TearClear, a late clinical stage ophthalmic pharmaceutical company, is pleased to announce the TC-002 Phase 3 trial has been successfully initiated. TearClear’s Phase 3 trial (CLEAR Study) is a prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TC-002 Ophthalmic Solution (TearClear Preservative-Free Latanoprost Ophthalmic Solution 0.005%) compared to marketed Latanoprost Ophthalmic Solution 0.005%.
TearClear has developed a novel investigational platform through which topical ophthalmic solutions are preserved in a patient-friendly multi-dose bottle but are delivered to the ocular surface as preservative-free.
Approximately 30%-40% of patients who rely on preserved, chronic glaucoma therapies show signs of moderate to severe Ocular Surface Disease (OSD)1. 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. Thomas Samuelson, MD at Minnesota Eye Consultants commented, “Up until now, the preservative-free options available to patient are accompanied with compromises related to cost and ease of use. TearClear’s approach offers patients the best of both worlds, where preservatives remain in the bottle but kept off the ocular surface.”
TearClear 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. “Enrolling the first subjects is an important milestone,” Stuart Raetzman, TearClear’s CEO stated. “We are optimistic that this will allow us to bring the only product to market that keeps BAK safely in the bottle while delivering pristine, preservative-free drops to the eye.”
TearClear is an ophthalmic pharmaceutical company that is transforming trusted drugs into best-in-class therapies. Our lead product candidates in glaucoma will pave the way for future indications across multiple programs in development. This versatile platform enables medication delivery to ultimately enhance patient safety and compliance by capturing preservatives before they reach the ocular surface. For more information, visit TearClear and connect with us on LinkedIn.
About Preservative Free
Preservatives, such as benzalkonium chloride (BAK), are necessary in ophthalmic solutions to maintain sterility. 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 removing preservatives from the ocular surface, the potential for long term deleterious effects on the eye are reduced. TearClear offers the only means of delivering a preservative-free dose directly from preserved solutions.
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- Patrick Crowley