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 yesterday afternoon the company said it determined that the FDA is likely to require an additional, smaller trial before it would approve the Flexivue PMA
“Given our limited cash position, together with our lack of sources of additional capital, the company has determined that it will need an investor or strategic partner in order to continue pursuit of the trial and the PMA application,” Presbia said in a regulatory filing.
That means immediate layoffs for all but three employees in Irvine “to assist with the efforts to locate an investor or strategic partner and maintain the assets of the business.” CEO Michael Yung is slated to step down April 30, with board member and former CEO Zohar Loshitzer taking over the next day. In Europe, where Presbia has sites in Ireland and Germany, the wind-down is slated to take place over three months, the company said.
“During the three-month period, the company will pursue and evaluate opportunities to identify an investor or strategic partner in order to continue pursuit of the trial and the PMA application, or to otherwise monetize its intellectual property and related assets, including data collected in the FDA trial and other studies, CE Marks and related microlens and other inventory, manufacturing and other equipment, patents and trade secrets, through a potential sale or partnering arrangement,” Presbia said in the filing, adding that it expects to formally de-list its shares from the NASDAQ stock exchange as the markets open April 25.
Presbia employed 20 people as of Dec. 31, 2018, according to an SEC filing.
LENS shares, which closed down -2.0% at 54.8¢ yesterday, plunged to 27¢ even today in pre-market trading, down -50.7%.