The FDA is considering changes in current no-rub policies, the pre-market testing of products and labeling of contact lens care products. The FDAs Ophthalmic Devices Panel met on June 10 to address safety and compliance issues related to the incidence of Acanthamoeba and Fusarium keratitis. It heard testimony of representatives from ophthalmic organizations, including the American Optometric Association and
In April 2006, 180 cases of suspected Fusarium keratitis were reported. Of the 94% of infected patients who wore soft lenses, those with confirmed Fusarium keratitis were about 20 times more likely to report using ReNu with MoistureLoc, the Centers for Disease Control and Prevention (CDC) found. Bausch & Lomb voluntarily discontinued the solution.
Between May 2006 and May 24, 2007, 138 cases of Acanthamoeba keratitis were reported to the CDC. These patients were seven times more likely to be using Complete MoisturePlus, as estimated by the CDC, prompting Advanced Medical Optics to recall the product.
The organizations recommend that the FDA work closely with industry to expand and strengthen contact lens solution and product testing. Recommendations include:
Updating contact lens solution testing, which would ensure efficacy against a more diverse and representative set of infectious organisms, including Acanthamoeba.
Making contact lens solution testing more rigorous, by including standardized real-world scenarios, such as effectiveness while in a contact lens case and sustained efficacy after the solution evaporates.
Adopting a standardized and validated testing protocol, to ensure that contact lens products are meeting the same demands. The post-recall era is a very different one for the FDA and the entire contact lens industry, says Arthur B. Epstein, O.D., who testified at the hearing. There is general recognition that new testing protocols must better approximate real world conditions while recognizing the increased complexity of interactions between modern materials, lens cases and solutions.
Re-examining the concept of equivalency testing (determining if new products are similar to existing approved products), when a revised formula is submitted. Each product should be evaluated individually.
Making labeling changes, regarding guidelines on reusing or topping off solutions; rub and rinse time; case care; water activity, including showering, using a hot tub or swimming; and noncompliance.
We are supportive of the FDA in making changes to help protect the sight of Americans, says William J. Benjamin, O.D., who spoke on behalf of the AOAs Commission on Ophthalmic Standards. We support the FDA in requiring that products be tested under more realistic conditions, when feasible, and in situations where lens wearers are not compliant with a doctors instructions. We also support the agencys review of labeling requirements for care products.
