TearClear Announces Successful Completion of Pre-IND Meeting
/TearClear Announces Successful Completion of Pre-IND Meeting with the FDA for a Preservative Free Multi-Dose Delivery of Latanoprost for the Treatment of Glaucoma
Prepared to file an IND in mid-2021 via the 505(b)(2) NDA pathway
Boston, MA, US, Dec 1, 2020 —
TearClear, an emerging ophthalmic pharmaceutical company, today announced the successful completion of pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for the preservative-free multi-dose delivery of a proprietary Latanoprost formulation, including the clinical study design for the registration study.
“We are pleased with the outcome of the Pre-IND meeting and look forward to preparing the IND filing and commencing our pivotal registration trial in 2021,” said Robert Dempsey, Chief Executive Officer, TearClear. “The successful completion of this engagement with the FDA is an important milestone for the company and provides clarity and confidence as we advance our lead clinical program in the U.S.”
Read the remainder of the company’s press release here. Or a PDF archive copy is available here.
Shared by Tyler Stowater, board member of TearClear Corp.