FDA approves first drug-eluting contact lens
Johnson & Johnson Vision Care announced that the FDA has approved its Acuvue Theravision with Ketotifen daily disposable contact lenses.
Each lens is made of etafilcon A material and contains 19 mcg of the antihistamine ketotifen, the company said in a press release. Already available to patients in Japan and Canada, these are the first drug-eluting contact lenses approved by the FDA.
The company stated that Acuvue Theravision with Ketotifen daily disposable lenses are “indicated for the prevention of ocular itch due to allergic conjunctivitis and provide vision correction in patients who do not have red eyes, who are suitable for contact lens wear and who do not have more than 1.00 D of astigmatism.”
Phase 3 clinical trials showed a “clinically and statistically meaningful reduction in itchy allergy eyes as quickly as 3 minutes after lens insertion and lasting up to 12 hours; however, the lens may be worn longer than 12 hours for vision correction,” according to the release.
“Ocular allergic itch in contact lens wearers may soon be an issue of the past thanks to the decision of the FDA in approving Acuvue Theravision with Ketotifen,” Brian Pall, OD, MS, FAAO, director of clinical science for Johnson & Johnson Vision Care, said in the release. “These new lenses may help keep more people in contact lenses, since they relieve allergic eye itch for up to 12 hours, without the need for allergy drops, and provide vision correction.”
J&J North American President Thomas Swinnen commented in the release: “This approval marks another significant milestone in Johnson & Johnson Vision’s legacy of rethinking what’s possible with contact lenses to meet the visual and eye health needs of people around the world.”
The company did not comment on when the lenses would be available for eye care providers to prescribe.
Perspective
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Ketotifen and etafilcon A have independently enjoyed decades of proven, successful use in millions of eyes around the world, and now a marriage of the two brings the first drug-eluting contact lens to reality. I can't deny this long-awaited launch of a new market category deserves a level of excitement and curiosity, and there is security in using these familiar, time-tested components with our patients. At the same time, I also can't help but wonder if Acuvue Theravision with Ketotifen is outdated before it even hits office shelves. Although ketotifen and etafilcon A are still widely used, neither of these elicits a sense of innovation or best-in-class status in the mind of today's clinician. Undoubtedly, this lone drug-eluting contact lens option will be appealing to patients who are highly motivated to find drop-free eye allergy relief, and, in turn, there will be a definite place for Acuvue Theravision in our practices. However, in many cases – even in patients who would prefer to not use eye drops – I'm not yet convinced that fitting a patient in Acuvue Theravision will prove to be an all-around easier or more effective approach for the eye care provider or the patient than choosing one of the many contemporary lens designs (not limited to spherical single vision lenses in a hydrogel material) along with, for example, a dose of a newer antihistamine prior to lens insertion.
It is always a win to have new tools in our toolbox to address patient symptoms and to potentially improve our patients’ contact lens wearing experience. As such, I'll welcome this latest addition to the Acuvue family. Time will tell, but Acuvue Theravision’s ultimate value to eye care may lie in simply being the first in a new category, launched by a large, global company who has the reach to bring awareness to this new category. Acuvue Theravision will help pave the way and define a market space for better products to come.
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