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.