Staar Surgical scopes out FDA approval for LASIK alternative implantable lens

Years after initially setting its sights on FDA approval for the latest version of its implanted vision-correcting lens, Staar Surgical has finally reached the regulatory milestone.

The Evo/Evo+ Visian implantable collamer lens is indicated to treat myopia, or nearsightedness, with or without astigmatism. The lenses are meant to stand in as an alternative to other vision correction options like glasses, contacts and more invasive LASIK surgery.

Staar’s quest for U.S. approval of the lens dates back several years. It first applied for FDA review in 2019 but was hit in May of that year with a response letter concluding that the application “lacked information, particularly the clinical evidence and analysis,” necessary to approve the Evo lens.

In August 2019, the FDA greenlighted a new clinical study of the lens, pushing back the estimated timeline for its approval to mid-2021 at the earliest—much later than initial predictions, which put approval as early as the end of 2019.

After all the back and forth, with premarket approval finally secured and announced this week, Staar’s stock price has surged to nearly its highest price all year—topping $84 as of Tuesday morning—though it’s still well below the all-time high of about $156 that was set last September.

The Evo device is implanted directly between the iris and the crystalline lens in the posterior chamber of the eye. In contrast to previous versions of Staar’s implantable lens technology, placement of the Evo lens is a quick procedure that no longer requires a preoperative peripheral iridotomy, in which a laser is used to create a hole in the iris.

It also differs from LASIK surgery, according to Scott Barnes, M.D., Staar’s chief medical officer, in that it doesn’t require the removal of corneal tissue and “is removable by a doctor if ever desired.”

The newly FDA-approved alternative to both LASIK and standard contacts and glasses is especially necessary, Barnes said, since myopia is becoming increasingly common. Some forecasts suggest almost half the world’s population could experience some form of nearsightedness by 2050.

So far, the Evo has already been implanted in more than 1 million patients outside of the U.S. Staar estimates that nearly one-third of the U.S. population—or about 100 million people—could be eligible to receive the device, encompassing patients between the ages of 21 and 45 who have myopia greater than -3.0 D and the willingness, financial ability and physical proximity to a see a certified surgeon to undergo the procedure.

With premarket approval under its belt, Staar is already moving full steam ahead with the U.S. rollout of the Evo lens, CEO Caren Mason said in a statement.

“Surgeons will be trained and certified for Evo and begin implanting Evo in the coming days and weeks in select cities,” Mason said. “Commercialization of Evo in the U.S. will begin immediately and be supported by a nationwide advertising, marketing and public relations campaign.”