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FDA approval of surgical treatment for meibomian gland disease: A boon for patients and physicians alike
North Carolina-based TearScience today announced the FDA approval of its LipiFlow thermal pulsation system for treating meibomian gland disease. This device is designed to apply heat to the inside of the eyelids while simultaneously compressing them from both internally and externally in a pulsatile manner. It is designed not only to maximally express the sluggish meibomian glands in this disease, but also to stimulate their continued spontaneous flow to provide sustained relief of symptoms following the treatment. The fairly comfortable 12-minute procedure is performed in the ophthalmologist’s office, and patients treated in the FDA study were found to have at least several months of significant improvement in symptoms.
This new development is great news for dry eye sufferers and physicians alike for several reasons. First, the therapeutic device (LipiFlow) will be coupled with a diagnostic device (called LipiView by TearScience) that is designed to aid in patient selection. This will hopefully take much of the guesswork out of treating dry eye by defining what degree of lipid vs. aqueous secretion is present. Well-selected patients will hopefully be very satisfied with the results of treatment. Second, the system is designed to express the sludge from these stopped-up glands much more efficiently than is possible with manual methods. Expressing glands manually is a task that most ophthalmologists avoid because it is painful for the patient and highly unpleasant for the physician. Finally, this represents the only treatment for meibomian gland disease that has been specifically examined and approved by the FDA.
It is likely that LipiFlow treatment will not be covered by Medicare or third-party insurance carriers, at least in the beginning. Because it is a self-pay procedure, patients will be demanding of genuine relief. So far, the data looks very promising that this will be the case, at least in well-selected patients.
At this time in history when FDA approvals of new drugs and devices come about as frequently as an eclipse, we should all celebrate the approval of this important new treatment.
- Disclosure: Dr. Hovanesian is a consultant and member of the medical advisory board to TearScience, the maker of LipiFlow.