Minimally Invasive Glaucoma Device Guidance Finalized
This article was originally published in The Gray Sheet
The "leap frog guidance” outlines clinical and non-clinical testing recommendations for the nascent field of minimally invasive glaucoma surgical (MIGS) devices. It closely matches a February draft guidance.
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Glaukos held its first earnings call Aug. 12 following the completion of its $113 million IPO, which closed in June. The firm is the first to the U.S. market with a micro-invasive glaucoma surgery, or MIGS, device and it is working to get its next-generation system that can be performed separate from cataract surgery to market in the coming years.
FDA issued a "leap frog" draft guidance for minimally invasive glaucoma surgery (MIGS) devices based on strong interest in the nascent field from manufacturers. The recommendations under the guidance reflect discussion during a 2014 stakeholder workshop.