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Present situation and development trend of ophthalmology of biomedical materials
 
Author:中國銘鉉 企劃部  Release Time:2016-11-29 8:47:52  Number Browse:1257
 

Medical network - on November 28, myopia, cataracts, glaucoma is a common eye disease, etc. The myopia disease, the most common global more than 1 billion patients. The highest cataract disease risk, is one of the main blinding eye disease, there are 17 million people worldwide because of cataract blindness. Eye disease treatment in biomedical materials including corneal contact lens, intraocular lens, artificial cornea, artificial lacrimal duct and artificial eye, viscoelastic agent, artificial bone, eye ophthalmic long-acting, etc. In recent 30 years, ophthalmic medical device market is developing rapidly. According to statistics, in 2010 for $2010, is expected in 2017 will amount to $28 billion.

The international situation and the market

Eye disease in medicine belong to major disease, at present already know at least dozens of eye disease.

The most common include myopia, farsightedness, presbyopia, astigmatism, cataracts, glaucoma, etc. In all kinds of eye disease, the most common is myopia, is the highest risk of cataract. At present, the global prevalence of myopia has more than 1 billion. In China, about 30% of the population of more than three hundred million people suffer from myopia, and this year to myopia incidence showed a trend of rapid growth in the Chinese youth group, at the age of 16 and 22 groups has amounted to about 80%.

Cataract is one of the main blinding eye disease in the world, at present there are 17 million people around the world because of cataract blindness, and this increase to more than 100 / year. In China, the cataract patients has reached about 50 million people.

Glaucoma is primarily a disease in the elderly in the past, began to appear younger in recent years, the young people began to become the huge glaucoma patient groups. The global number of glaucoma has more than 66 million, 2012, 6.5 million patients with glaucoma in China.

Currently about 50 million patients with corneal disease blind in the world, China is 5 million. Foreign cornea donation rates higher, and China's domestic cornea donation was only about 3000 cases, far cannot meet the demand of patients.

In recent three decades, along with all kinds of new type of biomedical material and new medical laser equipment development and application of ophthalmic medical instrument market got rapid development. According to statistics, in 2006 the global ophthalmic medical equipment market has reached $17 billion, $2010 in 20 billion, is expected to reach $2017 in 28 billion.

Biomedical materials in the application of eye disease treatment covers corneal contact lens (commonly known as contact lenses), intraocular lens, artificial cornea to treat glaucoma implant materials, eye surgery with vitreous fillers, viscoelastic body, artificial eye, artificial bone, etc. The market at present is the largest of cornea contact lens to cure myopia and astigmatism, and the second is to cure cataract intraocular lens.

Global corneal contact lens the size of the market in 2010 was $6.1 billion, the U.S. market for $2.1 billion, about $300 million in China. Expects 2017 global corneal contact lens market scale will increase to $12 billion, the Chinese corneal contact lens market scale will be close to $700 million. At present, more than 70% of the global market by American Cibaision, Cooperision, JNJision, and B&L four products.

Currently the best treatment is to cure cataract removal of opacity in the lens implanted intraocular lens. Surgery for cataract intraocular lens of global medical device market size of $2010 in 3 billion, is expected to more than $3.8 billion in 2017. The current us Alcon, Abbott and B&L company owns more than 60% of global market share. According to the new material "twelfth five-year" plan in China, in 2015, is expected to take intraocular intraocular lens 1.2 million/year.

The domestic status quo, technology and market

(a) domestic present situation and the market

In China, about 30% of the population of more than three hundred million people suffer from myopia, and in recent years the incidence of myopia in young people in China showed a trend of rapid growth, at the age of 16 and 22 groups has amounted to about 80%. Cataract patients has reached about 50 million people in China, the need for surgical treatment of 5 million people, and an annual increase of 400000 people. Our country has 5 million corneal blindness patients need for corneal transplantation. Our country of 6.5 million patients with glaucoma. Domestic corneal contact lens in 2010 market size of about $300 million, is expected in 2017 China corneal contact lens market size will be close to $700 million.

In terms of cornea contact lens, the domestic market to imported products dominated, including foreign brands bausch, hydron, weicon, Johnson &johnson, depending on the kang, moxa jue, etc.

In terms of intraocular lens, the United States of alcon (now at novartis), 30 (now at abbott laboratories), and bausch three companies monopoly artificial lens more than 80% of the global market share.

