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

  • February 25, 2020
  • Home
  • USA
  • 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 XIPERETM 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 InjectionXIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) for Uveitis
Ocular Gene TherapyDiabetic Macular Edema
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 the United States and Canada (through a license agreement between Clearside and Bausch Health’s affiliate).About Clearside BiomedicalClearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.Cautionary Note Regarding Forward-Looking StatementsAny 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 December 31, 2018, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2019, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, 2019, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.Investor and Media Contacts:Source: Clearside Biomedical, Inc. 
Wall St Business News, Latest and Up-to-date Business Stories from Newsmakers of Tomorrow