Ocular Therapeutix glaucoma insert fails to meet phase 3 endpoint

OTX-TP, a glaucoma treatment candidate from Ocular Therapeutix, failed to meet its phase 3 primary endpoint of statistically significant superiority in mean IOP reduction, according to a press release.

An intracanalicular insert that delivers a preservative-free travoprost formulation, OTX-TP is designed to lower IOP for up to 90 days in patients with primary open-angle glaucoma or ocular hypertension.

The double-masked, placebo-controlled phase 3 trial included 554 subjects who were treated with either OTX-TP or placebo insert. IOP reduction was measured at nine different time points: 8 a.m., 10 a.m. and 4 p.m. at 2, 6 and 12 weeks after insertion.

While the trial found that OTX-TP did not reach the primary endpoint of statistically significant superiority in IOP reduction compared with placebo at all nine time points, it did result in a greater reduction in IOP from baseline compared with placebo at all time points, with those differences being statistically significant at eight of those time points, the release said.

“We are encouraged by the results of this trial, which shows OTX-TP’s ability to lower IOP out to 12 weeks with a single insert using this novel dosage form,” Michael Goldstein, MD, chief medical officer of Ocular Therapeutix, said in the release. “We will continue to review the data from the trial, and we look forward to meeting with the FDA to discuss these results before determining the next steps in our clinical development plans.”

OTX-TP, a glaucoma treatment candidate from Ocular Therapeutix, failed to meet its phase 3 primary endpoint of statistically significant superiority in mean IOP reduction, according to a press release.

An intracanalicular insert that delivers a preservative-free travoprost formulation, OTX-TP is designed to lower IOP for up to 90 days in patients with primary open-angle glaucoma or ocular hypertension.

The double-masked, placebo-controlled phase 3 trial included 554 subjects who were treated with either OTX-TP or placebo insert. IOP reduction was measured at nine different time points: 8 a.m., 10 a.m. and 4 p.m. at 2, 6 and 12 weeks after insertion.

While the trial found that OTX-TP did not reach the primary endpoint of statistically significant superiority in IOP reduction compared with placebo at all nine time points, it did result in a greater reduction in IOP from baseline compared with placebo at all time points, with those differences being statistically significant at eight of those time points, the release said.

“We are encouraged by the results of this trial, which shows OTX-TP’s ability to lower IOP out to 12 weeks with a single insert using this novel dosage form,” Michael Goldstein, MD, chief medical officer of Ocular Therapeutix, said in the release. “We will continue to review the data from the trial, and we look forward to meeting with the FDA to discuss these results before determining the next steps in our clinical development plans.”