On June 20, 2023, Guangzhou Raytec Biotechnology Co., Ltd. announced that the original Australian scleral lens: Epicon A ® Obtained import registration approval from the National Medical Products Administration (NMPA) (National Medical Products Administration [20233160254]) and officially launched in China. Epicon A ® Belonging to the third category of medical devices, it is mainly used to correct irregular astigmatism caused by various reasons, improve the visual quality of patients with various refractive errors, including keratoconus, irregular cornea, corneal degeneration, corneal malnutrition, corneal ulcer, trauma, corneal transplantation, refractive surgery, etc., and improve the visual quality of moderate to severe dry eye. It is the first and currently the only domestically approved scleral lens in China.
Epicon A®,it is the first brand of scleral lenses in Australia and New Zealand, and has accumulated over 50000 successful fitting records worldwide so far. Capkonia Contact Lens Co., Ltd., a manufacturer in Australia, was one of the first manufacturers in the world to develop scleral lenses. For nearly 30 years, they have been focusing on optimizing the design and adaptation of scleral lenses. The approved scleral lens has been optimized and designed for the Asian population. On January 1, 2020, Epicon A® Having settled in Boao, Hainan, more than 300 patients in China have benefited from this product. Due to clinical urgent needs, it became one of the second batch of 11 RWS green channel pilot products of NMPA in December 2020, and was officially approved two and a half years later. Epicon A® The fitting process is simple, the learning curve is short, and the success rate of a single fitting is as high as 71%. Therefore, the compatibility and efficacy have received unanimous praise from doctors and patients.
Epicon A® The scleral lens bridges across the cornea and does not come into contact with the cornea. The lens lands on the sclera, making it very comfortable to wear. The lenses are made of the world's latest and top-notch hard mirror material, Boston XO2 (with a Dk value of 141), which not only has a high oxygen permeability, but also achieves a perfect balance between lens hardness and surface wettability. Epicon A® Adopting a three zone design with independent adjustments, the main road is simplified; Innovative 360 ° independent point-to-point adjustment for all eye surfaces in the entire region; The powerful double loop design and personalized customized lenses meet all wearing needs, truly achieving the goal of covering all eyes.
In response to the difficulties in cleaning and caring for scleral lenses, in addition to the launch of Epicon A® in Australia in addition to scleral lenses, Guangzhou Raytec Company has also launched the world's only specialized care device for scleral lenses - Epjing ™： Patented electrophoretic dissociation technology, certified by FDA510K, uses only physiological saline to instantly sterilize and kill viruses, clean and remove proteins, achieving full coverage of scleral mirror care process in one step.
As the first scleral lens approved in China, Guangzhou Raytec stated that it will launch a nationwide promotion campaign to promote Epicon A® Scleroscope can quickly enter various fitting centers to meet the needs of patients.