Keratoconus advocacy groups applaud FDA approval of corneal crosslinking

Process can halt progressive eye disease

April 21, 2016

The National Keratoconus Foundation (NKCF) and the International Keratoconus Academy of Eye Care Professionals (IKA) welcome the US Food and Drug Administration’s approval this week of a new treatment for keratoconus, corneal crosslinking.

Keratoconus is a sight-threatening, progressive eye disease that affects approximately 1 in 750 individuals.  The disease can damage the cornea of both eyes where the collagen, which makes up approximately 95 percent of the cornea, becomes structurally weakened. This results in an abnormal bulging and thinning of the corneal tissue. The end result is progressively worsening and distorted vision.  

The FDA’s approval on April 18, 2016 is the latest chapter in a process that has taken close to 20 years since the procedure was first performed by eye surgeons in Dresden, Germany. The procedure has been available in Europe and much of the world for more than a decade.

Known as CXL, the procedure uses a combination of riboflavin eye drops (vitamin B2) and a controlled amount of ultraviolet light to strengthen the weak corneal structure and arrest the progressive nature of the disease. The pharmaceutical and medical device company Avedro, Inc, of Waltham, Mass., led the clinical testing efforts and secured the FDA approval for its crosslinking products.

Based at the UC Irvine Health Gavin Herbert Eye Institute, the National Keratoconus Foundation is the center for public awareness and information for the keratoconus community. 

“Thousands of Americans affected by progressive keratoconus were thrilled to hear this news,” said Executive Director Mary Prudden of the importance of the FDA approval. “Many candidates for this treatment are in school or are just beginning their professional lives. They are aware that CXL has had excellent results and is the standard of care for treatment in more than 60 countries. Their only options have been to find a clinical trial that would enroll them or to seek CXL treatment outside the U.S.” 

The Gavin Herbert Eye Institute participated in the Avedro-sponsored clinical trials used as the basis for the FDA’s approval.

“In our trials, we found overwhelmingly positive response with exceptional safety,” said Dr. Sam Garg, associate clinical professor of cataract, corneal and refractive surgery at Gavin Herbert Eye Institute. “In general, patients had a stabilization of their keratometry (a measurement of the cornea’s curvature) with no evidence of progression during the study period.”

Keratoconus is more common in individuals under 40 and currently has no cure.  Common refractive corrections such as glasses or soft contact lenses usually do not improve vision; most patients require specialty contact lenses.  In up to 20 percent of the individuals affected by keratoconus, the corneal weakening can become so extreme that they require a corneal transplant from a human donor.

The International Keratoconus Academy of Eye Care Professionals (IKA) is a society of optometrists, ophthalmologists, and other eye care providers who treat keratoconus patients.  Dr. Andrew Morgenstern, FAAO, the president of the Optometric Cornea, Cataract and Refractive Society (OCCRS) and member of the IKA Executive Board, has followed the FDA approval process.

“The approval of CXL will now enable eye care practitioners to treat our patients in a method that has been proven to be not only safe and effective worldwide, but the only proven way to halt this all too common disease in its tracks,” he said.

Dr. S. Barry Eiden, FAAO, president of IKA stated “The approval of CXL further emphasizes the importance of very early diagnosis of keratoconus in order to potentially prevent vision loss from this disease. It has, without a doubt, created a paradigm shift in the management of keratoconus by eye care professionals.”

The National Keratoconus Foundation and International Keratoconus Academy have created a task force to publish treatment guidelines for use of corneal cross-linking in patients with progressive keratoconus.  For more information about CXL, visit www.nkcf.org and www.keratoconusacademy.com

The National Keratoconus Foundation is a 30-year-old organization, recently relocated to the UC Irvine Health Gavin Herbert Eye Institute, dedicated to promoting research efforts into the causes and treatment for keratoconus, raising public awareness, and giving caring support to those living with this condition.  Visit www.nkfc.org for more information about the Foundation

International Keratoconus Academy For Eye Care Professionals is a professional society, headquartered in Deerfield, IL, whose mission is to promote eye care professional’s education and scientific development in the areas of keratoconus.  Visit The Keratoconus Academy for more information.

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