First European NTC Medical Product for Dry Eye Disease Approved by the FDA

First European NTC Medical Product for Dry Eye Disease Approved by the FDA

December 16, 2021

NTC Srl and I-MED Pharma announced that I-Defense, a lubricating ointment containing 0.4% sodium hyaluronate indicated for the relief of dry eyes and lagophthalmos symptoms has been successfully registered with the FDA.

It is the first European NTC ophthalmic medical device to be approved in the United States.

The successful partnership between NTC and I-MED Pharma to deliver this revolutionary ophthalmic ointment first to Canada and now the United States is a testament to both companies' commitment to improving the science of dry eye.

I-DEFENSE® is now one of many dry eye medications in the I-MED Pharma portfolio that has been approved by the FDA, with more to follow in the near future.

The unique viscous properties of I-DEFENCE® enable a prolonged contact-time with the ocular surface. This hydrating ointment provides soothing relief of dry eye symptoms, such as soreness, irritation or a gritty sensation on the eyes and acts as a barrier against moisture loss. It can be used during surgical procedures and is ideal for patients that suffer from nocturnal lagophthalmos.

“We are proud of our strategic partnership with a leading ophthalmic company such as I-Med Pharma,” in North America, Riccardo Carbucicchio, President and CEO of NTC, states. “We started our cooperation in Canada, and now we are excited that one of our innovative products for eye diseases will now become available to many patients in the U.S.A.” he adds.

Philipp Binder, President and Chief Operations Officer of I-MED Pharma commented, “We are excited about our collaboration with NTC to bring a leading HA-based ophthalmic ointment to the United States market. Both I-MED Pharma and NTC are equally committed to research and development within the ophthalmic space.

“We look forward to making this innovative dry eye ointment available exclusively through eye care professionals within the USA to help execute on our mission to bring complete relief to dry eye and ocular surface disease patients worldwide.”