FDA Approves Implantable Collamer Lens for Correction of Myopia

FDA approves the EVO/EVO+ Visian Implantable Collamer Lens for the correction of myopia and myopia with astigmatism.

The FDA has approved the EVO/EVO+ Visian Implantable Collamer Lens (STAAR Surgical Company) indicated for the correction of myopia and myopia with astigmatism.

The EVO lens is indicated for the treatment of phakic eye in patients aged between 21 and 45 years to correct or reduce myopia among individuals with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane and to correct or reduce myopic astigmatism in patients with spherical equivalent ranging from -3.0 D to -20.0 D with cylinder of 1.0 D to 4.0 D at the spectacle plane.

“Over one million EVO lenses have already been implanted by doctors outside the US and 99.4% of EVO patients in a survey have stated they would have the procedure again,” Caren Mason, president and CEO of STAAR Surgical, said in a press release. “The EVO lens is additive, provides excellent quality of vision day and night, does not cause dry eye syndrome and is removable by a doctor, if ever so desired.”

Further, the EVO lens is indicated for patients who have an anterior chamber depth of 3.00 mm or greater, as measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 D for 1 year prior to implantation).

The implantable collamer lenses have been used to improve vision for more than 20 years globally, according to STAAR Surgical Company. The EVO lens is implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens.

Prior versions of the intraocular lens required a preoperative peripheral iridotomy, which the EVO removes the need for. Additionally, EVO provides a lens-based alternative to correct or reduce refractive error among individuals currently using glasses and/or contact lenses to correct distance vision. Safety of the lenses for myopia was confirmed in a multicenter, prospective clinical investigation, according to STAAR Surgical Company.

In an additional statement, Scott D. Barnes, MD, Chief Medical Officer of STAAR Surgical stated their thrill to make EVO available to US surgeons and patients looking for an option to glasses, contact lenses, or laser vision correction.

“Today’s announcement is especially important because the prevalence of myopia is increasing quickly, and COVID precautions have presented additional challenges to people wearing glasses and/or contact lenses,” Scott D. Barnes, MD, chief medical officer of STAAR Surgical, said in a press release. “EVO adds an important tool for the ophthalmic surgeon seeking to help improve a patient’s quality of life.

“Moreover, the EVO lens is removable by a doctor if ever desired. Results from our recent US clinical trial are consistent with the more than one million EVO lenses that have already been implanted around the world.”

Reference

STAAR Surgical Announces U.S. FDA Approval of EVO Visian® Implantable Collamer® Lenses. Business Wire. [news release]. March 28, 2022. https://www.businesswire.com/news/home/20220328005207/en/STAAR-Surgical-Announces-U.S.-FDA-Approval-of-EVO-Visian%C2%AE-Implantable-Collamer%C2%AE-Lenses