Ocular's sustained-release insert misses bull's-eye in phase 3 glaucoma trial

Ocular Therapeutix said it plans to discuss the results with the FDA before continuing its development plans. (Pixabay)

Ocular Therapeutix’s drug-eluting insert to treat glaucoma—a small, resorbable hydrogel plug that sits within the tear duct and is designed to replace 90 days’ worth of daily eye drops—fell just short of meeting the primary endpoint of its first pivotal phase 3 trial.

The OTX-TP intracanalicular insert, which delivers the common glaucoma drug travoprost without the need for preservatives, aimed to reduce average intraocular pressure across a total of nine different time points: three daily readings taken at 8:00 a.m., 10:00 a.m. and 4:00 p.m., multiplied by check-ins at two, six and 12 weeks after its insertion.

But compared to placebo, OTX-TP was only able to statistically clear eight of the nine time points, though it lowered intraocular pressure by between 3.27 and 5.72 mm Hg in patients with primary open-angle glaucoma or ocular hypertension, with the highest levels of reduction seen earlier in the trial.

While the goal was to hit a perfect score across all nine measurements, Ocular Therapeutix said it’s still encouraged by the results—especially when compared to the poor adherence seen in daily, standard-of-care regimens, in addition to the insert being generally well tolerated with no serious adverse events of the eye being observed.

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“In our opinion, this product candidate represents a new opportunity for treating glaucoma patients that has the potential to address one of the biggest issues we deal with in clinical practice, the challenges patients have in taking eye drops,” Chief Medical Officer Michael Goldstein, M.D., said in a statement.

“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,” Goldstein said. Ocular’s stock was down by as much as 15% in premarket trading following the release to about $3.37.

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The company is also developing a longer-term implant of resorbable travoprost, also known as Travatan, which is injected into the fluid-filled anterior chamber of the eye and sits between the iris and the cornea. The implant, OTX-TIC, began its phase 1 proof-of-concept trial in May 2018 and is designed to last for four to six months.

In December of last year, Ocular secured an FDA approval for its first drug and delivery system, Dextenza, for treating pain following eye surgery. The one-time intracanalicular insert delivers the steroid dexamethasone for up to 30 days, compared to a typical post-procedure regimen of up to 70 eye drops.