FDA Approves Implantable Collamer Lens for Myopia Correction

US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the EVO/EVO+ Visian Implantable Collamer Lens for the correction of myopia and myopia with astigmatism.

The approval for the lenses was granted to STAAR Surgical Company, a manufacturer of implantable lenses and companion delivery systems for the eye.

“Over one million EVO lenses have already been implanted by doctors outside the U.S. and 99.4% of EVO patients in a survey have stated they would have the procedure again,” said Caren Mason, President and CEO of STAAR Surgical in a statement accompanying the approval. “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.”

The implantable collamer lens has been indicated for use in phakic eye treatment in patients aged 21 - 45 years for the correction/reduction of myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane and for the correction/reduction of 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.

Additionally, the lens is indicated for use in patients with an anterior chamber depth of 3.00 mm or greater, when 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 release stated that STAAR Surgical’s implantable Collamer lenses have been used for vision improvement for more than 20 years globally. The EVO procedure is implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens.

Although earlier versions of the intraocular lens required a preoperative peripheral iridotomy, the company noted this is now eliminated with EVO. Further, EVO offers a lens-based alternative for the correction/reduction of refractive error in people currently using glasses and/or contact lenses for distance vision correction.

The safety of EVO lenses for myopia was confirmed in a US multicenter, prospective clinical investigation.

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,” Barnes said. “EVO adds an important tool for the ophthalmic surgeon seeking to help improve a patient’s quality of life.

Barnes noted the differences from LASKI and the quick surgical procedure in which the lens is added to a patient’s eye without removal of corneal tissue.

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