FDA approval for CXL

The US Food and Drug Administration (FDA) is tasked to assure the safety and effectiveness of medical devices sold in the United States. The roots of the current FDA were planted in 1906 when President Theodore Roosevelt signed the Pure Food and Drugs Act. Initially the act had a very narrow focus limited to the prohibition of the adulteration and misbranding of foods and drugs. Over the decades, the FDA has evolved into an agency that safeguards the health of the American people.

According to the FDA, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” In addition to the rigorous scrutiny applied prior to approval, the FDA also performs post-marketing drug safety surveillance. In doing so, they can spot problems not identified in trial studies; including low frequency reactions, those individuals in high-risk groups, long-term effects, and drug-drug/food interactions.

Without FDA approval, doctors and patients alike would have no way to ensure that the medication or treatment their doctor recommends is safe and effective. Currently, only the epithelium off version of collagen crosslinking is FDA approved because it demonstrated safety and efficacy in a prospective, randomized, multicenter, controlled clinical trial. Epithelium on procedures are considered experimental and are not FDA approved and thus not covered by health insurance companies. Patients who choose cross linking with iLink™ from Glaukos can rest assured that they will receive the safest and most effective treatment along with insurance coverage. As a board certified cornea specialist I have treated hundreds of patients with Keratoconus without having their condition progress to the point of needing a corneal transplant. With the FDA approval and proven efficacy collagen cross linking with the iLink™ is the best way to stop keratoconus in its tracks.

Avagen Letter To Patients

August 11, 2021

As a fellowship-trained cornea specialist, my focus over the last 21 years has been on keratoconus.  I have always believed in providing state-of-the-art care for all cornea patients.  I was the first ophthalmologist in Tampa to offer corneal cross-linking for keratoconus when it was first FDA approved in the spring of 2016.  Since then, I have successfully performed over 400 cases and been able to halt the progression in the majority of patients. Based on long term studies, those patients will likely never need a cornea transplant. 

 I am now very excited to be the first ophthalmologist in the Tampa Bay Area to offer the AvaGen genetic eye test for keratoconus.  AvaGen will provide a new level of targeted and personalized care for patients at risk for keratoconus.  Keratoconus is an inherited condition with an autosomal dominant inheritance pattern, but with incomplete penetrance.  Autosomal dominant inheritance means that approximately half of the children of a person with keratoconus will inherit the gene. Of those who carry the gene, a certain percent will develop the disorder.  About 20% of patients in one study reported a close family member with keratoconus.  Other studies claimed a positive family history for keratoconus ranging from 3% to as high as 28%.  Of the 20% in the study who said they had a close family member with keratoconus, 53% had one other family member and 46% reported two or more family members with keratoconus.  

This new genetic testing is recommended for all family members of affected keratoconus patients.  It is a simple in-office mouth swab which provides results in one to two weeks.  It gives a keratoconus risk assessment and score with categories of no risk, low, medium or high risk for keratoconus.  Genetic counseling is available for those at risk or with positive test results. Early diagnosis will allow for earlier intervention and prevention of visual loss from this disease.   I encourage all family members of a person diagnosed with keratoconus to call your local cornea specialist and arrange for a screening exam with genetic testing.

Sincerely,

Craig E. Berger, M.D.

Craig Berger, MD