China's First Scleral Lens Approved for Market: RuiTai Bio Establishes Sino-Australian Joint Venture, Marking a New Era in Ophthalmic Contact Lens Competition

On the afternoon of July 19, 2023, the signing ceremony for the joint venture factory between Guangzhou Raytec Biotechnology Co., Ltd. and Australia's Capricornia Contact Lens Pty Ltd was successfully held in Wenjiang District, Chengdu.

Signing Venue

Guangzhou Raytec Biotechnology Co., Ltd. (hereinafter referred to as Raytec Biotechnology) was established in 2014, with its headquarters located in Guangzhou. It is a high-tech enterprise that focuses on the research and development, transformation, and sales of innovative ophthalmic medical devices. The other party to the agreement, Capricornia Contact Lens Pty Ltd (hereinafter referred to as Capricornia), was founded in 1985 in Brisbane, Australia. For 35 years, it has been dedicated to the research and production of contact lenses and is the leading contact lens brand in Australia and New Zealand.

In March this year, Raytec Biotechnology received favor from Songhe Capital, Zhongda Venture Capital, and Huimei Capital, completing a nearly 100-million-yuan A+ round of financing. In June, the Capricornia scleral lens — Epicon, which Raytec Biotechnology originally imported, was approved for marketing. Epicon belongs to Class III medical devices and is currently the only approved scleral lens in China, mainly used to improve moderate to severe dry eye syndrome and correct irregular astigmatism caused by various reasons. In July, Raytec Biotechnology established a joint venture, Epicon (Chengdu) Medical Technology Co., Ltd., with Capricornia.

Facing the successive major moves by Raytec Biotechnology, the editor of VCBeat walked into the event venue with many questions and had a long conversation with Mr. Lin Yongliang, the founder of Raytec Biotechnology.

Mr. Lin Yongliang tells the story of Raytec Biotechnology starting from a piece of amniotic membrane.

In human embryonic development, the amnion is the basal membrane collagen tissue of the human placenta, which surrounds and protects the embryo. Due to its biological properties, amniotic tissue can be used as a biological repair material for conjunctival surface reconstruction, pterygium excision, surgical wounds, corneal ulcers, leg pressure and venous ulcers, limbal stem cell deficiency, and other indications. In the field of ophthalmology, amnion is used to treat certain eye diseases and injuries. For instance, it is used to treat patients with severe corneal diseases, dry eye syndrome, or other surface disorders, repairing or reconstructing damaged ocular surface tissues, strengthening tissue adhesion, or filling corneal defects.

The wide range of indications for amniotic membrane points to a huge market space. Data from Acumen Research and Consulting shows that the global amniotic membrane market size was $3.1 billion in 2021, and it is expected to reach $10.2 billion by 2030, with a compound annual growth rate of 14.2% from 2022 to 2030.

In the market, for the convenience of transportation, suppliers usually freeze and dry the amniotic membrane to make lyophilized amniotic membrane. However, even under frozen storage conditions, the effective use period of lyophilized amniotic membrane is still limited. Over time, its biological activity may decline, thereby affecting its therapeutic effect.

Raytec Biotechnology uses Cobalt-60 γ-rays to irradiate and sterilize amniotic membranes, and has added its self-developed Freshon preservation solution to ensure the biological activity of the amniotic membranes.After such processing, the biological structure of Raytec Biologics is consistent with fresh amnion, no rehydration is needed, it fits the wound, and the shelf life is up to 3 years.

Active Wet Amnion

Data disclosed by Raytec Biotechnology shows,RayShow, the active wet-state biological sheep membrane independently developed by Raytec Biotechnology, was officially launched in April 2020. It has been listed in 26 provinces, achieving full coverage of 500 tertiary hospitals in China, and has entered listed ophthalmology hospitals such as Aier, Huaxia, and Heshi. This year, its sales revenue is expected to exceed 100 million yuan.

Just as the amnion has witnessed the development of humans from embryo to adult, it has also seen the growth and expansion of Raytec Biotechnology.

In the process of marketing and selling amniotic products, Raytec Biotechnology spotted another emerging market in eye hospitals—the dry eye syndrome market. Epidemiological studies on dry eye syndrome show that there are 344 million patients globally, accounting for 30% of ophthalmology outpatient visits. According to "China Dry Eye Expert Consensus (2020)," the incidence rate of dry eye syndrome in China is approximately 21%-30%, with an estimated minimum of 300 million patients nationwide.

