachoroidal injection of a proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. First, axitinib has intrinsic high potency and can achieve pan-VEGF inhibition through receptor blockade. Second, preclinical results from Clearside and outside investigators showed pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. Third, suprachoroidal administration of axitinib can potentially achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for wet AMD and expects to submit an IND application in mid-2020.
About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)
XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has the exclusive license for the commercialization and development of XIPERE in
About
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding opportunities for expanding Clearside’s internal pipeline, the potential benefits of XIPERE and the SCS injection platform, and the development and potential benefits of CLS-AX, including the timing for the IND submission for CLS-AX. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended
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Source:
Source: Clearside Biomedical, Inc.