Presbia (NSDQ:LENS) said it received FDA clearance to enroll patients in the 2nd stage of a pivotal study for its Flexivue Microlens for treating presbyopia.
Presbia said it’s continuing to track patients implanted with the lens during the 1st stage of the trial.
“With this approval, we will continue enrollment in our pivotal trial taking us one step closer towards gaining FDA approval of our product in the U.S.,” said Presbia CEO Todd Cooper, in a statement. “Pending FDA approval, we intend to make the Presbia Flexivue Microlens commercially available to U.S. presbyopic patients to improve their near vision, and to reduce their dependency on reading glasses.”
The Presbia lens won CE Mark approval in the European Union in December 2009.
Late last month, Presbia raised less than the $50 million midpoint it set for its initial public offering, pricing its 4.2 million-share IPO at $10 rather than $11 to $13. Total proceeds were $42 million. LENS shares closed at $6.67 apiece yesterday, up 0.6%.