FDA Takes Major Step to Save Vision

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FDA one step closer to final approval for sight saving treatment that could help hundreds of thousands across U.S. San Antonio eye surgeon Dr. Parkhurst, MD plays key role in gaining panel approval.

“As a corneal surgeon, having the ability to stop a blinding eye disease with such a gentle and proven technology is extremely gratifying, and I am thankful to the FDA Panel for making this key recommendation.” - Dr. Parkhurst

Patients with a blinding eye disease known as Keratoconus may soon see vision-saving relief thanks to a recommendation on February 24, 2015 by the Food & Drug Administration (FDA) Panel to approve Corneal Collagen Crosslinking (CXL), said San Antonio eye surgeon, Gregory Parkhurst, MD who treated the first keratoconus patients in the United States during a corneal collagen crosslinking clinical study.¹ This treatment acts as a chemical bond to strengthen the cornea which has been weakened by keratoconus.

“This week’s recommendation by the FDA Panel to approve Corneal Collagen Crosslinking represents tremendous hope for thousands of patients across the country – many right here in San Antonio – who are at risk for blindness due to keratoconus and other forms of ectasia,” said Dr. Parkhurst. Keratoconus is the most common corneal dystrophy in the United States, affecting one in every 2,000 Americans, which represents over 136,000 people.

Dr. Parkhurst pointed out that there are more than 63 registered studies across the United States related to Corneal Collagen Crosslinking, including his at Parkhurst NuVision in San Antonio. “We are currently actively enrolling keratoconus patients into our FDA monitored clinical trial right here in San Antonio, and look forward to the day when we gain full FDA approval for this vision-saving procedure.”

“As a corneal surgeon, having the ability to stop a blinding eye disease with such a gentle and proven technology is extremely gratifying, and I am thankful to the FDA Panel for making this key recommendation,”he said. Dr. Parkhurst and Houston-based ophthalmologist Stephen Slade, MD were the first surgeons in the country to treat keratoconus patients as part of a national clinical trial by the American-European Congress of Ophthalmic Surgery (AECOS) and Avedro, Inc. Dr. Parkhurst has a pattern of leadership in gaining recommendations for FDA approval of modern medical technologies. Testimony from him and other experts at a similar FDA Panel last year resulted in a recommendation for approval of the Toric Implantable Contact Lens (ICL), which can help people suffering from nearsightedness and astigmatism.

Keratoconus is a degenerative eye disorder where the corneas of the eye become progressively thinner and cone-shaped, which damages vision. Common symptoms are light sensitivity, dry eyes, corneal scarring, blurred or distorted vision and the presence of myopia (nearsightedness) and astigmatism.

Corneal Collagen Crosslinking was developed in 1998 by German ophthalmologist, Theo Seiler, MD and has been shown in numerous clinical trials to strengthen the cornea using a photosensitizer (Riboflavin – a form of vitamin B-2), which is followed by a treatment with ultraviolet (UV-A) light.

Dr. Parkhurst has been actively involved in crosslinking FDA clinical trials, and also in the fields of cataract and vision correction surgery. Parkhurst NuVision, an optometrically supported integrated health care delivery system, is one of South Texas’ fastest growing LASIK and cataract centers, and was recently recognized as The First LensAR Laser Cataract Surgery Center of Excellence in the United States. Because of his total commitment to advancing treatments for his patients, and involvement in these developments, Dr. Parkhurst has been selected as the first eye surgeon in Texas to meet the criteria to serve as a Certified VisionLock surgeon. To be chosen for the VisionLock program, surgeons must meet 30 FDA, state, local and practice certification criteria and have a superior performance record. Less than 5% of eye surgeons nationwide meet VisionLock requirements and provide patients this visual results outcomes insurance coverage free of charge.

“Having expanded access to Crosslinking, an outpatient procedure that prevents me from having to do a major corneal transplant surgery, is a huge leap forward for all of my patients with keratoconus,” Dr. Parkhurst said.

For additional information about this press release, please visit http://www.sanantonio-lasik.com or contact Jesse Montoya at 210-615-9358.

1: American Society of Ophthalmic Administrators, February 25, 2015; http://www.asoa.org/news/joint-panel-recommends-fda-approval-drug-device-combination-cxl-progressive-keratoncus-and


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Michael Malley
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