What happened
Shares of STAAR Surgical (STAA -0.77%) were surging 10.9% higher as of 11:17 a.m. ET after rising as much as 19.4% earlier in the day. The big gain came after the company announced that the U.S. Food and Drug Administration (FDA) approved the EVO/EVO+ Visian Implantable Collamer Lens for correcting myopia (nearsightedness) and myopia with astigmatism.
So what
STAAR Surgical needed some good news. The healthcare stock had fallen more than 60% from its peak, set in September 2021, as of earlier this month. The FDA approval for EVO provided a well-deserved boost.
EVO has already won regulatory approvals outside of the U.S. Over 1 million EVO lenses have been implanted in other countries. STAAR's ex-U.S. momentum has been picking up, with EVO sales increasing 51% year over year in 2021.
The company should have a tremendous opportunity in the U.S. market. It's estimated that there are around 100 million U.S. adults between the ages of 21 and 45 who are potential candidates for EVO.
STAAR was already banking on FDA approval of EVO. Its full-year 2022 revenue guidance was for $295 million, a 28% year-over-year increase.
Image source: Getty Images.
Now what
STAAR Surgical plans to immediately launch EVO in the U.S. The company will support this launch with a national marketing campaign. However, there's more involved than just getting the word out about EVO. STAAR also must train surgeons on how to implant the lenses.
It expects to quickly begin training and certifying surgeons for EVO implantations in select U.S. cities.
