Presbia Abandons Flexivue Microlens, Lays Off All But 3
Presbia said it spiked its Flexivue microlens development program in the face of FDA headwinds, laying off all but three of its employees as it seeks investors to bail it out, according to a Mass Device report.
Earlier this month, the Irvine, Calif.-based company delayed the pre-market approval timeline for Flexivue, which is designed to treat far-sightedness or presbyopia, after the FDA asked for more information. The federal safety watchdog last October gave Presbia until April 3 to provide 36-month data from all subjects enrolled in its pivotal trial, plus additional safety and efficacy information, later extending that deadline to Sept. 30. At the time the company said it expected to complete the extra data submission of the extra information before then.
But the company said it determined that the FDA is likely to require an additional, smaller trial before it would approve the Flexivue PMA