Arctic Vision Obtains China IND Clearance for Phase III Study of ARVN003, the First in China for Presbyopia Treatment

SHANGHAI,Sept. 3,2021 -- 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.

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 studyVISION-2 is currently underway.

About ARVN003

ARVN003 is a proprietary pilocarpine formulation based on microdosing platform Optejet® for the pharmacologic treatment for presbyopia. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. The administration of pilocarpine uses high-precision microdosing platform Optejet® to provide improvement in near vision while enhancing tolerability and usability.

About Optejet®

Optejet uses high-precision piezo-print technology to deliver approximately 8μL of drug,consistent with the capacity of the tear film of the eye. The volume of ophthalmic solution administered with the Optejet is 80% less than that delivered using conventional eye drops,thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology,MAP™is designed for fast ocular surface delivery,where medication is dispensed as an array of microdroplets to the ocular surface in approximately 80 milliseconds,faster than the ocular blink reflex. Ease of use and successful delivery of medication by Optejet has been demonstrated in more than 95% of the attempts after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers[2]. Additionally,its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.

About Arctic Vision

Arctic Vision is a China-based ophthalmic biotech focusing on breakthrough therapies,with a leading portfolio covering pre-clinical stage to commercial stage products. Our vision is to provide innovative therapies in China,Asia and globally to address unmet clinical needs and benefit ophthalmic patients at large. Arctic Vision is supported by top-tier life sciences investors and led by an elite team of ophthalmic industry veterans with substantial regional and global experiences in R&D and commercialization of ophthalmic products. For more information,please visit https://www.arcticvision.com.

Further Reading

1. Eyenovia Announces Positive Topline Results from VISION-1 Phase 3 Clinical Study of MicroLine for the Treatment of Presbyopia

2. Eyenovia and Arctic Vision announce exclusive collaboration and license agreement to develop and commercialize MicroPine and MicroLine in Greater China and South Korea

3. Eyenovia Announces FDA Acceptance of IND for MicroLine for Presbyopia,clearing Path to Initiate Phase 3 Vision Trial by Year End

Reference

[1]. World report on vision. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.

[2]. Pasquale LR,Lin S,Weinreb RN,et al. Latanoprost with high precision,piezo-print microdose delivery for IOP lowering: clinical results of the PG21 study of 0.4 µg daily microdose. Clin Ophthalmol. 2018 Nov 28; 12:2451-2457.

CONTACT: Communications@arcticvision.com

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