Good news to patients with corneal blindness: MIOK Keratoprosthesis, the World's First Artificial Cornea of 100% Non-biological Materials has been approved for listing in China.
BEIJING, Jan. 19, 2022 /PRNewswire/ — On December 7, 2021, MIOK Keratoprosthesis was approved for listing by NMPA, the Chinese agency for regulating drugs and medical devices. MIOK Keratoprosthesis is the world’s first ever approved artificial cornea that requires no co-implantation of donor corneas, and is of great significance across the 60 million patients with corneal blindness worldwide, as MIOK Keratoprosthesis makes it no longer impossible to restore sight to patients with corneal blindness, and ease the burden on their families.
Corneal transplantation is one of the key means to restore sight to patients with corneal blindness. However, there is a high risk for corneal grafting failures and server postoperative complications usually due to the complex immunologic responses to incompatibility in a transplanted organ. Other artificial corneas requiring co-implantation of donor corneas can not avoid such risks either. So MIOK Keratoprosthesis, an artificial cornea of 100% of non-biological materials and requiring no co-implantation of donor corneas, is an ideal option for treating patients with corneal blindness.
MIOK Keratoprosthesis is mainly made of clear PMMA plastic with excellent optical properties and tissue tolerance, and it is intended to restore sight to patients with corneal blindness by providing a transparent optical pathway through an opacified cornea in the treated eye.
With special design and processing, MIOK Keratoprosthesis delivers excellent performance in terms of transparency, light transmission and durability, in addition to high biocompatibility and ease of use for surgical operations, which make it quick integrated with surrounding tissues. With comparison with conventional corneal transplantation and other artificial corneas, MIOK Keratoprosthesis requires no co-implantation of donor cornea, which addresses the lack of donor corneas worldwide and effectively reduces the risk of severe postoperative complications and immune rejection responses. Furthermore, MIOK Keratoprosthesis is indicated to patients with corneal blindness, in cases where a corneal transplantation has failed or runs a high risk for failure, especially to patients with corneal graft failures, corneal scarring/vascularization, chemical/thermal burns, autoimmune diseases (Stevens-Johnson syndrome, pemphigoid, etc.), symblepharon, and severe dry eyes, etc. As a result, it is an effective treatment to patients with corneal blindness caused by a wide range of corneal injuries.
About Microkpro Medical
Beijing Microkpro Medical Instrument Co., Ltd. (Microkpro Medical), founded in 1997, is a company that is focused on artificial vision and committed to restoring vision to the blind through high-tech means. With a long-term unremitting efforts of its excellent R&D team, Microkpro Medical has launched a proprietary artificial cornea: MIOK Keratoprosthesis, and completed its registration NMPA on December 7, 2021. NMPA is the Chinese agency for regulating drugs and medical devices.
And Microkpro Medical has a GMP compliant facility in Daxing Biological Pharmaceutical Industry Base, Beijing, with an annual production capacity of 100,000 Keratoprosthesis in ISO 7/Class 10,000 cleanrooms.
Reference
- Announcement from National Medical Products Administration(NMPA) of China. https://www.nmpa.gov.cn/directory/web/nmpa/yaowen/ypjgyw/20211207172819157.html (First sentence of the first paragraph, Second sentence)
- Official weibo of the Australian Embassy in China.
https://weibo.com/1918101143/JdrWO1Vwp (First sentence of the first paragraph) - Official website of Massachusetts Eye and Ear Center.
https://masseyeandear.org/medical-professionals/keratoprosthesis (Second paragraph, third sentence) - Technical Review Report from Center for Medical Device valuation f NMPA
https://www.cmde.org.cn/directory/web/WS01/images/yMu5pL3HxKSjqENRWjIwMDA4NzijqS5wZGY=.pdf (Third paragraph, fourth paragraph, third sentence)
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