China's NMPA Accepts NDA for ARCATUS for Uveitic Macular Edema
Key Insights
Arctic Vision (search)'s New Drug Application (NDA) for ARCATUS (search) has been accepted for review by China's National Medical Products Administration (NMPA).
ARCATUS (search), known as XIPERE in the U.S., is a suprachoroidal therapy for uveitic macular edema (search) (UME) utilizing Clearside's SCS Microinjector.
The NDA is supported by positive Phase 3 clinical trial results in China, demonstrating significant visual acuity improvement and edema control.
Arctic Vision (search), Clearside Biomedical (search)'s partner in the Asia-Pacific region, has announced that its New Drug Application (NDA) for ARCATUS (search) for the treatment of uveitic macular edema (search) (UME) has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration. This marks a significant step toward bringing the innovative therapy to a large patient population in China.
The NDA submission is supported by positive topline results from Arctic Vision (search)’s Phase 3 UME clinical trial conducted in China. The trial demonstrated statistically significant improvements in visual acuity and edema control in patients treated with ARCATUS (search) compared to the sham group.
ARCATUS: A Novel Suprachoroidal Therapy
ARCATUS (search), known as XIPERE in the U.S., utilizes Clearside Biomedical (search)'s proprietary SCS Microinjector to deliver triamcinolone acetonide directly into the suprachoroidal space (SCS). This targeted delivery approach allows for rapid and adequate dispersion of the medicine to the back of the eye, potentially offering longer-lasting effects and minimizing harm to surrounding healthy tissues.
George Lasezkay, PharmD, JD, President and Chief Executive Officer of Clearside, commented, “Our partner, Arctic Vision (search), continues to make excellent progress in advancing our product in the Asia-Pacific region. The Chinese UME market is large, with several million uveitis patients. As the first SCS injection therapy, our product utilizes an innovative delivery platform that 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.”
Clinical Trial Results
The Phase 3 clinical trial in China met its primary and secondary endpoints, demonstrating significant benefits for patients with UME. Specifically, 38.5% of ARVN001-treated patients gained 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more in vision compared to 9.4% in the sham group (p<0.001). Additionally, ARVN001-treated patients experienced a central subfield thickness (CST) reduction of 204.3 microns versus 1.6 microns in the sham group at week 24 (p<0.001).
The mean best corrected visual acuity (BCVA) gain was 9.6 letters at week 4 and 12.2 letters at week 24. The CST changes achieved over 200 microns reduction at week 4 and maintained the reduction to week 24. Importantly, no ocular serious adverse events (SAEs) or new safety signals were reported.
Uveitic Macular Edema: An Unmet Need
Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss, affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of these patients develop uveitic macular edema (search), a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. Macular edema is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location - anterior, intermediate, posterior or pan. The global uveitis treatment market is projected to grow from approximately $2.3 billion in 2023 to $4.5 billion by 2032.
Global Expansion
ARCATUS (search) has already been approved by the Food and Drug Administration in the United States, Therapeutic Goods Administration in Australia, and the Health Sciences Authority in Singapore. Arctic Vision (search) holds the exclusive license for the commercialization and development of XIPERE (ARCATUS) in Greater China, South Korea, Australia, New Zealand, India, and the ASEAN Countries. They also have a commercial collaboration agreement with Santen Pharmaceutical Co., Ltd. to commercialize ARVN001 for the treatment of UME and certain other ophthalmic indications under development in China, excluding Taiwan, Hong Kong, and Macau.