Staar Surgical announced that leading refractive ophthalmic societies in Germany and Japan have increased the diopter range for recommended use of phakic refractive lenses, including the EVO Visian ICL, to -3.0 diopters from -6.0 diopters.
The German society, the Kommission Refraktive Chirurgie (KRC), meaning Commission of Refractive Surgery, which is a joint commission of two leading German ophthalmic societies, the BVA (Berufsverband der Augenärzte Deutschlands) and the DOG (Deutsche Ophthalmologische Gesellschaft), (i) expanded the recommended range for use of phakic refractive lenses, including the EVO Visian ICL, from -6.0 diopters (KRC’s prior recommendation) to -3.0 diopters, and (ii) expanded the ‘border’ recommended range for use from -3.0 diopters (KRC’s prior recommendation) to -1.0 diopters. Separately, the Japanese Ophthalmological Society modified its surgical indication criteria for recommended use of phakic IOL, such as the EVO Visian ICL, from -6.0 diopters to -3.0 diopters.
“Germany and Japan are two highly-respected countries known for their high regulatory standards, precision and quality,” Caren Mason, President and CEO of Staar Surgical, said in the news release. “Historically, phakic intraocular lenses were reserved for patients with high levels of myopia (greater than or equal to -6.0 diopters) or those patients who did not qualify for corneal refractive procedures such as PRK or LASIK. We are delighted that these esteemed medical societies have updated their guidelines to reflect their review of contemporary clinical evidence of safety and effectiveness of phakic refractive lenses, including the EVO Visian ICL family of lenses and support its use in patients with moderate levels of myopia, which previously was reserved primarily for corneal refractive procedures. These recent decisions are consistent with a growing number of ophthalmic refractive surgeons who are selecting EVO lenses as a premium and primary solution for suitable patients with low, moderate or high myopia seeking visual freedom from spectacles and contact lenses.”
“We are pleased with the modified KRC recommendations and see ample growth opportunities in the lower diopter segment of refractive vision correction for the EVO Visian ICL,” said the EVO Visian ICL Expert Group based in Germany. The group consists of Drs. Martin Bechmann, Johannes Gonnermann, Laszlo Kiraly, Gero Krommes, Tobias Neuhann, and Amir Parasta.
“The modifications of KRC recommendations are in line with international practice for the EVO Visian ICL where low diopters are a focus of refractive growth,” said Dr. Alonso Juarez of Spain. “I am pleased that after reviewing the clinical data, the Japanese Ophthalmological Society modified its guideline for use of the EVO Visian ICL to include lower diopters in the -3D to -6D range. We believe that EVO is an important and useful addition to the refractive options available for these patients in Japan,” said Dr. Kazutaka Kamiya of Japan.
These decisions do not change the approved labeling of use in either country; rather, they reflect the contemporary positioning of phakic refractive lenses, such as the EVO Visian ICL family of lenses, for patients with low to moderate myopia (distance vision correction needs). EVO is the latest version of Staar Surgical Company’s implantable Collamer lens (ICL) that works with the patient’s natural eye to correct vision and provide patients visual freedom from spectacles and contact lenses.