TearClear announces the successful initiation of its TC-002 Latanoprost Ophthalmic Solution Phase 3 trial
BOSTON, Feb. 07, 2022 (GLOBE NEWSWIRE) -- 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.”
About Preservative Free
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 potential for long term deleterious effects on the eye are eliminated.
TearClear is an ophthalmic pharmaceutical company that transforms trusted drugs into best-in-class therapies. TearClear is the only branded ophthalmic pharmaceutical company that keeps preservatives safely in the bottle and delivers pristine, preservative free drops on to the ocular surface. TearClear therapies will help the millions of patients who rely on chronic eye drops and who also suffer from ocular surface disease. For more information, visit TearClear and connect with us on LinkedIn: LinkedIn.
- Hawk Partners, July 2019