ALPHARETTA, Ga. - Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical firm focused on ocular therapies, recently presented data on its suprachoroidal delivery technology and pipeline programs. The presentations took place at the 17th Asia-Pacific Vitreo-Retina Society Congress from November 22-24, 2024, in Singapore, and at the Ophthalmology Innovation Summit on November 22-23, 2024, in San Diego, California.
During the events, Clearside highlighted the ODYSSEY trial results for its product CLS-AX in treating wet age-related macular degeneration (AMD (NASDAQ:AMD)) and real-world data on XIPERE® for macular edema associated with uveitis. The company also demonstrated its SCS Microinjector® technology, which facilitates targeted drug delivery to the back of the eye.
Chief Medical (TASE:PMCN) Officer Victor Chong, M.D., MBA, emphasized the strong interest from the medical community in the region, particularly noting full attendance at the suprachoroidal injection procedure demonstration sessions. Clearside's technology has been used in over 10,000 injections, showcasing the company's expertise in commercial, clinical, and regulatory aspects of ocular therapy delivery.
The ODYSSEY Phase 2b clinical trial met its primary outcomes in visual acuity and safety, with CLS-AX showing promising intervention-free rates and a reduction in injection frequency. CLS-AX, a suspension of the tyrosine kinase inhibitor axitinib, is designed for suprachoroidal injection and may offer advantages over existing therapies by targeting the angiogenesis cascade differently.
XIPERE®, which is commercially available in the United States, is a corticosteroid for suprachoroidal use and is approved by the U.S. Food and Drug Administration. The product is licensed to Bausch + Lomb in the U.S. and Canada and to Arctic Vision in other regions, including China and Australia.
Clearside Biomedical's SCS injection platform and SCS Microinjector® aim to improve patient outcomes by enabling precise delivery of a range of therapies to the macula, retina, or choroid. The company is planning a Phase 3 program for CLS-AX and continues to develop its pipeline of small molecule product candidates.
This article is based on a press release statement from Clearside Biomedical, Inc.
In other recent news, Clearside Biomedical reported significant progress in its product pipeline, particularly in the treatment of age-related macular degeneration (AMD). The company announced positive results from the ODYSSEY Phase 2b trial for CLS-AX in wet AMD, showing a favorable safety profile and an 84% reduction in treatment frequency. These developments are recent and show promise for Clearside's future in the biopharmaceutical industry.
The company is also advancing collaborations with Arctic Vision and REGENXBIO, both utilizing Clearside's SCS Microinjector technology. Financially, Clearside is in a robust position with cash reserves of approximately $23.6 million, projected to fund operations into the third quarter of 2025.
Clearside plans to start Phase 3 trials for wet AMD in the second half of 2025. Furthermore, research is ongoing for treatments addressing choroidal damage in geographic atrophy (GA), a condition with a market potential of over $20 billion. However, the timeline for IND submission for the GA program is not yet defined.
InvestingPro Insights
Clearside Biomedical's recent presentations and clinical trial results have garnered significant attention in the ophthalmology community. To provide a more comprehensive financial perspective on the company, let's examine some key metrics from InvestingPro.
As of the latest data, Clearside Biomedical has a market capitalization of $81.91 million, reflecting its position as a small-cap biopharmaceutical company. The company's revenue for the last twelve months as of Q3 2024 stood at $7.7 million, with an impressive revenue growth of 248.39% over the same period. This substantial growth aligns with the company's progress in its clinical trials and the commercial availability of XIPERE®.
However, it's important to note that Clearside is currently operating at a loss, with an adjusted operating income of -$24.65 million for the last twelve months. This is not uncommon for biopharmaceutical companies in the development stage, as they often incur significant research and development expenses before achieving profitability.
InvestingPro Tips highlight that Clearside is "quickly burning through cash" and "analysts do not anticipate the company will be profitable this year." These insights are particularly relevant given the company's focus on advancing its pipeline and conducting clinical trials, which require substantial financial resources.
On a positive note, another InvestingPro Tip indicates that "liquid assets exceed short term obligations," suggesting that Clearside maintains a degree of financial stability despite its current unprofitability. This could be crucial as the company progresses towards its planned Phase 3 program for CLS-AX.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Clearside Biomedical, providing a deeper understanding of the company's financial health and market position.
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