FDA Announces Plans for LASIK Quality of Life Project

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

“This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

“Many people in the U.S. undergo LASIK procedures,” said Shuren. “Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements.”

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FDA Approves Besivance to Treat Bacterial Conjunctivitis

The U.S. Food and Drug Administration today approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

“Bacterial conjunctivitis is a common condition that affects people of all ages,” said Wiley A. Chambers, M.D., acting director of the Division of Anti-Infective and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others.”

Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms of bacterial conjunctivitis can include red eyes, swelling, eyelids sticking together, itching, watering and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis is generally a condition that runs its course in 7-14 days.

Patients using the drug in clinical trials had a faster rate of resolution of the infection than those treated with a solution containing only a preservative. The drug was shown to be effective in treating patients age one year and older.

Adverse events were reported in less than 3 percent of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache. Besivance is an eye drop for topical use on the eyes only. It should not be injected into the eye.

Besivance is made by Bausch & Lomb, Rochester, N.Y.

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