According to the company, latanoprost ophthalmic solution 0.005% successfully met the primary and all secondary endpoints, and it plans to file an NDA with the FDA in Q1 2023.
TearClear announced recently 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 said in a news release it plans to file a New Drug Application (NDA) with the 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.
Stuart Raetzman, CEO of TearClear, said the company 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,” Raetzman said in a news release. “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.”
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,” Thomas Samuelson, MD, a founding partner of Minnesota Eye Consultants, said in a news release. “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.”
Srini Venkatesh, PhD, the company’s president of R&D and Technical Operations, noted that 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 IOP.
“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 am, 10 am and 4 pm,” Venkatesh said in the release. “We also achieved all of the secondary efficacy endpoints, which includes diurnal (average of 8 am, 10 am and 4 pm measurements) IOP at weeks 2, 6 and 12.”
In the near term, TearClear is using its proprietary platform to develop a portfolio of four glaucoma drugs. In addition to 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.