Arctic Vision Introduces Breakthrough Ophthalmic Therapies MicroPine and MicroLine for Myopia and Presbyopia with Enhanced Safety and Minimal Side Effects

Over the past month or so, there has been a flurry of news in the field of ophthalmology.

On July 10, 2020, Ocument Therapeutics (HKEX: 1477), an innovative ophthalmic pharmaceutical company in China, listed on the Hong Kong Stock Exchange. With an issue price of HK$14.66, its opening price on the first day reached HK$43, surging by nearly 200%, and its market capitalization peaked at close to HK$25 billion. On July 29, Aier Medical (688050), a leading domestic manufacturer of intraocular lenses, also listed on the STAR Market, with its opening price rising by over 500% and its market capitalization exceeding RMB 20 billion. The strong performance of these two ophthalmic companies in the secondary market not only reflects investor recognition but also highlights high attention and confidence in the future prospects of China’s ophthalmic market.

Meanwhile, the primary market has also shown significant interest in the ophthalmology sector. On July 14, Arctic Vision, an early-stage company focused on innovative ophthalmic therapies, announced the completion of a $32 million Series A financing round.

Today, Arctic Vision announced another significant partnership. On August 11 (U.S. time), Arctic Vision announced a collaboration with U.S.-based Eyenovia, securing exclusive licenses for two of Eyenovia’s flagship innovative ophthalmic therapies in Greater China and South Korea. The two products are MicroPine, indicated for the treatment of progressive myopia, and MicroLine, indicated for the treatment of presbyopia (also known as age-related farsightedness).

In fact, ophthalmic diseases have long been one of the most closely watched medical subsectors abroad. Clinical research in ophthalmology has consistently remained a hot topic internationally. However, in China, although ophthalmology clinics have gradually become systematized, innovative treatment solutions in this field remain a vast untapped frontier awaiting development.

PharmaBoardroom recently named the five Chinese biotech companies most worth watching in the future. The five nominated companies include BeiGene, I-Mab, Alphamab Oncology, Harbour BioMed, and Arctic Vision. Arctic Vision is the only startup among them that is fully focused on ophthalmology and has not yet entered the pre-IPO stage.

Dr. Eddy Wu (Hu Haidi), founder of Arctic Vision, has spent many years working on the research, development, and commercialization of new drugs at multinational pharmaceutical companies. “My career began at Novartis, where I was primarily responsible for the launch of ranibizumab in the Asia-Pacific, Middle East, and African markets. It was there that I forged an enduring connection with ophthalmic therapeutics,” said Dr. Wu.

After accumulating extensive experience at Novartis, Eddy subsequently joined Allergan China. Through interactions with clinicians, he gradually observed that while China has largely caught up with Europe and the United States in terms of innovation across most therapeutic areas, existing ophthalmic technologies in the country still lag behind global standards.

This clinical pain point prompted Eddy to embark on an entrepreneurial journey. He also persuaded his old friends from Allergan, Dr. Liu Qing and Chen Yi, to join the team, with the aim of jointly transforming the current landscape of ophthalmic diagnosis and treatment in China.

Dr. Liu Qing and Dr. Chen Yi have both dedicated many years to the field of ophthalmology. Previously, Dr. Liu Qing served as Head of Ophthalmology Medical Affairs for Allergan China, and as Head of Clinical Development and Medical Affairs for Alcon Greater China, where he led and drove the successful R&D and market launch of numerous ophthalmic pharmaceuticals, medical devices, and over-the-counter (OTC) products. Dr. Chen Yi brings nearly 20 years of experience in ophthalmic product sales and marketing. He previously managed Allergan China’s eye care business, overseeing full profit-and-loss responsibility for more than 10 products across four distinct ophthalmic therapeutic areas: retina, glaucoma, corticosteroids, and artificial tears.

Shortly after the three-person team was established, it attracted the attention of Dingfeng Life Sciences Capital, a subsidiary of Nan Fung Life Sciences Group, and quickly secured an investment intent after brief discussions. With this funding, Arctic Vision rapidly licensed its first project from Clearside Biomedical (Nasdaq: CLSD) in March 2020, obtainingExclusive license rights for the development and commercialization of ARVN001 (marketed as XIPERE® in the United States) in Greater China and South Korea. The commercial rights to XIPERE® in the United States and Canada were acquired by Bausch + Lomb, a globally renowned eye health company, in October 2019, which further underscores the clinical value of this product.

