■ TearClear has announced filing of an Investigational New Drug (IND) application for a registrational study of TC-002, the company’s lead glaucoma candidate latanoprost ophthalmic solution, 0.005%. According to a news release, the company is the first and only to develop a way of delivering benzalkonium chloride (BAK)-preserved formulations of established agents to the eye without BAK. The first-in-class drug platform enhances patient safety and compliance by capturing preservatives before they reach the ocular surface, keeping them in the bottle via a proprietary “smart preserve system,” the company said.
Approximately 30% to 40% of patients chronically taking preserved glaucoma therapies have signs of moderate to severe ocular surface disease, according to the news. Although studies have suggested that removing preservatives may benefit ocular surface health, adequate alternatives remain elusive.
“There is a reason that the overwhelming majority of our eye-drop bottles contain preservatives: they work,” said Nathan M. Radcliffe, MD, a glaucoma specialist at New York Eye Surgery Center. “At the same time, we know that preservatives outlive their usefulness the moment the medication leaves the tip of the bottle. TearClear has solved this problem in an ingenious way, giving our patients the best of both worlds.”
Preservatives are known to be associated with hyperemia, tear film instability, and conjunctival inflammation that may lead to meibomian gland dysfunction. Removing preservatives from the ocular surface reduces the long-term adverse impact on the eye. The company stated that its lead product candidates in glaucoma will “pave the way for future indications across multiple programs in development.”