Arctic Vision Obtains China IND Clearance for Presbyopia Treatment

03 September 2021 | Friday | News

Arctic Vision, a China-based clinical-stage ophthalmology company with a leading portfolio of breakthrough technologies, today announced the clearance of the Investigational New Drug (IND) application for Phase III study of ARVN003 (pilocarpine microdose ophthalmic solution) for the treatment of presbyopia by the Center for Drug Evaluation, China National Medical Products Administration (CDE, NMPA). It is the first clinical trial approved in China for presbyopia treatment.
Image Source : Public Domain

Image Source : Public Domain

The main objective of the Phase III clinical study is to evaluate the efficacy and safety of ARVN003 in temporary improvement of near vision in adults with presbyopia. Presbyopia is the non-preventable, age-related hardening of the lens, which causes a gradual loss of the eye's ability to focus on nearby objects. It is estimated to affect nearly 1.8 billion people in the world[1]. Current treatment options are typically device or surgery-based, such as reading glasses, contact lenses, corneal procedures and multifocal intraocular lens implantation.

ARVN003 (known as MicroLine in the US) is a pharmacologic treatment for presbyopia. The product is developed based on Optejet®, a proprietary micro-dosing administration device utilizing MAP™ (Microdose Array Print) technology, and pilocapine, the well-established ophthalmic medicine for temporary improvement of near vision. It has great potential to effectively address the issues of tolerance and bioavailability with the same drugs administered by traditional eye drops.

Dr. Eddy (Hoi Ti) Wu, Founder and CEO of Arctic Vision, said: "We are excited about the Phase III IND approval of ARVN003, a milestone not only for Arctic Vision but also for the domestic research and development in presbyopia treatment, and a reflection of our dedication to advance the development of innovative ocular therapies in China and Asia. With ARVN003, we look forward to providing presbyopia patients a portable solution entirely different from operation or the constant wearing of glasses, to enjoy a quality life with ease and comfort."

Dr. Qing Liu, Chief Medical Officer of Arctic Vision, commented, "Following ARVN002, the IND approved for ARVN003 Phase III study is another milestone for the clinical application of the proprietary MAP™ technology. We will work towards early start of the clinical study and product launch as potentially the first pharmacologic treatment for presbyopia approved in China, providing new option to large populations with presbyopia in China and Asia."

In August 2020, Arctic Vision obtained an exclusive license for the development and commercialization of ARVN003 (MicroLine) and ARVN002 (MicroPine), in Greater China and South Korea from Eyenovia, a U.S.-based clinical-stage biopharma company. In May 2021, Eyenovia announced positive topline results and the reaching of the primary endpoint for its VISION-1 Phase III study of MicroLine, and that preparation of the second Phase III study VISION-2 is currently underway.


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