Arvo Biopharma Announces First Patient Dosed in Pivotal Phase 3 Trial of ARVN003 for Presbyopia in China

China's First Presbyopia Drug Clinical Trial Initiated

ShanghaiJuly 4, 2022PR Newswire -- Arctic Vison ("Arctic Vison"), a biotechnology company focused on innovative ophthalmic therapies, announced today that one of the company's core products, ARVN003 -- based on Optejet^®The first patient has been enrolled in the Phase III clinical trial in China for a microdose ophthalmic solution of pilocarpine hydrochloride, developed by Arctic Vison Hong Kong Biotech Limited using a microdosing device, aimed at temporarily improving near vision in patients with presbyopia. This marks the first enrollment of a patient in a Phase III clinical trial for a presbyopia drug in China.

In August 2020, Arctic Vision entered into a collaboration with Eyenovia, a U.S.-based clinical-stage biopharmaceutical company, to obtain the exclusive license for the development and commercialization of ARVN003 (MicroLine) in Greater China and South Korea. In May 2021, Eyenovia announced that the 2% pilocarpine treatment group in MicroLine’s first Phase III clinical trial, VISION-1, successfully achieved the primary efficacy endpoint of a three-line improvement in DCNVA (near vision under best-corrected distance vision) two hours post-dosing.

This approved clinical trial is a randomized, multi-center, double-blind, placebo-controlled Phase III clinical study. Its primary objective is to evaluate the efficacy and safety of using ARVN003 for the temporary improvement of near vision in adult patients with presbyopia. This marks the first presbyopia drug clinical trial approved in China.

With age, the human eye's lens gradually hardens and loses elasticity, and the function of the ciliary muscle progressively declines, leading to a gradual decrease in the eye's accommodative ability. This results in difficulties with near work such as reading, a physiological phenomenon known as presbyopia. Generally speaking, the pre-presbyopia stage refers to ages 35-45, early presbyopia refers to ages 45-52, and late or absolute presbyopia refers to ages above 52. Currently, nearly one-quarter of the global population is affected by presbyopia.^[1]In recent years, with the acceleration of China's aging population, the number of people suffering from presbyopia is increasing year by year. Relevant data shows that in 2021, the population of people with presbyopia in China exceeded 390 million.^[2]。

Current treatment options for presbyopia correction mainly include reading glasses, contact lenses, and surgery. Due to limited treatment options and insufficient scientific awareness of the condition, many people with presbyopia in China do not take timely measures or correct their vision. However, presbyopia not only affects the visual health, quality of work and life, and mental health of middle-aged and elderly individuals but also has the potential to become a factor contributing to family and societal economic burdens.

The principal investigator of this Phase III clinical trial, the academic leader in optometry and vision science in China — Professor Jia Qu, Director of the Eye Optometry Center at Wenzhou Medical University and President of the Eye Optometry Hospital Group, stated: "With the intensification of aging in China and the trend of presbyopia patients becoming younger, there is a significant demand for effective, safe, and convenient treatments for presbyopia. I am very pleased to lead this first clinical study on presbyopia drugs in China, and I look forward to the early approval and market launch of Arctic Vision's ARVN003."

Dr. Qing Liu, Co-founder and Chief Medical Officer of Arctic Vision, stated: "The clinical progress of ARVN003 is highly encouraging for us. Following the completion of the first dosing in an Asian DME patient in the clinical trial of Pulse™ for Diabetic Macular Edema (DME), this marks another significant clinical milestone achieved through our core MAP™ Micro-Matrix Drug Film Platform technology in the field of public eye health. We will continue to advance steadily, striving to make ARVN003 the first approved presbyopia treatment drug in China, providing more diverse options and breakthrough advancements to current treatment solutions, benefiting numerous patients with presbyopia."

About ARVN003

ARVN003 is a product based on Optejet^®ARVN003: A Patented Microdose Formulation of Pilocarpine (Pilocarpine Nitrate) Ophthalmic Solution for "On-Demand" Improvement of Near Vision in Presbyopic Patients. The mechanism of pilocarpine ophthalmic solution for improving near vision through miosis is well-known, acting by creating an extended depth of focus via the pinhole effect. ARVN003 utilizes the patented Optejet® delivery device to provide highly precise microdosing, effectively addressing issues such as tolerability and bioavailability associated with traditional eye drops delivering the same medication.

About the Innovative Drug Delivery System Optejet^®

Optejet for Ophthalmic Treatment^®Microdose drug formulations and delivery platforms use high-precision piezo printing technology to achieve approximately 8μL of drug administration, consistent with the tear film volume of the human eye. The amount of ocular medication delivered using Optejet® is 80% less than that of conventional eye drop administration, which not only avoids overdosing but also reduces the risk of drug or preservative exposure caused by excessive medication. Eyenovia's patented microfluidic jet technology is specifically designed for rapid and gentle ocular surface drug delivery, capable of delivering medication to the ocular surface in about 80 milliseconds, unaffected by the blink reflex. Optejet^®The successful application has been verified in various clinical settings after basic training with Optejet.^®The success rate of drug delivery exceeds 85%, while the success rate of traditional eye drops is only 40%-50%.^[3]In addition, its intelligent electronic devices and mobile e-health technologies can also record and improve patient compliance.

[1] Refractive Surgery Group of Ophthalmology Branch of Chinese Medical Association. Expert consensus on laser corneal refractive surgery for Chinese patients with age-related accommodative insufficiency and refractive errors (2021) [J]. Chinese Journal of Ophthalmology, 2021, 57(9): 651-657. DOI: 10.3760/cma.j.cn112142-20210523-00246.

[2] "Expert Consensus on the Clinical Application of Aier Eye Hospital's Jingxin Lens Surgery"

[3] 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.