California startup ClarVista Medical said Monday it won CE Mark approval in the European Union for its Harmoni modular intraocular lens designed to correct aphakia in adult patients who have had a cataractous lens removed.
The modular intraocular lens is designed to reduce residual postoperative refractive error at either the time of primary surgery or 3-months post-operatively, the Aliso Viejo, Calif.-based company said.
“While these are noteworthy regulatory milestones achieved by ClarVista, this news is also of great significance for physicians and patients around the world who seek optimum vision after cataract extraction. Despite significant innovation in instruments that safely remove the cataract from the eye, the fundamental IOL design has not changed in more than five decades. Today’s IOLs are simply no longer able to meet the high expectations of patients and physicians. There is significant unmet need for an advanced IOL system that can satisfy the visual needs of patients around the globe. We designed this system to be easily and safely exchangeable without manipulation of the delicate capsular bag and this feature, by itself, will deliver great value to the market. However, we think we can go well beyond that and have shown the promise to more accurately hit refractive targets after initial implantation of the Harmoni Modular IOL system. Early data also point towards significant reduction in the development of secondary cataracts, a common reason for deteriorating vision post-operatively. We are also working hard on adding further value to our platform technology. The Harmoni Modular IOL system really has the opportunity to disrupt the $3B global market for IOLs,” co-inventor Dr. Malik Kahook of the University of Colorado said in a press release.
ClarVista said that in addition to receiving CE Mark approval, it also received ISO 13485 certification.
“CE Mark approval and ISO 13485 certification are very important milestones for us and validate the dedication of the entire ClarVista team to deliver innovative products of the highest quality. These milestones are an important part of achieving our vision of having the HARMONI Modular IOL system be the ophthalmologist’s first choice for every cataract patient,” CEO Paul McLean said in prepared remarks.
In May, ClarVista said it raised a $14 million Series B round for development of its intraocular lens replacement. Cycad Group and Windham Venture Partners co-led the round, along with existing investor New Enterprise Associates, ClarVista said.