XIPERE® is a patented triamcinolone acetonide suspension formulation designed for suprachoroidal administration, with FDA marketing approval anticipated in 2021. The Phase III clinical trial results for the treatment of uveitic macular edema were published in July 2020 in Ophthalmology, a premier ophthalmology journal. As assessed using the ETDRS visual acuity chart, approximately 46.9% of patients in the experimental group achieved an improvement of more than 15 letters in visual acuity 24 weeks after receiving XIPERE® treatment, compared to only 15.6% in the control group. More importantly, regarding elevated intraocular pressure and cataract formation associated with ocular corticosteroid use, the experimental and control groups showed comparable outcomes, demonstrating a significant improvement in safety.

Arctic Vision currently plans to initiate clinical studies of ARVN001 for uveitic macular edema, with the prospect of expanding the indication to diabetic macular edema in the near future.

After determining the direction, Arctic Vison immediately collaborated with top researchers in the field of ophthalmology worldwide, andEstablished a Scientific Committee Composed of Scholars from China, the United States, and the United KingdomThe Chinese academic expert is Professor Sun Xinghuai, President-Elect of the Ophthalmology Branch of the Chinese Medical Association and Chair of the Department of Ophthalmology and Visual Science at Shanghai Medical College, Fudan University. The American and British experts are respectively Professor Dr. Scott Cousins, Director of the Macular Disease Research Center at the Duke Eye Center, Duke University School of Medicine, and Professor Dr. Harminder Singh Dua, President of the European Association for Vision and Eye Research (EVER) and Head of the Academic Unit of Ophthalmology and Visual Sciences at the University of Nottingham, UK. The participation of these three distinguished academics provides robust assurance of the scientific rigor and professionalism of Arctic Vision in the field of ophthalmology.

A series of achievements further whetted investors’ appetites. On July 14, 2020,Arctic Vison Announces Completion of $32 Million Series A Financing, led by Morningside Venture Capital, with continued additional investment from original incubation investors Nf Life Sciences and Dingfeng BioCapital.

MicroPine, the product from Arctic Vison’s collaboration with Eyenovia, could become the optimal solution for myopia control. To understand why, we must first examine the current predicament facing atropine eye drops.

In recent years, a series of ophthalmic research institutions, represented by the Singapore National Eye Centre, have posited that low-concentration (0.01–0.1%) atropine can inhibit axial elongation associated with myopia, thereby slowing the progression of myopia in adolescents and teenagers. Based on these findings, numerous low-concentration atropine eye drop products have emerged globally; for instance, Similasan and Medison Pharma have both launched related products.

Naturally, this news quickly spread within China. Upon learning about the therapeutic efficacy of atropine, many parents in China rushed to purchase atropine eye drops through import channels. However, what consumers were unaware of is that while low-concentration atropine eye drops are effective in controlling myopia, all medications carry potential risks. Atropine eye drops may also cause numerous side effects; many adolescents who used atropine eye drops with unstable concentrations experienced adverse reactions such as blurred vision, photophobia, facial flushing, and dry mouth. Consequently, ophthalmology experts in China have appeared in media outlets to highlight the potential side effects associated with the use of atropine eye drops and advise against their use without medical prescription.

These safety concerns have directly led to the cautious stance adopted by China’s National Medical Products Administration (NMPA) toward atropine eye drops. Shingye Ophthalmic Pharmaceutical previously submitted an application for the market approval of atropine sulfate eye drops under the Class 3 regulatory pathway, but the NMPA did not grant approval. Shingye’s product was developed as a generic version referencing Medison Pharma’s 0.01% atropine sulfate eye drops; however, following discussions at an expert meeting on the selection of reference listed drugs, the NMPA determined that the safety and efficacy data for Medison Pharma’s product were insufficient. Clearly, the NMPA remains dissatisfied with the currently available atropine eye drops.

The root cause lies in the administration method of eye drops. The average volume of a single drop can reach 40 μl, whereas the capacity of the conjunctival sac is only about 7 μl. Consequently, the actual dosage per application of currently marketed eye drop products significantly exceeds the capacity of the ocular surface. This excessive volume not only hinders patient absorption but may also lead to adverse reactions, both locally in the eye and systemically. To address this issue, merely controlling the dosage is insufficient; it is also essential to ensure uniform coverage of the ocular surface while reducing the administered volume.

In summary, while atropine is indeed effective in controlling myopia progression, the side effects associated with its eyedrop formulation cannot be overlooked. If the drug dosage can be precisely controlled within the ocular volume capacity while ensuring uniform coverage of the ocular surface, it may be possible to avoid the side effects commonly seen with atropine eyedrops.

