Presbia pivotal Microlens trial nears end

Presbia (NSDQ:LENS) said Monday it is nearing completion of enrollment in a pivotal trial of its Flexivue Microlens implant designed to treat presbyopia and is on track to  submit its final pre market approval module.

The Dublin-based company said it has enrolled 300 patients, and submission of its final PMA module will come after the 24-month follow-up of the subjects.

“Completion of enrollment for our pivotal study is progressing on schedule, moving toward a timely submission to obtain FDA approval. This step is an important milestone in securing FDA approval to market the Flexivue Microlens to consumers in the U.S.,” CEO Todd Cooper said in a press release.

In 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.

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