Successfully met the primary and all secondary endpoints
On track for New Drug Application (NDA) filing, with the FDA in Q1 2023
TC-002 is the first of four proprietary glaucoma drugs in the TearClear near term pipeline
CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- TearClear, an ophthalmic pharmaceutical company that transforms trusted drugs into branded best-in-class therapies, announced today that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%) met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023. Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.
“TearClear is responding to an important unmet need. Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD)1. This causes discomfort for patients, frustration for physicians and drives additional costs for payers,” said Stuart Raetzman, CEO of TearClear. “Switching from preserved to unpreserved glaucoma medications significantly reduces the prevalence of signs and symptoms of OSD2. In these cases, physicians want to keep well controlled glaucoma patients on the same drug, payers want to reduce the additional costs related to OSD treatment and patients want to keep multi-dose bottles. Only TearClear addresses the needs of all stakeholders.”
Developed from a platform of interconnected and proprietary technologies, TC-002 contains the preservative benzalkonium chloride (BAK) while in the bottle, but delivers pristine, preservative free drops to the eye. In the bottle, BAK maintains sterility, increases stability and aids in solubility. Because the BAK is removed from the drops as they are dispensed to the eye, the prevalence of OSD signs and symptoms can be reduced compared to the prevalence caused by drops that contain BAK.
“In glaucoma, my field of specialty, we treat the disease, in many instances with eyedrops and in many cases, multiple eye drops. And while it's essential to get these pharmaceuticals to the surface of the eye, pristine and sterile, the BAK formulas in many cases are delivering a high dose of benzalkonium chloride,” says Thomas Samuelson, MD, a founding partner of Minnesota Eye Consultants. “If we can keep the BAK in the bottle, but once the eyedrop hits the surface of the eye, it's BAK-free, that's really the best of both worlds.”
“CLEAR is a Phase 3 prospective, double masked, randomized, multi-center, active-controlled, parallel group, three-month trial evaluating the efficacy and safety of TC-002 in patients with elevated intraocular pressure (IOP),” says Srini Venkatesh, Ph.D., President, R&D and Technical Operations. “We achieved the primary efficacy endpoint, which is the difference in mean change from baseline in IOP at weeks two, six and twelve at 8:00 am, 10:00 am and 4:00 pm. We also achieved all of the secondary efficacy endpoints, which includes diurnal (average of 8:00am, 10:00 am and 4:00 pm measurements) IOP at weeks two, six and twelve.”
In the near term, TearClear is using its proprietary platform to develop a portfolio of four glaucoma drugs. In addition to TC-002 (latanoprost 0.005%), TearClear also filed an investigational new drug (IND) application for TC-003 (brimonidine/timolol) in June 2022, which the FDA has cleared for initiating the TC-003 clinical trial. TearClear plans to file additional IND applications for TC-001 (timolol) and for TC-004 (brimonidine). In the mid- and longer-term, TearClear can use the proprietary platform to develop products to treat dry eye, allergy, inflammation, presbyopia, myopia and other ophthalmic conditions.
Chief Operating Officer
Baudouin, Christophe, Detrimental effect of preservatives in eye drops: Implications for the treatment of glaucoma. Acta Ophthalmologica 2008: 86: 716-726
Jaenen, N., Baudouin, C, Pouliquen, P., Manni, Figueiredo, A., Zeyen, T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. European Journal of Ophthalmology, Vol. 17 no. d, 2007/ pp. 341 -349.