Ocular Therapeutix Inc.'s late-stage study to evaluate its drug for the reduction of fluid pressure in the eye failed to meet its primary goal.
The company's phase 3 study evaluated OTX-TP, an intracanalicular insert that delivers a preservative-free formulation of travoprost, in 554 patients with open-angle glaucoma or ocular hypertension.
Glaucoma is characterized by increased pressure in the eye that can damage the optic nerve leading to blindness. Travoprost eye drops are used to treat high pressure inside the eye, specifically in patients with open-angle glaucoma.
The results showed that the drug did not significantly reduce fluid pressure in the eyes of the treated patients compared with placebo insert treated patients at nine different time points at each of two, six and 12 weeks following insertion.
However, the drug did reduce intraocular pressure on the treated patients compared with placebo at eight of the nine prespecified time points.
The Bedford, Mass.-based company plans to continue its review of the data from the study and discuss the results with the U.S. Food and Drug Administration before determining the next steps in the clinical development plans.