TearClear completes pre-IND meeting with FDA
TearClear and the FDA have completed a pre-investigational new drug meeting regarding development of and clinical study design for the company’s preservative-free multidose latanoprost formulation for glaucoma.
The treatment incorporates TearClear’s technology, which “offers the only means of delivering a preservative-free dose directly from preserved solutions,” the release said.
The IND filing and commencement of the pivotal registration trial are intended for 2021, according to the release.
“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.,” TearClear CEO Robert J. Dempsey said in the release. “