The issues currently exhibited by atropine eye drops are precisely the focus that Arctic Vison aims to address through this collaboration.

“Eyenovia's Optejet^®"Patented technology that can uniformly coat the surface of the eyeball with a highly precise drug film within 100 milliseconds. We call this technology 'Micro-Matrix Drug Film,'" said Eddy.

The key to MicroPine’s achievement of low-dose, uniform coverage lies in its patented “micro-matrix drug film” technology.

The single-dose administration volume of the microneedle patch film is 75% lower than that of conventional eye drops, significantly reducing the risk of overdose and adverse reactions caused by exposure to the drug or preservatives. The solution penetrates the ocular surface within approximately 80 ms, unaffected by the blink reflex. Studies have confirmed that the successful administration rate of the microneedle patch film exceeds 85%, whereas the success rate for traditional eye drops is only 40%–50%.

Furthermore, its smart electronic devices and mobile e-health technologies can track and enhance patient adherence, which is particularly applicable to the treatment of myopia in children. The product is equipped with a Bluetooth monitoring system that continuously tracks patients’ medication usage and provides relevant medication reminders.

By combining with different drugs, micro-matrix drug films can be used to treat various ophthalmic indications such as myopia, presbyopia, and pupil dilation. The corresponding products for these three indications have already entered or completed Phase III clinical trials in the United States.

The combination of atropine and microarray drug film forms MicroPine, a myopia treatment product. Eyenovia has further optimized the formulation based on the active ingredient atropine, ensuring stable efficacy and reduced side effects. The product received approval from the U.S. FDA in February 2019 to conduct Phase III registrational clinical trials. To date, Optejet^®In the three completed Phase II clinical trials and two Phase III clinical trials, the micromatrix drug film has demonstrated favorable clinical efficacy and safety, as well as advantages over traditional eye drops.

This is why MicroPine, the subject of Arctic Vision’s latest collaboration, has the potential to become the optimal therapeutic solution for myopia.

MicroLine, a presbyopia treatment product, is formed by combining pilocarpine with a micromatrix film. Similar to atropine, pilocarpine eye drop formulations face a range of adverse reactions caused by excessive dosing. These adverse effects have been effectively addressed through the use of micromatrix film technology.

Unlike MicroPine, MicroLine is not intended to control the further progression of presbyopia; instead, it allows older adults to enjoy youthful visual acuity without the need for reading glasses for at least several hours after use.

Commenting on this collaboration, Eddy stated, “In certain regions of Asia, the prevalence of myopia among children has reached as high as 50%, and this figure continues to rise. Meanwhile, a growing number of individuals over the age of 40 are increasingly affected by age-related presbyopia, which currently can only be managed through medical devices or surgical interventions. Therefore, we are fully confident that MicroPine and MicroLine will address patient needs unmet by traditional treatment options. Furthermore, this collaboration plays a significant complementary role in expanding Arctic Vision’s innovative product pipeline. We believe that through this partnership, we will lead the Chinese ophthalmic treatment market toward an innovative future.”

To date, Arctic Vision’s R&D pipeline has primarily consisted of licensed-in assets. However, in selecting projects, the company has leveraged its unique expertise to identify “cutting-edge” products from around the world with the greatest potential to transform current clinical practices in ophthalmology. According to Arctic Vision’s plans, three licensed-in products will complete clinical trials and enter the Chinese market sequentially over the next three to five years. Regarding future development, Eddy stated to VCBeat that licensing is merely a fast-track approach to address urgent clinical needs. Arctic Vision also intends to rapidly establish its own R&D team to achieve domestic production of ophthalmic therapeutic products.

August 11, 2020 (U.S. Time) — Arctic Vision and Eyenovia, Inc. (NASDAQ: EYEN) today jointly announced the signing of an exclusive license agreement to advance the clinical development and commercialization in Greater China and South Korea of Eyenovia’s two flagship innovative ophthalmic therapies: MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia (also known as farsightedness due to aging). Arctic Vision (hereinafter referred to as “Arctic Vision”) is a clinical-stage biotechnology company dedicated to developing and commercializing innovative ophthalmic therapies in China and across Asia. Eyenovia is a clinical-stage ophthalmic biopharmaceutical company developing a pipeline of products based on its proprietary MAP™ (Microdose Array Print) technology platform.

Under the terms of the agreement, Eyenovia is eligible to receive total potential payments of up to $45.75 million, comprising an upfront payment and additional payments tied to various clinical development milestones, including the initiation of regulatory filings and approvals by Arctic Vison in China and South Korea, as well as reimbursements for related research and development expenses.

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