FDA puts the brakes on Avedro with complete response letter on KXL System

Avedro has had the brakes put on alternative applications of its KXL System by the FDA, which issued a complete response letter less than two weeks after the company received additional financing to help it expand into the U.S. market.

The privately held Boston-based company said in a release the federal agency had a number of questions regarding Avedro's application that would require additional information. It did not specify what questions the FDA had regarding the product.

Just under two weeks ago, Avedro received $43 million in Series D financing to help boost the company's research and development into multiple indications for its products, and also support U.S. and international sales efforts.

The company's technology is available internationally, but not yet in the U.S., and involves a concept called "corneal crosslinking." Its Vedera system CE, marked since April 2010, uses thermal energy (rather than surgical incisions in the eye) to flatten the cornea to treat both myopia and cornea bulging by reshaping and flattening the cornea. Avedro's KXL System, CE marked in November 2010, uses similar technology to treat a degenerative eye disorder known as keratoconus and also enables an enhanced Lasik procedure.

Avedro chairman David Muller said in a release the company plans on working closely with the FDA to resolve the issues as quickly as possible, however, they "do not yet have an estimate on how long it will take to resolve the issues."

- read the release

Suggested Articles

InterVene secured $15 million to validate its catheter-based treatment for correcting failed one-way valves in the veins of the legs.

LabCorp, Philips and Mount Sinai are coming together to develop an AI-driven pathology center of excellence, aimed initially at cancer diagnosis.

The FDA followed through with plans to end its Alternative Summary Reporting program, making 20 years’ worth of device safety data publicly available.