At present our country to carry out the cataract surgery at least half of the use or developed countries already eliminated hard artificial crystal, soft (folding) artificial crystal basically rely on imports. Our country has not yet been fully independent production folding (soft) artificial crystal manufacturers. Import crystal is expensive, typically 2 to 4 times the price of country of origin sales, domestic producers, including suzhou 2007th, zhuhai egger, henan universe, etc., are based on the production hard artificial crystal is given priority to, although the 2007-2008, the state food and drug administration approved the 2-3 domestic sales of soft artificial crystal, but for various reasons, the current market share of domestic soft artificial crystal is almost zero.

The implants used in treatment of glaucoma, the drainage device on all imports. Vitreous fillers of silicone oil, inert gas, hyaluronic acid in the domestic market mainly by the United States alcon company, bausch & lomb company, American international company such as occupation, domestic fledgling weihai "new material technology co., LTD., Shanghai huajie medical equipment co., LTD., in the domestic market also accounted for only less than 10% of the share, rarely export.

(2) domestic technology

(1) the cornea contact lens

Wenzhou medical college development high oxygen into rigid corneal contact lens (contig-oriented lens). High in the air hard corneal contact lens (contig-oriented lens) due to its high in the air, superior optical quality and physiological health effects to the wearer's eye small wait for a characteristic, is the development direction of corneal contact lens in recent years.

Contig-oriented lens of western developed countries the market share is higher, the clinical application of contig-oriented lens of China starts relatively late, the current contig-oriented lenses in domestic accounting for 0.1% of the total corneal contact lens wearer. In recent years the clinical study found that compared with the frame glasses and soft corneal contact lens, contig-oriented lens can produce more superior optical image quality, giving the stimulation of the retina to clear, can inhibit the growth of the eye axis, can to a certain extent, delay the development of the children myopia, this is also in the future a period of time to promote contig-oriented in one of the power of the development of China.

Wenzhou medical college by bionic self-assembly technology, low temperature plasma processing technology and chemical grafting technology and various physical and chemical methods of introducing fluorine silicone acrylate polymer material ontology or surface functional groups, so as to control material on the surface of the charge distribution, topology structure and the feeling of water balance, etc., to reduce the protein, lipid, and various kinds of microorganisms in the material on the surface of the deposit, increase oxygen ion permeability and permeability, improve the biocompatibility of the lens and the human environment, so as to achieve the purpose of improve the effect of patients wearing comfort and correct.

Wenzhou medical college in ophthalmology biomaterials research has been carried out in-depth study and research direction are mainly concentrated in the corneal contact lens, such as eye intraocular lens materials surface modification, the development of tissue engineering cornea and ophthalmic drug delivery, and made important progress.

(2) the intraocular lens

At present our country to carry out the cataract surgery at least half of the use or developed countries already eliminated hard artificial crystal, soft (folding) artificial crystal basically rely on imports. Domestic producers, including suzhou 2007th, zhuhai egger, henan universe, etc., are in production of hard artificial crystal is given priority to, although the 2007-2008, the state food and drug administration approved two to three domestic sales of soft artificial crystal, but for various reasons, the current market share of domestic soft artificial crystal is almost zero.

Aibo noble (Beijing) medical technology co., LTD. Has a capacity of 200000 pieces of soft artificial crystal production conditions. Company the first generation product A1 - UV artificial crystal, is based on the hydrophobicity of acrylic ester material, a chip and aspheric optical design of soft foldable intraocular lens, is now the most mainstream products on the international market sales. Products from material synthesis, optical design to processing technology, have completely independent intellectual property rights, is the first domestic manufacturer of artificial crystal materials independently.

The second generation product is designed according to Chinese corneal Q value of artificial crystal, is the world's first artificial crystal structure design and manufacture according to the human eyes. Studies have shown that Asian people including the Chinese and western caucasians structure exist significant differences of human eyes, imported products in the process of design and manufacturing and did not consider the characteristics of human physiological structure, China did not carry out enough clinical trials at home, so the import crystal, especially expensive high-end crystal, not necessarily the best for Chinese patients with postoperative vision effect.

Aibo noble by cooperating with Beijing tongren hospital, measured the eye of more than 3500 patients physiological structure, including corneal thickness and curvature, aspheric coefficient, the pupil diameter, depth, and the size of the lens bag, etc., before and after China eye model is established, and on this basis, the design conforms to China's eye high order aspheric intraocular lens, can improve the visual quality in real clinical conditions.

