About Presbia PLC

Presbia PLC operates as an ophthalmic device company. The company has developed and is in the process of obtaining the U.S. Food and Drug Administration (FDA) approval for a proprietary optical lens implant for treating presbyopia, the age-related loss of the ability to focus on near objects. The company’s lens, which it refer to as its microlens, is a miniature lens designed to be surgically implanted in a patient’s eye to improve that patient’s ability to see objects at close distances. The company’s strategy is to continue to commercialize its microlens in certain strategic countries where the company has marketing approval and to obtain FDA approval for its microlens in the United States. The commercialization of the company’s microlens depends on a prospective patient’s ability to cover the costs of the company’s microlens and the implantation procedure. The company’s microlens procedure is performed using a 150 kilohertz or greater frequency femtosecond laser, which is a laser that is used in certain LASIK surgeries, cataract surgeries and cornea replacement surgeries. In commercializing its solution, it intends to target those markets with a well-established presence of ophthalmic clinics equipped with femtosecond lasers. The company, through its European Union Conformite Europeene mark, is authorized to market its microlens throughout the European Economic Area (all European Union member states plus Iceland, Liechtenstein and Norway), or EEA, and, through mutual recognition agreements, in Switzerland. The company markets its microlens in certain strategic EEA countries, as well as certain strategic countries outside of the EEA in which it possesses marketing approval, such as South Korea. Through March 2019, the company has shipped approximately 2,340 of its microlenses to commercial partners outside of the United States, of which ophthalmic surgeons have implanted approximately 1,350. The company is seeking marketing approval in the United States. Sales and Marketing The company intends to utilize a direct selling structure unless a country requires it to sell through a distributor, agent or it determines that a distributor/agent would offer it a more effective path to commercialization. Research and Development For the year ended December 31, 2018, the company’s research and development expenses were $3.5 million. Patents The company owns six issued U.S. patents, and four pending U.S. patent applications, all of which it considers material to its business. Three of its existing patents relate to its microlens inserter and corresponding methods of use; these patents expire in 2030 or 2031. Two additional patents relate to the method and apparatus to package and transport the company’s microlens, making it readily accessible; these patents expire in 2030. The other patent relates to a method that could be used by a laser to cut a pocket in the cornea and insert the microlens; this patent expires in 2028. Its four pending applications relate to a method and apparatus to package and transport its microlens, to the method for laser cutting a corneal pocket to insert its microlens, to the apparatus and method to use a preloaded inserter to insert its microlens, and a system for inserting its intracorneal lens. Additionally, the company has a total of 33 foreign patent applications, 27 of which are still pending in Australia, Brazil, Canada, China, Europe, Israel, Hong Kong, India, Japan, Korea and Russia. The foreign applications correspond to the content of the six issued U.S. patents. The company owns a patent in Canada, which corresponds to the U.S. patent which covers the method and apparatus to insert its microlens, and it has granted applications in Israel and China which correspond to the same U.S. patent. It also owns patents in Japan and Australia, which correspond to the U.S. patent which covers the microlens inserter. Government Regulation The company’s medical device products are subject to regulation by the FDA and various other U.S. federal, state and non-U.S. governmental authorities, such as the competent authorities of the countries of the EEA. History Presbia PLC was founded in 2014.