Presbia (NSDQ:LENS) today reported interim data from a U.S. pivotal trial of its Flexivue microlens, touting an average gain of 5 lines of uncorrected near visual acuity and 99% maintenance of binocular uncorrected distance vision.
The company reports a total of 421 subjects have been implanted with the Flexivue microlens in the trial, which is being carried out as the company seeks FDA premarket approval. Presbia said it is planning for a final PMA module submission in September 2017.
An average gain of 5 lines of uncorrected near visual acuity in treated eyes, as well as a 99% rate of maintained binocular uncorrected distance vision, according to an SEC filing.
Presbia said it is currently focusing on commercialization efforts in South Korea, with a Korean Presbia certified surgeon slated to present 1-year patient results in mid-June this year.
Last August, Presbia said it is nearing completion of enrollment in a pivotal trial of its Flexivue Microlens implant. The Dublin-based company said it had enrolled 300 patients at the time and submission of its final PMA module would come after the 24-month follow-up of the subjects.
Last February, Presbia received FDA clearance to enroll patients in the 2nd stage of a pivotal study for its Flexivue Microlens for treating presbyopia.
A month earlier 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%.
The Presbia lens won CE Mark approval in the European Union in December 2009.
