ALPHARETTA, Ga. - Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company focused on ocular therapies, announced a new commercial partnership through its Asia-Pacific collaborator, Arctic Vision. The agreement with Santen Pharmaceutical Co (OTC:SNPHY)., Ltd. grants Santen rights to commercialize ARVN001, known as XIPERE® in the U.S., for uveitic macular edema (UME) treatment in China, excluding Taiwan, Hong Kong, and Macau.
XIPERE® is a suprachoroidal corticosteroid injection developed by Clearside and marketed in the United States by Bausch + Lomb. The partnership with Santen, a global entity, signifies further endorsement of Clearside's suprachoroidal delivery platform, according to Clearside's CEO, George Lasezkay. He highlighted the platform's adoption in commercial products and clinical programs by various companies.
Arctic Vision has reported progress with ARVN001 in the Asia-Pacific region, including a successful Phase 3 trial in China and ongoing regulatory reviews in Australia and Singapore. The company is also developing the drug for other retinal diseases, such as diabetic macular edema.
Uveitis, an inflammatory ocular condition, affects roughly 350,000 patients in the U.S. and over one million worldwide, with about one-third developing UME. UME is a leading cause of vision impairment in uveitis patients.
Clearside's proprietary suprachoroidal space (SCS®) injection platform and SCS Microinjector® facilitate targeted drug delivery to the back of the eye, potentially improving efficacy and minimizing adverse effects on healthy cells. XIPERE®, approved by the U.S. FDA, is currently available in the U.S.
The news comes with the anticipation of approval and subsequent commercialization of ARVN001 in China, which would mark a significant step in addressing UME in the Asia-Pacific market. The statement is based on a press release issued by Clearside Biomedical, Inc.
In other recent news, Clearside Biomedical has seen significant progress with its lead drug candidate, CLS-AX, now advancing into Phase 3 clinical trials for wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). This comes after promising results from the Phase 2b ODYSSEY trial, which demonstrated a potential reduction in treatment frequency by 84%. The company ended Q1 2024 with a net loss of $11.8 million and operating expenses of $8 million, lower than the estimated $10 million, but maintains financial stability with $35 million in cash. Analysts from H.C. Wainwright, Jones Trading, and Chardan Capital Markets maintain a positive outlook on Clearside Biomedical with price targets ranging from $5 to $6. Clearside Biomedical has also announced the appointment of Tony Gibney as Chair of its Board of Directors, and Glenn C. Yiu, M.D., Ph.D., to its Scientific Advisory Board, highlighting recent developments in the company's leadership.
InvestingPro Insights
Clearside Biomedical's recent partnership announcement with Santen Pharmaceutical (TADAWUL:2070) for the commercialization of ARVN001 in China aligns with the company's strategic focus on expanding its market reach. However, investors should consider some key financial metrics and insights from InvestingPro when evaluating this development.
According to InvestingPro data, Clearside Biomedical has a market capitalization of $83.04 million USD, reflecting its current market valuation. The company's revenue for the last twelve months as of Q2 2024 stands at $7.52 million USD, with a remarkable revenue growth of 365.02% over the same period. This significant growth could be attributed to the increasing adoption of XIPERE® and the potential of its suprachoroidal delivery platform.
However, it's important to note that Clearside is currently not profitable, as indicated by its negative P/E ratio of -2.41 for the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip which states that analysts do not anticipate the company will be profitable this year. The company's operating income margin of -342.48% for the same period further underscores the challenges in achieving profitability.
On a positive note, an InvestingPro Tip highlights that Clearside's liquid assets exceed its short-term obligations, suggesting a relatively stable short-term financial position. This could provide some reassurance to investors as the company continues to pursue growth opportunities like the recent partnership with Santen.
Investors seeking a more comprehensive analysis can access additional insights through InvestingPro, which offers 9 more tips for Clearside Biomedical.
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