FDA responds to Avedro NDA

March 25, 2014

Avedro Inc. has received a complete response letter from the FDA regarding the new drug application (NDA) for its riboflavin ophthalmic solution/KXL System.

 

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.

 

For more articles in this issue of Ophthalmology Times eReport, click here.

 

 

To receive weekly clinical news and updates in ophthalmology, subscribe to the Ophthalmology Times eReport.