TC-002 meets endpoints in phase 3 glaucoma trial
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TC-002, a latanoprost ophthalmic solution, met all primary and secondary endpoints in the phase 3 CLEAR pivotal trial, according to a press release from TearClear.
TC-002 contains benzalkonium chloride while it is in the bottle to maintain sterility, increase stability and aid in solubility, but the preservative is removed from the drops as they are dispensed in the eye, reducing the prevalence of signs and symptoms of ocular surface disease that can be caused by drops with preservatives.
The glaucoma drug met the primary efficacy endpoint of difference in mean change from baseline in IOP at weeks 2, 6 and 12 at three daily timepoints. It also achieved all secondary endpoints, including diurnal IOP at weeks 2, 6 and 12.
“Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD). This causes discomfort for patients, frustration for physicians and drives additional costs for payers,” TearClear CEO Stuart Raetzman said in the release. “Switching from preserved to unpreserved glaucoma medications significantly reduces the prevalence of signs and symptoms of OSD. 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.”
TearClear plans to file a new drug application with the FDA for TC-002 in the first quarter of 2023.
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