(RTTNews) - Clearside Biomedical, Inc. (CLSD), a biopharmaceutical company specializing in eye care, Thursday announced that its Asia-Pacific partner, Arctic Vision, has received acceptance of its New Drug Application or NDA for ARCATUS or XIPERE in the U.S. for regulatory review in China.
The submission marks a significant milestone in the company's global expansion.
ARCATUS is the first and only approved suprachoroidal therapy for treating uveitic macular edema or UME, a leading cause of vision loss.
The NDA submission is supported by positive topline results from Arctic Vision's Phase 3 clinical trial in China, further validating the treatment's potential.
This innovative therapy utilizes Clearside's proprietary SCS Microinjector, which enables targeted delivery of medicine to the back of the eye, improving efficacy and minimizing harm to surrounding healthy tissue.
ARCATUS is already approved in the U.S., Australia, and Singapore. Clearside's President and CEO, George Lasezkay, expressed enthusiasm about Arctic Vision's progress in advancing the product in the Asia-Pacific region.
The Chinese UME market offers significant potential, as it is home to millions of uveitis patients, making this a key development for the company.
Currently, CLSD is trading at $1.04, down by 0.96 percent on the Nasdaq.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
