We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Complete Response Letter Blocks Approval of Avedro’s Eye Drug-Device Kit
Complete Response Letter Blocks Approval of Avedro’s Eye Drug-Device Kit
The FDA has rejected Avedro’s NDA for its riboflavin ophthalmic solution/KXL System, saying additional data supporting the drug-device combo’s efficacy and safety are required for approval.