Arctic Vision, a China-based clinical-stage ophthalmology company with a leading portfolio of breakthrough technologies, announced on December 24th the clearance of the Investigational New Drug (IND) for Phase III trial of ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of Uveitic Macular Edema (UME) by China National Medical Products Administration (NMPA). It will be the first clinical trial in China for UME treatment, and also the first one in China to adopt suprachoroidal space (SCS) injection, which is expected to provide a new treatment option for Chinese patients with UME.
This is also the first IND approval for Arctic Vision. "As an emerging Ophthalmology company, we are very excited. It is a major milestone," said Eddy (Hoi Ti) Wu, Ph.D., Founder, and CEO of Arctic Vision. "It took only 9 months for us to get the IND approval after obtaining the exclusive license of TA suprachoroidal injectable suspension, fully demonstrating the 'China speed'. We will work with ophthalmic experts closely to advance this clinical trial. We will strive to get the new drug approval in China as soon as possible to bring the revolutionary solution to patients with UME, to meet urgent clinical needs, and aim to lead the ophthalmology market in China."
The main objective of the current Phase III clinical trial is to evaluate the efficacy and safety of ARVN001 in patients with macular edema secondary to non-infectious uveitis. Results from preclinical studies showed that ARVN001 exhibits good efficacy in multiple animal models, and the unique pharmacokinetic characteristics led to improved efficacy and fewer adverse reactions. The completed US pivotal Phase 3 clinical trial also demonstrated significant improvement in vision for patients UME.
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. Macular edema (ME) is one of the most common structural complications of Uveitis, and also the most frequent cause of both reversible and long-term visual loss among the patients. "The management of UME is one of the major challenges for ophthalmologists in the current clinical practice," said Professor Yang Peizeng, Vice-President of the Chinese Ophthalmological Society, Director of Chongqing Municipal Key Laboratory of Ophthalmology, and Director of the Ophthalmology Department of the First Affiliated Hospital of Chongqing Medical University. "We are excited that Arctic Vision brings the suprachoroidal space injection technology to China so that we could have a new treatment option for UME. I'm looking forward to the regulatory approval of the product in China as soon as possible so that it can help restore vision for millions of patients."
In March 2020, Arctic Vision obtained an exclusive license for the development and commercialization of ARVN001 (TA suprachoroidal injectable suspension developed by Clearside Biomedical, known as XIPERE™ in the United States) in Greater China and South Korea. 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. ARVN001 has been showing to effectively and safely improve the vision and reduce macular edema of patients with UME in the US Pivotal Phase III trial and has the potential to provide new options for other underserved retina-choroid diseases such as Diabetic macular edema (DME) and retinal vein occlusion (RVO).
About Uveitic Macular Edema (UME)
Uveitis is a set of ocular inflammatory conditions and one of the major causes of visual morbidity, it predominantly affects the younger population, and the consequent economic blindness imposes a greater burden on society and healthcare. 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, posterior, or panuveitis.
About Suprachoroidal Space (SCS) Injection Platform
Injection of pharmacotherapy into the suprachoroidal space, between the sclera and choroid, is a novel delivery technique developed with the rationale of providing higher drug concentrations to posterior ocular structures compared with other intraocular and periocular injection procedures. Suprachoroidal (SC) injection with our proprietary SCS Microinjector® could enhance the delivery of therapies for a variety of ophthalmic conditions in which a precise anatomic drug application may yield safety, efficacy, and durability benefits over current therapies.
Targeted: Suprachoroidal injection enables the circumferential dispersion of medicine within the suprachoroidal space to the back of the eye, and quickly reaches a high concentration in the choroid and retina.
Safety: this ocular distribution pattern facilitates compartmentalization within the SCS, minimizing exposure to the anterior chamber and the vitreous, with the potential for safety benefits. It may limit corticosteroid exposure to the anterior chamber, iris, ciliary body, and lens, offering the potential to decrease adverse events (AEs) such as cataracts, intraocular pressure (IOP) elevation, and exacerbation of glaucoma that commonly arise from intravitreal and periocular corticosteroids.
Durability: sustained duration and favorable pharmacokinetics have been observed, with the potential to reduce treatment burden.
The proprietary SCS Microinjector® is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.
About Arctic Vision
Arctic Vision is a China-based clinical-stage specialty ophthalmology company with a leading portfolio of breakthrough technologies. The Company's vision is to address ophthalmology's unmet needs through innovative therapies in China, Asia, and globally. Arctic Vision is established by top-tier life sciences investors and led by an elite team of ophthalmic industry veterans with substantial and compelling China and global experiences in R&D and commercialization of eye care products.