FDA Asks For More Data On Avedro, Inc.'s Eye Therapy System
3/18/2014 8:49:39 AM
Avedro Announces Receipt of Complete Response Letter from FDA for Corneal Cross-Linking NDA
WALTHAM, Mass.--(BUSINESS WIRE)--Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company announces that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for their riboflavin ophthalmic solution/KXL® System. In the complete response letter the agency identified a number of areas of the application which 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 US,” said David Muller, PhD, CEO 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 procedures to ophthalmologists and patients around the world. This expansion also includes the development and refinement of our KXL II™ system for Photorefractive Intrastromal Cross-Linking (PiXL™).”
Keratoconus, an orphan indication, is a potentially blinding disease, for which limited therapeutic treatment is available in the US. Corneal ectasia is a rare outcome of refractive surgery (such as LASIK) and is a progressive condition that is difficult to manage. Patients with these sight threatening conditions may require corneal transplant surgery. If approved, the riboflavin ophthalmic solution/KXL System would be the first FDA approved therapeutic treatment for these orphan indications.
About Avedro, Inc.
Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal cross-linking and refractive correction. Avedro’s products include capital equipment and related single dose pharmaceuticals. The KXL System’s cross-linking, in combination with its pharmaceuticals, is used to treat keratoconus and corneal ectasia outside the United States. Those products are also used in a procedure known as Lasik Xtra®. Over 75,000 surgeries have been successfully performed outside the US using Avedro’s KXL System.
Avedro distributes its products in 62 countries through 33 ophthalmic distributors with 115 sales and service representatives. Avedro products that have received CE Mark include: the KXL System for performing Lasik Xtra and Accelerated Cross-linking, the KXL II System for performing PiXL, and the Avedro family of proprietary single dose pharmaceutical formulations.
Avedro’s KXL System and single dose pharmaceutical products are currently being used in three Phase III US clinical trials involving over 100 US clinical sites. Avedro products are not for sale in the US.
David Iannetta, 781-768-3400
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