China accepts Arctic Vision’s drug application for eye treatment

ALPHARETTA, Ga. - Clearside Biomedical, Inc. (NASDAQ: NASDAQ:CLSD), a biopharmaceutical company focused on ocular therapies, announced that the China National Medical (TASE:BLWV) Products Administration has accepted Arctic Vision’s New Drug Application for ARCATUS®. This drug, designed to treat uveitic macular edema (UME), leverages Clearside’s SCS Microinjector® for delivery to the eye’s suprachoroidal space. The company, currently valued at approximately $80 million, has shown strong financial liquidity with a current ratio of 4.49, according to InvestingPro data.

Arctic Vision’s Phase 3 clinical trial in China, which yielded positive topline results, supports the NDA submission. ARCATUS®, referred to as XIPERE® in the U.S., is the first approved therapy of its kind for UME, with existing approvals in the United States, Australia, and Singapore.

George Lasezkay, President and CEO of Clearside, commented on the development, emphasizing the significance of the Chinese market, which includes several million uveitis patients. He highlighted the innovative delivery platform’s potential to provide extended efficacy with minimal harm to non-diseased eye areas. InvestingPro analysis reveals impressive revenue growth of 248% in the last twelve months, though investors should note the company’s rapid cash burn rate. For detailed insights, including 8 additional ProTips and comprehensive financial metrics, explore InvestingPro’s exclusive research report.

Arctic Vision holds the exclusive license to commercialize and develop XIPERE® in various Asia-Pacific regions. They have also partnered with Santen Pharmaceutical Co (OTC:SNPHY)., Ltd. for the commercialization of ARVN001 in China, excluding Taiwan, Hong Kong, and Macau.

Clearside’s SCS injection platform aims to improve patient outcomes by providing targeted delivery of medications to the back of the eye. XIPERE® is a corticosteroid for the treatment of macular edema associated with uveitis and is currently available in the U.S. through a commercial partner.

Uveitis is an inflammatory eye condition that can lead to vision loss, with approximately one-third of patients developing UME. The global uveitis treatment market is projected to grow significantly by 2032.

This announcement is based on a press release statement from Clearside Biomedical, Inc.

In other recent news, Clearside Biomedical, Inc. has announced significant progress in its ODYSSEY Phase 2b clinical trial for CLS-AX, a treatment for wet age-related macular degeneration (AMD (NASDAQ:AMD)). The trial results indicated that 67% of patients in the CLS-AX group did not require additional treatment for six months, suggesting a durable treatment option. The company is planning a Phase 3 clinical development program based on these findings. Additionally, Clearside showcased its suprachoroidal delivery technology and pipeline programs at recent conferences, highlighting its SCS Microinjector® technology designed for targeted drug delivery to the back of the eye. The ODYSSEY trial met its primary outcomes in visual acuity and safety, showing promising intervention-free rates and a reduction in injection frequency. Clearside also shared real-world data on XIPERE®, a corticosteroid for macular edema associated with uveitis, which is commercially available in the United States. The company’s technology has been used in over 10,000 injections, demonstrating its expertise in ocular therapy delivery. These developments underscore Clearside’s ongoing efforts to advance its ocular therapies and improve patient outcomes.

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