Inotek “Transforming Glaucoma Treatments”

CHICAGO—Inotek is committed to “transforming glaucoma treatments,” David Southwell, president and CEO, said here during the Ophthalmology Innovation Summit. Glaucoma is a $5.6 billion worldwide market with well-recognized low compliance among patients on topical therapies.

Inotek’s trabodenoson is a novel adenosine mimetic that stimulates a natural pathway; early studies indicated no dose-related side effects in a monotherapy trial and a clear dose response with good ocular and systemic safety in a Phase II trial.

“Trabodenoson showed an ability to dose QD or BID, and an additive efficacy to prostaglandins,” Southwell said. The company’s first Phase III monotherapy study (MATrX-1) is evaluating both QD and BID against placebo, with results expected before year-end.

Half of the US glaucoma market is dominated by prostaglandins, with an average 6 to 8 mm Hg drop in pressure levels from baseline; the remaining half is a combination of adjunctive agents that include beta blockers, alpha agonists, and carbonic anhydrate inhibitors.

Trabodenoson, however, binds to the A1 receptors on the trabecular meshwork and upregulates matrix metalloproteinase-2, “digesting the extracellular matrix proteins that clog the trabecular meshwork,” Southwell explained.

A Phase II study found trabodenoson 500 mcg statistically lowered intraocular pressure (IOP) at all time points on Day 28, with low and unchanged hyperemia scores across all doses.

MATrX-1 enrolled about 300 patients for 12-week treatment; entry IOP was at least 24 mm Hg. The study is evaluating three doses of trabodenoson: 1000 mcg QD, 2000 mcg QD, and 1500 mcg BID, and comparing outcomes with timolol 0.5% BID and placebo.

The first fixed-dose combination therapy trial began in July 2016. This Phase II trial of trabodenoson with latanoprost has enrolled about 165 subjects with either ocular hypertension or primary open-angle glaucoma with baseline IOPs between 25 mm Hg and 34 mm Hg. Data readout is expected during the second half of 2017.

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