As far back as the early 1960s, researchers toyed with the idea of delivering medication through contact lenses.

Johnson & Johnson Vision (NYSE:JNJ) Director of Clinical Science Dr. Brian Pall told Drug Delivery Business News that patents back then disclosed how a soft contact lens of hydrogel material could be an effective vehicle for delivering medication to the eye.

On March 2, well over half a century since the notion was floated, Johnson & Johnson announced that the FDA approved its Acuvue Theravision with the antihistamine Ketotifen. It’s the first drug-eluting contact lens authorized for marketing in the U.S.

Already approved in Japan and Canada, Acuvue Theravision with Ketotifen is the world’s first contact lens of its kind, according to Pall.

“[Eye drops] are just not a super-efficient way to deliver medication to a target tissue,” Pall said. “That’s what I believe is the primary reason so many people have been looking into how to develop a drug-eluting contact lens. I’m certainly proud to be part of the team that was able to finally get it across the finish line.”

Acuvue Theravision with Ketotifen lenses are daily disposable contacts indicated to prevent ocular itch due to allergic conjunctivitis. They provide vision correction in patients who do not have red eyes, are suitable for contact lens wear, and do not have more than 1.00 D of astigmatism.

Pall said that, during the manufacturing process, the drug itself is integrated and uniformly distributed throughout the contact lens. As a result, it doesn’t have an odor or any kind of appearance, making it look and feel just like any other contact lens.

Each lens has a 19 μg dose and, when placed, the lens has a release profile that helps prevent the itch associated with ocular allergies. Whereas eye drops can be blinked out and may not reach the target tissue as effectively, the lens has a quick release in which the drug diffuses out in the first hour to be absorbed by ocular tissues.

Over the following hours, the remaining amount of the drug releases at a slower rate for sustained therapy, leading to a clinically proven duration of action that totals up to 12 hours.

“The relief profile is very effective at having that quick onset of action as well as that longer duration of action,” Pall said.

Pall said the Johnson & Johnson Vision team’s research showed that 40% of contact lens wearers suffer from itchy eyes, and, in talking to those patients, the team found that 80% are frustrated by the way it interferes with their everyday activities.

Through hearing patient feedback and stories from doctors, Pall and the team found that eye drops were considered inconvenient to use

“We felt like this is an opportunity to really bring some relief, freedom and benefit to patients who are either unable to wear contact lenses during allergy season or are just suffering through lenses while suffering from their allergies,” Pall said. “This isn’t just a spring pollen kind of phenomenon. … We want to understand the unmet need and develop the products that can help address that. This is an example of that, and I’m really excited and proud that we were able to hit this historic achievement.

Pall said that the Johnson & Johnson Vision team worked with the company’s Janssen pharmaceutical business to integrate the drug into the lens. It wasn’t all seamless, as he said it “requires quite a bit” to ensure that the drug remains stable when incorporated into a lens.

Another challenge came in identifying the correct pairing of drug material and contact lens material. The team had to fine-tune the material and dosage, then scale from a few thousand lenses for a clinical trial to hundreds of thousands ready for a global market launch.

“We had to find the right combination of manufacturing processes as well as the combination between the drug and the lens,” Pall said. “There’s a significant amount of engineering and science that happens to make sure that was all done properly and consistently. Across all the different functional areas, whether clinical engineering, chemistry, manufacturing — each one of those functional areas all kind of hit their goals and milestones in order to make this happen.”

Because of the specificity of the drug and material partnership, the contact lens technology isn’t purely plug-and-play.

For that reason, Johnson & Johnson Vision can’t immediately place another drug into the contact lens technology to treat another disease, but the company will continue to look into expanding the platform to offer even more therapeutic options.

“We believe in the technology, and we believe in the idea that delivering a medication through a medical device to the eye is a potentially more optimal way to treat some types of eye diseases,” Pall said. “We are definitely continuing to look at and work on different areas that we think can really continue with this momentum and with this line of innovation.”

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance Tagged With: janssen, Johnson & Johnson, Johnson & Johnson Vision

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