Current status and development trend of ophthalmic biomedical materials
Release date: 2016-11-28 Myopia, cataracts, glaucoma, etc. are common eye diseases. Among them, myopia is the most common, with more than 1 billion patients worldwide. Cataract disease is the most dangerous and is one of the major blinding eye diseases, with 17 million people worldwide blinded by cataracts. Biomedical materials for the treatment of ophthalmic diseases include contact lenses, intraocular lenses, artificial corneas, artificial lacrimal tubes, artificial eyeballs, viscoelastic agents, artificial tibia, and long-acting medicine films for the eye. In the past three decades, the ophthalmic medical device market has developed rapidly. According to statistics, in 2010 it was 20 billion US dollars, and it is expected to reach 28 billion US dollars in 2017. International status and market Ophthalmological diseases are medically a major disease, and there are at least dozens of ophthalmic diseases that are currently known. The most common include myopia, hyperopia, presbyopia, astigmatism, cataracts, glaucoma and more. Among the various types of eye diseases, the most common is myopia, and the most dangerous is cataract. At present, the number of patients with global myopia has exceeded 1 billion. About 30% of the population (more than 300 million people) in China suffer from myopia, and the prevalence of myopia in this year has shown a sharp increase in the Chinese youth population, reaching about 80% among the 16 to 22-year-old population. Cataract is one of the world's leading blinding eye diseases. There are currently 17 million people worldwide blinded by cataracts, and this number is increasing by more than 1 million per year. In China, cataract patients have reached about 50 million people. In the past, glaucoma was mainly a disease of the elderly. In recent years, it has begun to show signs of youthfulness. Young and middle-aged people have begun to become a large group of glaucoma patients. In 2012, the number of glaucoma in the world has exceeded 66 million, and the number of glaucoma patients in China has reached 6.5 million. There are currently about 50 million blind patients with corneal disease in the world, and there are 5 million people in China. Foreign corneal donation rate is higher, and China's domestic corneal donation is only about 3,000 cases per year, far from meeting the needs of patients. In the past 30 years, with the development and application of various new biomedical materials and new medical laser equipment, the ophthalmic medical device market has developed rapidly. According to statistics, the global ophthalmic medical device market reached US$17 billion in 2006 and US$20 billion in 2010. It is expected to reach US$28 billion in 2017. The application of biomedical materials in the treatment of ophthalmic diseases covers contact lenses (commonly known as contact lenses), intraocular lenses, artificial corneas, glaucoma implants, vitreous fillers for ophthalmic surgery, viscoelastics, artificial eyeballs, artificial iliac bones, etc. . At present, the largest market is corneal contact lenses for myopia and astigmatism, followed by intraocular lenses for cataract treatment. In 2010, the global contact lens market was 6.1 billion US dollars, the US market was 2.1 billion US dollars, and China was about 300 million US dollars. It is expected that the global corneal contact lens market will increase to US$12 billion in 2017, and the Chinese contact lens market will be close to US$700 million. More than 70% of the global market is currently occupied by products produced by Cibaision, Cooperision, JNJision, and B&L. The current best treatment for cataract treatment is the implantation of an intraocular lens in the removed opaque lens capsule. The global medical device market for cataract intraocular lens surgery was $3 billion in 2010 and is expected to exceed $3.8 billion in 2017. Alcon, Abbott and B&L in the US currently have more than 60% of the global market share. In China, according to the new material “Twelfth Five-Year Planâ€, in 2015, it is estimated that the intraocular lens will need 1.2 million/year. Domestic status, technology and market (1) Domestic status and market About 30% of the population (more than 300 million people) suffer from myopia in China, and the prevalence of myopia has increased sharply in the Chinese youth population in recent years, reaching 80% in the 16 to 22 age group. The number of cataract patients in China has reached 50 million, and 5 million people need surgery, and 400,000 people are added each year. There are 5 million corneal blind patients in China who need corneal transplantation. There are 6.5 million glaucoma patients in China. In 2010, the domestic contact lens market is about 300 million US dollars. It is estimated that the size of China's contact lens market will be close to 700 million US dollars in 2017. In terms of contact lenses, the domestic market is dominated by imported products, including foreign brands Bausch & Lomb, Haichang, Weikang, Johnson & Johnson, Vision, and Ai Jue. In terms of intraocular lenses, the three companies in the United States, Alcon (now Novartis), Eyesight (now Abbott) and Bausch & Lomb, have a market share of more than 80% of the global artificial crystal. At present, at least half of the cataract surgery performed in our country is still a hard intraocular lens that has been eliminated in developed countries. The soft (foldable) intraocular lens is basically imported. There are no manufacturers in China that can completely produce collapsible (soft) artificial crystals. Imported crystals are expensive, generally 2-4 times the selling price of the country of origin. Domestic producers, including Suzhou Liuliu, Zhuhai Iger, Henan Universe, etc., mainly produce hard artificial crystals, although 2007-2008 The State Food and Drug Administration approved the sale of 2-3 domestically produced soft intraocular lenses, but for various reasons, the market share of domestically produced soft intraocular lenses is almost zero. All implants and drains used to treat glaucoma are imported. The domestic market of vitreous filler, silicone oil, inert gas and hyaluronic acid is mainly occupied by American Alcon, Bausch & Lomb and Mellon International. Weihai Saiao New Material Technology Co., Ltd. and Shanghai Huajie, which have just started in China Medical Equipment Co., Ltd. only accounts for less than 10% of the domestic market and is rarely exported. (2) Domestic technology (1) contact lens Wenzhou Medical College developed a high oxygen permeability rigid contact lens (RGP lens). High oxygen permeability rigid contact lens (RGP lens) is the development direction of contact lens in recent years due to its high oxygen permeability, superior optical quality and little effect on the physiological health of the wearer's eye. The market share of RGP lenses in western developed countries is relatively high. The clinical application of RGP lenses in China started late. At present, RGP lenses account for less than 0.1% of the total wearers of contact lenses in China. In recent years, clinical studies have found that RGP lenses can produce superior optical quality compared with frame glasses and soft contact lenses, giving the retina a clear stimulus, inhibiting the growth of the eye axis, and delaying myopia to a certain extent. The development of this is also one of the driving forces for the development of RGP in China in the future. Wenzhou Medical College introduces functional groups on the bulk or surface of the fluorosilicone acrylate polymer material through various physical and chemical methods such as bionic self-assembly technology, low-temperature plasma treatment technology and chemical grafting technology, thereby regulating the charge distribution on the surface of the material. Topological structure and hydrophilicity and hydrophobicity, etc., to reduce the deposition of proteins, lipids and various microorganisms on the surface of the material, improve ion permeability and oxygen permeability, improve the biocompatibility of the lens and the human eye environment, thereby achieving Improve the comfort and corrective effect of the patient's wearing. Wenzhou Medical College has carried out in-depth research in the field of ophthalmic biomaterials research. The research direction mainly focuses on the surface modification of ophthalmic materials such as contact lens and intraocular lens, the development of tissue engineering cornea and ophthalmic drug delivery, and has made important progress. (2) intraocular lens At present, at least half of the cataract surgery performed in our country is still a hard intraocular lens that has been eliminated in developed countries. The soft (foldable) intraocular lens is basically imported. Domestic producers, including Suzhou Liuliu, Zhuhai Eiger, and Henan Universe, mainly produce hard artificial crystals, although the State Food and Drug Administration approved 2-3 domestically produced soft intraocular lenses in 2007-2008. Sales, but for various reasons, the market share of domestically produced soft intraocular lenses is almost zero. Aibo Nuode (Beijing) Medical Technology Co., Ltd. currently has an annual production capacity of 200,000 pieces of soft intraocular lenses. The company's first-generation A1-UV type intraocular lens is a soft foldable intraocular lens based on hydrophobic acrylate material, one-piece and aspherical optical design. It is the most mainstream product on the international market. Products from material synthesis, optical design to processing technology, all have independent intellectual property rights, is the first domestic manufacturer of artificial crystal raw materials. The company's second-generation product is an artificial lens designed according to the Chinese corneal Q value. It is the world's first artificial lens designed and manufactured according to the Chinese human eye structure. Studies have shown that there are significant differences between the Asian population, including the Chinese, and the Western Caucasian human eye structure. Foreign imported products do not take into account the characteristics of the human eye's physiological structure in the design and manufacturing process, nor do they carry out domestic development. Adequate clinical trials, so imported crystals, especially expensive high-end crystals, do not necessarily give Chinese patients the best postoperative visual effects. In cooperation with Beijing Tongren Hospital, Ebonod measured the ocular physiological structure of more than 3,500 patients, including corneal thickness and curvature, aspheric coefficient, pupil diameter, anterior and posterior chamber depth, and crystal capsule size. Based on this model, a high-order aspherical artificial lens conforming to the Chinese eye is designed to improve the visual quality under real clinical conditions. The third-generation products "astigmatism correction type" and "multi-focus" intraocular lens are internationally representative of the latest technology and high value-added refractive products. Currently, R&D and design have been completed, and product self-test and verification