It’s snowing or sleeting all along the Eastern seaboard today, with no end in sight until tomorrow, when the FDA’s Ophthalmic Devices Panel was scheduled to vote on whether to recommend approval for the Toric ICL device to treat myopic astigmatism.
The weather prompted the federal watchdog agency to indefinitely postpone the panel meeting, Monrovia, Calif.-based Staar said today.
"The agency has assured the company that it intends to reschedule the meeting as soon as practically possible," according to a press release.
In a review of Staar’s pre-market approval application released ahead of the meeting, the FDA expressed concern about a series of deviations from the protocol for the study used to back the PMA bid. The agency issued a warning letter in April 2004 after an inspection of a plant in Monrovia in December 2003 cited Staar for "failure to obtain FDA approval prior to initiating a study, failure to ensure continuing Institutional Review Board (IRB) review and approval, failure to obtain signed Investigator Agreements from participating investigators, and failure to provide participating Clinical Investigators with all the information required to perform the study," according to the pre-meeting materials.
A follow-up inspection in March 2007 prompted another warning letter that June, citing "a number of major deviations" including the fact that "one of the investigational sites had significantly modified the FDA approved protocol," according to the materials.
"In addition, there were omissions, errors, and inconsistencies in the clinical study data that raised concerns regarding the validity and reliability of the data submitted to the FDA in support of STAAR’s PMA for the TICL, which was filed on May 8, 2006," according to the materials.
A "data integrity hold deficiency letter" followed, with the FDA asking for an independent, 3rd-party audit of the clinical data and Staar’s system. The 3rd-party reports came in October 2008 and March 2009, after which the FDA cleared a corrective action plan and lifted the integrity hold. Review of the PMA application then resumed, according to the materials.
But the FDA issued a non-approvable letter in November 2011 "due to major concerns related to the inconsistency of the study database, low subject accountability, large number of protocol deviations, and failure to submit adequate software and mechanical validation studies," according to the agency. After Staar’s November 2012 response promised to establish a single, consistent post-audit database, the PMA app was back under review, but in March 2013 "it was revealed that Staar had made unapproved design changes to the TICL device," according to the FDA.
"Staar informed FDA that these changes had occurred sometime before 2004, which means that some of the subjects in the clinical trial were implanted with this modified device while others were implanted with the originally approved design," the FDA said. "Follow-up conversations with the applicant to clarify this issue resulted in new information that raised additional concerns regarding this clinical study."
The agency wants the advisory panel to consider whether there’s enough data to asses the safety and effectiveness of the Toric ICL implant. The FDA isn’t bound by the recommendations made by its advisory panels, but often follows their lead in its final decisions.