OCT 20, 2015
Boston-based medical device company Avedro has resubmitted a new drug application for its riboflavin ophthalmic solution/KXL system for corneal cross-linking (CXL). The company expects a decision in April 2016.
In February 2015, an advisory committee to the FDA voted in support of Avedro’s CXL device for the treatment of keratoconus and corneal ectasia following refractive surgery. The following month, the FDA requested more information regarding the design of the device and its equivalence to the clinical study device.
“We have been working closely with the FDA and are pleased that we have been able to successfully complete the additional testing and analysis required to address the questions raised about the equivalence of the KXL device,” said David Muller, PhD, CEO of Avedro,
Although not yet approved for sale in the United States, the KXL System is being studied in Phase-3 open-label clinical trials in the United States, with an expected completion date of January 2016.