Arctic Vision Announces First Patient Dosed In Phase III Study Of ARVN001 For Treatment Of Macular Edema Associated With Uveitis (UME)

• First-in-class SCS Microinjection therapy
• First clinical registration study and potentially the first approved drug in China targeting macular edema associated with uveitis
• U.S. FDA approved for treatment of macular edema associated with uveitis

• SHANGHAI, Nov. 22, 2021 /PRNewswire/ -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, announced on Nov. 19 that the first set of patients have been dosed in the Phase III study of ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension, known as XIPERE™ in the U.S.) for the treatment of macular edema associated with uveitis (UME) in China. ARVN001 is a first-in-class investigational therapy directly targeting the suprachoroidal space (SCS^®). In the U.S., the New Drug Application (NDA) for XIPERE™ for UME treatment was approved by the U.S. Food and Drug Administration (FDA) on Oct 25, 2021, and the product is expected to be launched soon. 

  

  The Phase III study in China is a randomized double-blind placebo-controlled Phase III trial intended to evaluate the efficacy and safety of ARVN001 in patients with UME. Notably, this trial is the first clinical registration study targeting the indication of UME in China, and the first clinical application of SCS microinjection in China. The U.S. Phase III pivotal study (PEACHTREE)¹ results have demonstrated good efficacy and safety profile of ARVN001, with significant improvement in vision, prominent and lasting reduction of edema, and lower or comparable AE rates of IOP raising and cataract for patients in the experiment treated with ARVN001 for 24 weeks.

  The leading principal investigator of the Phase III study of ARVN001 is Professor Peizeng Yang, an uveitis expert in China. He is also the Head of Ophthalmology at the First Affiliated Hospital of Chongqing Medical University, Director of the Chongqing Key Laboratory of Ophthalmology, and Vice-Chairman of the Chinese Ophthalmological Society. Professor Yang remarked, "The current leading treatment options for UME is local administration of corticosteroid, but it often causes high rates of adverse events, such as cataract, intraocular pressure elevation and glaucoma. Arctic Vision's ARVN001 provides a targeted way of drug delivery through the suprachoroidal space, limiting the exposure to anterior segment, which potentially prolongs pharmacokinetics and decreases adverse events. We are happy to advance the Phase III clinical study of ARVN001, and looking forward to bringing this new treatment option for UME patients in the future."

  Dr. Qing Liu, Chief Medical Officer of Arctic Vision, noted, "As a China-based biotech company in the ophthalmology sector, we are proud to be able to complete the dosing of our first patient in the ARVN001 Phase III trial. No therapy has been approved in China for UME treatment. With the validated efficacy and safety of SCS microinjection, as well as its operational convenience, we remain very confident in advancing the study to address the unmet needs for UME patients, and broadening the application of SCS microinjection in treatment for more ocular fundus diseases. We are here to provide more solutions for ophthalmic patients and the industry meaningfully."

  About Macular Edema Associated with Uveitis (UME)
  Uveitis is a set of ocular inflammatory conditions and one of the major causes of visual morbidity. Macular edema (ME) is a common complication in patients with uveitis, which is characterized by a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. UME is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location - anterior, intermediate or posterior - or panuveitis. It is estimated that there are 3-5 million patients suffering from uveitis in China, representing one of the leading causes of visual impairment among the working-age population. ARVN001 is the world's first approved treatment for macular edema associated with uveitis.

  About ARVN001
  ARVN001 is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space. It has been approved in the U.S. for the treatment of macular edema associated with uveitis (UME), and is now being investigated for diabetic macular edema (DME) and other ocular fundus diseases. The patented SCS Microinjector® technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection 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.

  In March 2020, Arctic Vision acquired the exclusive license for the development and commercialization of XIPERE from U.S.-based ophthalmology player Clearside Medical, Inc. (NASDAQ: CLSD) in Greater China and South Korea, later expanding the license territory to include ASEAN countries and India, and subsequently Australia and New Zealand, in August and September 2021 respectively. ARVN001 is Arctic Vision's project code for XIPERE.

  In September 2021, CFDA has approved the second indication of ARVN001 for the treatment of diabetic macular edema (DME) to proceed to Phase I study. The Company plans to start the clinical trial in China soon.