Pharmaceutical company files IND application with FDA for glaucoma candidate
A late clinical stage ophthalmic pharmaceutical company is tackling glaucoma, filing an investigational new drug (IND) application with the FDA.
TearClear filed the application to conduct a registrational study for its lead glaucoma candidate, TC-002 latanoprost ophthalmic solution 0.005%.
According to the company, 30% to 40% of patients who rely on preserved, chronic glaucoma therapies show signs of moderate to severe ocular surface disease (OSD).1
Moreover, studies have suggested that removal of preservatives may be beneficial for the ocular health of such patients. To date, options for these patients have been less than adequate.
The company claims that it is the first and only company to develop products that keep BAK preserved formulations safely in the bottle and deliver pristine, preservative free drops of trusted medicines to the eye.
“We are confident that improving the health of the ocular surface matters,” TearClear CEO Stuart Raetzman said in a statement. “Responding to that unmet need has propelled us to this important milestone and it is what drives us to expand our efforts for other glaucoma therapies and to important therapies beyond glaucoma that intersect with OSD.”
The company also points out that preservatives, such as benzalkonium chloride (BAK), are critical in ophthalmic solutions to maintain sterility and stability in the bottle. However, on the ocular surface, they have been reported to be associated with adverse effects like hyperemia, tear film instability and conjunctival inflammation potentially leading to meibomian gland dysfunction (MGD).
By eliminating preservatives on the ocular surface, the company pointed out that the potential for long term deleterious effects on the eye are eliminated.
1. Hawk Partners, July 2019