Facing a large patient population and a rapidly growing market space, Raytec Biotechnology aims to enter the dry eye syndrome market as quickly as possible to gain a competitive edge. After conducting comprehensive market research, Raytec Biotechnology set its sights on Capricornia Contact Lens Pty Ltd, the leading brand for scleral lenses in Australia and New Zealand. Capricornia initially developed scleral lenses for the treatment of irregular astigmatism. Scleral lenses are specialized contact lenses, either rigid or soft, designed with a shape and curvature that closely conform to the sclera of the eye, covering the eye's surface. These lenses can be used to correct vision problems such as myopia, hyperopia, and astigmatism.

For patients with dry eye syndrome or other ocular diseases, scleral lenses can serve as a protective barrier to keep the eyes moist and alleviate symptoms. Due to insufficient tear production or abnormal tear quality, patients with dry eye syndrome often experience dryness and discomfort on the surface of their eyes.Scleral lenses can form a stable lubricating chamber on the surface of the eye, allowing tears to flow between the scleral lens and the cornea, providing moisturizing and lubricating effects.

Aipu Corneal Scleral Lens

The scleral lens Aipuco, which has been approved this time, is optimized for the Asian population based on the original product. It directly addresses the clinical needs of patients with irregular astigmatism and moderate to severe dry eye syndrome, filling the gap in the Chinese market for scleral lenses.

Mr. Lin Yongliang talked about Raytec Biotechnology's experience in promoting Epicon in the Hainan Free Trade Zone during an interview: "We found that some patients were reluctant to take off the fitting lens once they wore it during the fitting of scleral lenses. This is because when the scleral lens is applied, it protects the patient’s damaged cornea and forms a layer of tear film, instantly resolving the issue of ocular surface pain and discomfort for the patient."

Raytec Biotechnology will also simultaneously launch "Apricot," the world's only FDA-approved dedicated care device for scleral lenses, providing patients with a complete solution from scleral lens fitting, cleaning, to disinfection.Raytec Biotechnology expects its products on sale this year to achieve approximately 100 million yuan in sales performance.

Raytec Biotechnology and Capricornia jointly establish a joint venture, which is the optimal choice for both parties.

First, the scleral lens EPICOR has been validated in the global market. Don Noack, the founder of Capricornia, is a pioneer in the global contact lens industry and modern orthokeratology, and also the first authoritative expert to propose the computerization of the production process. Capricornia uses advanced computer-controlled lathes to manufacture a full range of custom soft and rigid gas-permeable lenses, capable of producing non-rotationally symmetric geometries.Before its approval, Apocul had already accumulated over 50,000 successful fitting experiences worldwide.

Planning Map of Aipuco Medical Technology Co., Ltd.

Secondly, Raytec Biotechnology has established a sales network covering most of the ophthalmic hospitals in China (including tertiary hospitals) and is expanding its sales network to county-level hospitals. Since the customer base for Raytec Biotechnology's active amniotic membrane products perfectly aligns with that of scleral lens products, during the upcoming promotion of scleral lenses, Mr. Lin Yongliang mentioned that Raytec Biotechnology can reach almost all the hospitals it has previously collaborated with.

Capricornia maintains long-term scientific research and clinical cooperation with Queensland University of Technology, the University of New South Wales, and the State University of New York College of Optometry. Additionally, Capricornia possesses strong R&D capabilities and a substantial user base, excelling in various lens designs and has won numerous lens design awards, covering rigid scleral contact lenses, orthokeratology lenses, as well as rigid and soft corneal contact lenses.

Therefore, Apocura will also leverage Capricornia's advantages in the contact lens product line to successively introduce Capricornia's optometric products, covering defocus soft lenses, toric soft lenses, and multifocal contact lenses. At the same time, it will be equipped with world-leading automated production equipment, striving to build Apocura into a global leading ophthalmic giant.

Raytec Biotechnology mentioned at the signing ceremony,The first collaborative project with Capricornia is to achieve the overseas technology transfer of scleral lenses to China and domestic mass production by the end of 2024. It is expected to reach an annual output value of 600 million yuan in 2025, with an annual tax payment of over 60 million yuan, and will maintain an annual growth rate of more than 30%.

When talking about future plans, Mr. Lin Yongliang mentioned that Raytec Biotechnology hopes to deepen its market presence in the ophthalmology field, optimize the company's products, and provide a full range of solutions for patients with dry eye syndrome. On the basis of ocular surface products, Raytec Biotechnology will also carry out multi-track product layouts, planning to expand into glaucoma and optometry series. It aims to develop and convert innovative ophthalmic medical device products covering three major business segments: ocular surface damage, adolescent myopia prevention and control, and glaucoma treatment, providing multiple supporting products for each track.

"We hope that within three years, Raytec Biotechnology can achieve an IPO to gain capital market support and further grow and develop."