Waltham, MA—Avedro Inc. has received a complete response letter from the FDA regarding the new drug application (NDA) for its riboflavin ophthalmic solution/KXL System.
Additionally, in the response letter, the agency identified several areas of the application that require additional information.
“We plan on working closely with the FDA to resolve these issues as quickly as possible to make this important treatment available to patients in the United States,” said David Muller, PhD, chief executive officer of Avedro. “While we do not yet have an estimate on how long it will take to resolve the issues, we are confident that we can adequately answer their questions.
“However, we continue to grow internationally by bringing advanced corneal cross-linking (CXL) procedures to ophthalmologists and patients around the world. This expansion also includes the development and refinement of our (technology) for photorefractive intrastromal CXL,” Dr. Muller continued.
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