The FDA has cleared Optovue to market its epithelial thickness mapping software in the U.S. Eye doctors can use the updated software and accompanying optical coherence tomography device to automatically assess the thickness of the epithelial and stromal layers.
Optovue gained FDA clearance to sell an earlier version of the device, iVue, and accompanying software in 2013. But that version forced users who wanted to know the thickness of the epithelial and stromal layers to calculate them manually using digital calipers. The latest iteration of the iVue software automates the process and creates color thickness “maps” of the layers.
To market the revised software, Optovue sought and has now won (PDF) 510(k) clearance from the FDA. The filing paints the latest version of iVue as the same as the previously cleared model in almost all significant ways. The big difference is the change to the software.
Optovue made its case for the revised software by presenting data from two clinical trials. One of the studies assessed the thickness of the cornea, epithelia and stroma using three iVue devices to assess the repeatability and reproducibility of the mapping process.
The other study compared measurements made using the old, manual process with those generated by the new, automated software. The mean difference between epithelial thicknesses calculated by the two approaches was 0.7 µm. With the average epithelial thickness coming in at 54 µm, that amounts to a difference of 1.3%. The average differences for corneal and stromal thickness were both 0.4%.
Those data and the subsequent 510(k) clearance have teed Optovue up to go after a new market.
“I believe epi-mapping will change the way we assess the cornea since it is a very reliable indicator of ocular surface health. This noncontact approach could easily become the standard-of-care for anterior segment eye exams because epithelial irregularities often mask stromal abnormalities,” George Asimellis, Ph.D., an associate professor at the University of Pikeville in Kentucky, said in a statement.
Optovue also used the 510(k) filing to alert the FDA to other changes it has made to the device. These changes included the removal of a LCD monitor, support for Windows 7 and switch from a gigabit ethernet to USB 3 connection. The changes were small enough that Optovue made them without seeking 510(k) premarket clearance.