Here are three of the papers presented at the recent ASCRS conference, all of which examine the use of iTrack Advance for angle closure glaucoma.
The first paper shown here is the same as the one mentioned in the ASX announcement last year as having only 82 patients, however as of last month it now has 367 according to the paper. Great to see how fast the sample size is growing. I don't have the actual poster from last year to determine how many patients there were for angle closure specifically last year, however 45 is a decent sample size already for FDA approval, as they will most likely take the 510(K) route which is much less stringent in terms of data requirements. The other papers below also provide further evidence highlighting the high efficacy and safety of the procedure. Particularly for IOP reduction, 36% reduction in IOP is massive. 20% is usually regarded as the standard. Most eyes were completely free of medication as well after the procedure.
Given how fast they seem to be getting more eyes to test here, I would say they should quickly have sufficient data to make an application for FDA approval for closed angle glaucoma well before 12 months, depending of course on how much data they intend to have going into the approval process.
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Here are three of the papers presented at the recent ASCRS...
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