The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical trial, as well as additional safety and efficacy information, before it can complete its premarket approval application review, according to an SEC filing.
Presbia submitted its final pre-market approval module to the FDA during the second quarter of last year, including 24-month data for the Flexivue device, saying it expected the PMA bid to go through during the fourth quarter of 2018 before submitting final 36-month data during Q1 2019.
But the agency said on October 5 that it would require the 36-month data before it could finish its review of the PMA, Presbia said in an Oct. 12 SEC filing. The federal watchdog gave the company until April 3, 2019 to respond.
This week, Presbia said that it still needs additional time to submit the data to the FDA, and added that it got a 180-day extension, according to an SEC filing.
The company said that it expects it will complete the submission of the extra information before the September 30 extension date, but added that there is “no assurance” that it will be granted PMA approval, according to the filing.
Shares in Presbia have dropped 10.1% so far today, at 63¢ as of 10:09 a.m. EDT.