Staar Surgical (NSDQ:STAA) said today it won CE Mark approval in the European Union for its Evo+ Visian ICL intraocular lens with Aspheric Optic technology, and reported that a presbyopia study of the device is underway.
The Monrovia, Calif.-based company’s EVO+ Visian ICL is the company’s next-gen lens, designed to be surgically implanted and operate with the patient’s eye to correct vision. The lens is designed to be positioned inside the eye between the iris and natural lens where it stays indefinitely.
The EVO+ Visian ICL won indications for correcting or reducing hyperopia and myopia between +3 and -18 diopters, Staar Surgical said.
“We are very pleased with the CE Mark approval for the EVO+ Visian ICL with Aspheric Optic. We plan to introduce this lens to a select group of surgeons for Early Effectiveness Observational use. This beta analysis is designed to elicit surgeon feedback on their experience with the EVO+ Visian ICL with Aspheric Optic including overall performance, patient acceptance, and practice development. This represents an important new treatment option for eligible patients between 21 and 45 years of age living with nearsightedness or farsightedness. This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to build our growing EVO Visian ICL portfolio,” prez & CEO Caren Mason said in a press release.
Staar Surgical said that it has already engaged in a 1st-in-man clinical trial of the EVO+ Visian ICL lens exploring the use of the device to reduce presbyopia.
“Earlier this week, we hosted leading global surgeons at our new STAAR Technology Center, sharing the science behind our Collamer material technology and early findings of our Presbyopic initial clinical trial. The surgeons were pleased with this investigational use only preview and impressed with the data. Later this year, we plan to initiate the pivotal clinical trial supporting the applications for the new EVO+ Visian ICL for correction or reduction of presbyopia,” Mason said in a prepared statement.