Third generation product "astigmatism corrected type" and "jiao" artificial crystal, is the representative phototropism of latest technology and high added value products, currently has completed research and development design, ongoing product test and verification, is about to start type test phase. At the same time the ho group of ophthalmology and zhuhai egger are also developing soft artificial crystal.

(3) artificial cornea

How domestic research on tissue engineering cornea university, hospital, there are also companies are to promote the industrialization of tissue-engineered cornea. But there is no mature domestic product on the market.

(4) to treat glaucoma implanted materials, eye surgery with vitreous fillers, viscoelastic agent, etc

Eye hospital of sun yat-sen university and guangzhou a medical technology co., LTD has developed a kind of injectable in-situ crosslinked hyaluronic acid, viscoelasticity, 1500-2500 mpa and controllable and refractive index of 1.40 0.3 mm, surface tension vs water 20-40 mn/m manageable, controllable crosslinking time 2-30 minutes, studies have shown that its good biological compatibility, is the ideal vitreous fillers, industrialization is likely to replace the current market after eye ophthalmic silicone oil and gas, has a good prospect of industrialization.

Glaucoma drainage device and new types of viscoelastic agent also have several units in research.

(5) new viscoelastic body protection glasses

Domestic distribution of the main producers of polycarbonate lenses in fujian, zhejiang, jiangsu, China although lens manufacturing enterprises have the ability to produce PC lens, but capacity compared with the international giant glasses is not scale, can not form industrialization production, capacity mostly around 20-300000 / year, and the process are relatively backward, not with independent brands, mainly for foreign importers to do OEM processing, and the international trade, importers at a disadvantage, product profitability is not high, a small number of domestic production enterprises are also actively develop their own brands, but the brand awareness is low, cannot compete with international giants.

5-10 years of development projects in China

(a) new high biocompatibility corneal contact lens

High in the air hard corneal contact lens (contig-oriented lens) due to its high in the air, superior optical quality and physiological health effects to the wearer's eye small wait for a characteristic, is the development direction of corneal contact lens in recent years. In the face of growing demand for high quality vision correction, the market is an urgent need to research and development of high biological activity of high oxygen into corneal contact lens, in keep/improve original material under the premise of oxygen permeability and optical quality, enhance the surface properties of materials, to improve its biocompatibility.

(2) the new type of intraocular lens

Development soft foldable intraocular lens: now the cataract ultrasonic emulsification combined with soft foldable intraocular lens implantation surgery in developed countries has developed into maturity and popularity of technology, hard intraocular lens has been basically eliminated. Early PMMA material is a hard intraocular lens can't fold, surgery need to pass a 8-10 mm incision, to crystal implanted inside the eye. This kind of operation on the patient's eye traumatic big, poor eyesight after the operation. With the invention of the ultrasonic emulsification instrument, small incision surgery technology rapid development, placed artificial crystal made of soft material, safe and simple operation, without anesthesia, wound also do not need to suture.

Currently abroad intraocular lens in the direction of the further high-end development. Cataract surgery is by choosing to refractile (refractive surgery. Cataract surgery is not only to make the patients recover light, artificial crystal eyes after surgery to get the best quality of optometry, truly meet the needs of the patients daily life. To constantly develop new type of artificial lens, the multifocal lenses, adjustable artificial crystal, aspheric intraocular lens type, astigmatism corrected artificial crystal, artificial crystal micro incision, the blu-ray artificial crystal, etc.

(3) the tissue engineering cornea

Study on seed cells, scaffold materials, organization building. Research immortalized cornea cells, embryonic stem cell lines, reconstruction, development of biodegradable stuff with good biocompatibility, reconstruction with biological characteristics of the cornea.

(4) to treat glaucoma implant materials, such as vitreous fillers

To develop good biocompatibility, can the body metabolism, and convenience of operation of vitreous fillers to replace the current use of inert gas or silicone oil. As one of the effective components in vitreous, hyaluronic acid is an ideal vitreous fillers.

Develop glaucoma drainage device, and nasal sinuses filling materials and new type of viscoelastic artificial auditory ossicle, etc.

(5) protective glasses

Development can prevent eye radiation and impact resistance (PC) medical polycarbonate lens glasses. PC lens is the first generation of glass lenses, of the third generation after the second generation of the resin lenses, optical lenses, it has many advantages, its prominent features include: fine impact resistance is strong, lightweight, ultra-thin, safety, uv protection, environmental protection, etc. PC lens 100% uv protection, to prevent cataracts and other serious eye diseases, ensure visual health has prominent advantages.

 
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