If FDA follows its panel’s recommendation and grants marketing approval for Visian Toric, California ophthalmic devices maker Staar Surgical will hold the only lens approved in the U.S. for placement in the posterior chamber (ciliary sulcus) of the phakic eye for myopia and astigmatism.
Panelists voted 5 in favor that there is a reasonable assurance of safety, with 1 no and 3 abstentions. They voted 7 in favor of effectiveness, with 1 no and 1 abstention. On Visian Toric’s benefits outweighing risks, 6 panelists voted yes and 3 abstained.
This is not Visian Toric’s 1st time at bat with the FDA, according to background materials released ahead of the meeting. The federal watchdog agency in 2012 denied marketing approval for the lens after Staar Surgical failed to meet requirements for post-approval study data. Visian Toric was initially approved in 2005, subject to post-approval study data from 3 studies.
The 1st post-approval study was to monitor for device-related corneal endothelial cell loss for 5 years and Staar was asked to provide yearly reports on this data. FDA in 2011 approved Staar’s report on the results of this study, but ultimately denied the company’s proposed device labeling revision in 2012 "based on a number of concerns regarding the analysis used to describe the endothelial cell density (ECD) development. The applicant has yet to provide FDA with their response to the labeling concerns," the agency stated.
Staar was also tasked with monitoring adverse events under conditions of general use in a second 5-year post-approval study of Visian Toric, including cataract formation, corneal decompensation, persistent elevated retinal detachment, chronic uveitis and secondary surgical interventions (e.g., lens exchange, lens explantation, repositioning). This 2nd study, which is ongoing, involved enrollment of 5,000 U.S. patients in order to obtain 5-year follow-up on at least 2,000 patients.
Finally the company was asked to conduct a pre- and post-operative axial length measurement sub-study to determine whether Visian Toric affects this measurement. The FDA in 2011 approved Staar Surgical’s proposed updates to device labeling based on this 3rd sub-study.
Visian Toric is already approved in a number of countries around the world, and Staar recently notched Japanese regulatory approval for a new version of the lens implant featuring CentraFLOW technology, which the company called a "key driver to our growth of Visian ICL revenues the past several quarters," according to a company press statement. CentraFLOW allows physicians to treat a larger range of patients with the Visian ICL, expanding to myopia starting at -3.0 diopters, up from the current range at -5.0 diopters, according to a press release.