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New lenses, please!
As an American surgeon, I am always impressed at the American Academy of Ophthalmology meeting with all the great, new technologies in the exhibit hall but saddened to see that so many are available only to doctors and patients outside the U.S.
Lens implants are one prominent example, and among the products I covet the most are the toric lenses. In the U.S., just two companies offer toric lens implants: Alcon and STAAR Surgical. The U.S. Food and Drug Administration approved these two toric lens lines many years ago, but since then, the toric pipeline has been clogged by seemingly unnecessary red tape.
Sometimes I wonder whether the FDA suffers from bipolar disorder. When a new product concept, such as a toric lens, comes the first time before the agency, it is often approved fairly quickly. After a short experience with any new product, though, we discover both its benefits and its limitations. In the case of toric implants, rotational instability was one problem with the earliest lens designs that has since been fully addressed. The FDA, instead of allowing different companies to come forth with new toric lenses, effectively stopped up the product pipeline, imposing unrealistic testing and validation requirements on new toric lenses that the originally approved designs might never have passed.
How many times has the FDA exhibited this manic-depressive behavior? It has certainly happened with accommodating implants. Eight years after approving the Crystalens (Bausch + Lomb) in 2003, there remains no other approved accommodating lens in the U.S. despite approval and commercial success in Europe of the Tetraflex (Lenstec) and the Synchrony implant (Abbott Medical Optics).
It now appears that the approval of new multifocal lenses may be under threat, as the FDA has suggested it may require proof that any new multifocal implant can provide the same contrast (measured as modulation transfer function) as a monofocal lens. If
the agency really imposes this unrealistic requirement, it may mean that no more multifocal lenses will ever be approved. And toric multifocals? Forget about it.
This type of manic-depressive regulation has already proven to be pointless. In the years since the approval of the first-generation toric, accommodating and multifocal lenses, literally hundreds of thousands of these implants have been used around the globe, and their safety has been inarguably proven in the hands of physicians. It's a great loss to patients here that many of their newer counterparts may never be approved in the U.S. - the very country that developed these new technologies.
One of the most important advocacy roles we as American physicians can play is to demand our lawmakers close a technology gap brought about by a regulatory agency that has been tasked with serving the people but has delivered only the technology of yesteryear.
- Disclosure: Dr. Hovanesian is a consultant for Bausch+Lomb and Abbott Medical Optics.