Presbia (NSDQ:LENS) last week delayed the timeline for FDA approval of its Flexivue Microlens for treating far-sightedness after the federal safety watchdog said it wanted another year’s worth of data on the device.
Irvine, Calif.-based Presbia submitted its final pre-market approval module to the FDA during the second quarter, including 24-month data for the Flexivue device, saying it expected the PMA bid to go through during the fourth quarter before submitting final 36-month data during Q1 2019.
But the agency said Oct. 5 that it’s requiring the 36-month data before it will finish its review of the PMA, Presbia said in an Oct. 12 regulatory filing. Taking the typical 180-day PMA review process into account, which would kick off with the expected filing of Presbia’s response on April 3, 2019, “the company does not anticipate PMA approval prior to the fourth quarter 2019.”
The news sent LENS shares down -17.2% to $1.1547 per share today in mid-morning trading.