NKCF news and happenings.
Avedro Receives FDA Approval for Photrexa® Viscous, Photrexa® and the KXL® System for Corneal Cross-Linking
Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146%, Photrexa (riboflavin 5’-phosphate ophthalmic solution) 0.146%, and the KXL system are the first and only FDA-approved therapeutic treatment for progressive keratoconus
Waltham, Massachusetts, USA, Apr 18, 2016
Avedro, Inc., an ophthalmic pharmaceutical and medical device company, has received approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa and the KXL System. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. Avedro’s Photrexa Viscous, Photrexa and the KXL System represent a first-in-class therapeutic treatment for this sight threatening indication.
Avedro Announces Resubmission of New Drug Application to FDA for Corneal Cross-Linking
Waltham, Massachusetts, USA, Sep 30, 2014
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.”
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.
Contact: David Iannetta; Avedro, Inc.; firstname.lastname@example.org; 781‐768‐3400
We’re a Great Non Profit!
The Discovery Eye Foundation (DEF), the NKCF’s parent organization, has been honored with a prestigious 2014 Top-Rated Award by GreatNonprofits, the leading provider of user reviews about nonprofit organizations.
In a report published in the academic journal Ophthalmology researchers revealed they’ve found a new layer to the human eye. Named Dua’s layer, after Professor Harminder Dua from the University of Nottingham in the U.K. who discovered it, the previously undetected sixth layer of the cornea located towards the back of cornea, between the corneal stroma and the Descemet’s membrane. While the entire cornea is around 550 microns thick (0.5mm), the new layer is just around 15 microns thick and has proved to be incredibly strong and tough which enables it to withstand about one and a half to two bars of pressure. Read more…