TAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing that the FDA in a letter dated December 6, 2019, stated that it has determined that STAAR has provided sufficient data to support initiation of a human clinical study in the United States of the EVO/EVO+ VISIAN® Implantable Collamer® Lens for Myopia, and EVO/EVO+ VISIAN® Toric Implantable Collamer® Lens for Myopia with Astigmatism.
“STAAR looks forward to the next step in moving our trial forward, gaining Institutional Review Board (IRB) approval, and initiating the EVO/EVO+ clinical trial as soon as possible, which we anticipate will be during the first quarter of calendar 2020,” said Caren Mason, President and CEO of STAAR Surgical.
Initiating the clinical trial is an important step towards the future availability of the EVO Visian ICL family of products in the U.S. STAAR’s plan for the study includes 300 subjects with a primary endpoint at six months follow-up.
Source: Company Press Release
