WALTHAM, Mass.--(BUSINESS WIRE)--Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company announces today that it resubmitted its New Drug Application (NDA) for riboflavin ophthalmic solution/KXL® System to the U.S. Food and Drug Administration (FDA). Avedro anticipates an application action date (PDUFA) in March 2015. This resubmission is a comprehensive reply to questions and requests from the March 2014 complete response letter.
The proposed indications of treatment of progressive keratoconus or corneal ectasia following refractive surgery were both granted orphan status by the FDA in 2011. Patients with these sight threatening conditions may require corneal transplant surgery. If approved, riboflavin ophthalmic solution/KXL System would be the first FDA approved therapeutic treatment for these orphan indications, and entitle Avedro to seven years of US market exclusivity.
“US ophthalmic surgeons are pleased to hear of this next step in the process with the FDA,” said Peter Hersh, MD, Hersh Vision Group, Teaneck, NJ and Avedro Medical Monitor. “Cross-linking represents an important treatment option that addresses an unmet medical need. US patients and their ophthalmologists eagerly await the availability of corneal cross-linking.”
“We have been working closely with the FDA to address the issues raised in the complete response letter. We are very pleased to be able to resubmit the NDA and answer the questions that were posed to the Company,” said David Muller, PhD, CEO of Avedro. “Treatment for keratoconus and corneal ectasia represents an important step for Avedro as we work to develop a full portfolio of corneal cross-linking treatments.”
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.
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 IROC Innocross UV-X devices, the KXL® System for performing Lasik Xtra® and accelerated cross-linking, the KXL II™ System for performing PiXL™, and a portfolio of proprietary single dose pharmaceuticals, including the VibeX and MedioCROSS 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.