are underway. Type inspection phase. At the same time, Heshi Eye Group and Zhuhai Iger are also developing soft intraocular lenses. (3) artificial cornea There are a number of universities and hospitals in China that carry out tissue engineering corneal research, and some companies are promoting the industrialization of tissue engineered corneas. However, there is currently no mature product listed in China. (4) Treatment of glaucoma implant materials, vitreous fillers for ophthalmic surgery, viscoelastics, etc. Sun Yat-sen University Eye Hospital and Guangzhou Yijie Medical Technology Co., Ltd. have developed an injectable in-situ cross-linked hyaluronic acid with viscoelasticity of 1500-2500 mPa, refractive index 1.40±0.3, surface tension vs. pure water 20-40 mN. /m controllable, cross-linking time 2-30 minutes controllable, research shows that its biocompatibility is good, is an ideal vitreous filler, after industrialization will likely replace the current market for ophthalmic silicone oil and gas, with good Industrialization prospects. Glaucoma drains and new viscoelastics are also being studied in several units. (5) New protective spectacle lens viscoelastic body The main manufacturers of domestic polycarbonate lenses are distributed in Fujian, Zhejiang, and Jiangsu. Although the domestic lens manufacturing enterprises have the ability to produce PC lenses, the production capacity is not large compared with the international optical giants. It can be said that industrial production has not been formed. The production capacity is mostly around 200,000-300,000/year, and the process is mostly backward. It does not have its own brand, mainly for OEM processing of foreign importers. In dealing with international importers, it is at a disadvantage, and the profit rate of products is not high. A small number of domestic production companies are also actively developing their own brands, but the brand awareness is low, and it is still unable to compete with international giants. Domestic 5-10 years of development projects (1) New high biocompatible contact lens High oxygen permeability rigid contact lens (RGP lens) is the development direction of contact lens in recent years due to its high oxygen permeability, superior optical quality and little effect on the physiological health of the wearer's eye. In the face of the growing demand for high quality vision correction, the market urgently needs to develop high bioavailable high oxygen permeability contact lens, which improves the surface properties and improves the material while maintaining/improving the oxygen permeability and optical quality of the original material. Its biocompatibility. (two) new intraocular lens Development of a flexible collapsible intraocular lens: Today, phacoemulsification combined with soft collapsible intraocular lens implantation has developed into a mature and popular technology in developed countries, and hard intraocular lenses have been basically eliminated. In the early PMMA material, the hard intraocular lens could not be folded, and an 8-10 mm incision was required during surgery to implant the crystal into the eye. This type of surgery is traumatic to the patient's eyes and has poor visual acuity after surgery. With the invention of the ultrasonic emulsifier, the small incision surgery technique has been rapidly developed, and the intraocular lens made of soft material is placed, the operation is safe and simple, no anesthesia is needed, and the wound does not need to be sutured. At present, foreign artificial crystals are developing in the direction of further high-end. Cataract surgery is undergoing a transition from rehearsal surgery to refractive surgery. Cataract surgery is not only to restore the patient's light, but also to obtain the best optical quality of the intraocular lens after surgery, which can truly meet the daily needs of patients. New artificial crystals have been continuously developed, and multi-focal intraocular lenses, adjustable intraocular lenses, aspherical artificial crystals, astigmatism-corrected intraocular lenses, micro-cut artificial crystals, and anti-blue artificial crystals have emerged. (three) tissue engineering cornea Research on seed cells, scaffold materials and tissue construction. To study the immortalized corneal cells and embryonic stem cell lines to reconstruct the cornea, develop biodegradable degradable materials, and reconstruct corneal with biological characteristics. (4) Treatment of glaucoma implant materials, vitreous fillers, etc. A vitreous filler with good biocompatibility, in vivo metabolism, and convenient surgical operation is developed to replace the currently used inert gas or silicone oil. As one of the active ingredients in the vitreous, hyaluronic acid is an ideal vitreous filler. Development of glaucoma drainage devices, new viscoelastics, and nasal sinus packing materials and artificial hearing bone products. (5) Protective glasses Developed medical polycarbonate spectacle lens (PC) lenses that prevent eye radiation and impact resistance. PC lens is the third generation optical lens after the first generation of glass lens and second generation resin lens. It has many advantages. Its outstanding excellent features include: strong impact resistance, ultra-light, ultra-thin, safe, UV-resistant. , environmental protection and other advantages. PC lenses are 100% UV-resistant and have outstanding advantages in preventing serious eye diseases such as cataracts and ensuring visual health. Source: "China Medical Device Information"
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