MONTREAL—NTC, a pharmaceutical company with headquarters in Italy, and I-MED Pharma Inc., a Canadian company specializing in dry eye diagnosis and management, have announced that I-Defense, a long-lasting, lubricating ointment for the relief of dry eyes and lagophthalmos symptoms, has been successfully registered with the FDA. It is the first European NTC medical device product for ophthalmic use approved in the U.S., according to a recent joint announcement. (Lagophthalmos is the incomplete or defective closure of the eyelids.)

The I-Defense ointment contains 0.4% sodium hyaluronate. The viscous properties of this product enable a prolonged contact-time with the ocular surface. This hydrating ointment provides soothing relief of dry eye symptoms and acts as a barrier against moisture loss, the companies said.
NTC and I-MED Pharma’s successful collaboration to bring this innovative ophthalmic ointment first to Canada and now to the U.S. “is a testament to the dedication of both companies to advancing the science of dry eye,” the announcement noted.
I-Defense is one of many products in the I-MED Pharma dry eye portfolio that has been successfully registered with the FDA, “with more to follow suit in the near future,” the companies said.
“We are proud of our strategic partnership with a leading ophthalmic company such as I-Med Pharma,” Riccardo Carbucicchio, NTC’s president and CEO, said. “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.”
Philipp Binder, president and chief operations officer of I-MED Pharma, added, “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 eyecare professionals within the USA to help execute on our mission to bring complete relief to dry eye and ocular surface disease patients worldwide.”