Staar Surgical (NSDQ:STAA) shares are down more than 10% after the company said it received a letter from the FDA’s Center for Devices and Radiological Health requesting more data for the premarket approval application supplement for its EVO/EVO+ Visian implantable collamer lenses for myopia and myopia with astigmatism.
The federal watchdog said that the supplement lacked information, “particularly the clinical evidence and analysis,” that would allow for the completion of the review, the Monrovia, Calif.-based company said in an SEC filing.
Without the extra information, the FDA will not be able to complete the review and estimate “whether there is a reasonable assurance of the device’s safety and effectiveness for its intended use,” Staar Surgical said in an SEC filing.
The company said that it plans to continue discussions with the FDA, including discussing concerns about the existing PMA supplement and what new clinical data may be required, according to an SEC filing.
Shares in Staar Surgical have fallen approximately 11.4% so far today, at $24.93 as of 11:17 a.m. EDT.
In February, Staar Surgical said that it inked a strategic cooperation agreement with ophthalmology clinic group Vista Oftalmólogos to offer its Evo Visian implantable collamer lenses for patients suffering from nearsightedness.
