Inotek to re-evaluate utility of trabodenoson in glaucoma treatment

Trabodenoson added to latanoprost in a fixed-dose treatment for glaucoma yielded “no meaningful clinical advantage” in a phase 2 trial, according to an Inotek Pharmaceuticals press release.

The randomized, double-masked, dose-ranging trial compared combinations of trabodenoson at 3% and 6% and latanoprost at 0.005% and 0.0025% with latanoprost alone for reducing IOP in patients with ocular hypertension or primary open-angle glaucoma. The study period was 8 weeks.

After 28 days of once-daily morning treatment with the fixed combination of trabodenoson 3% and latanoprost 0.005%, IOP lowering was greater than with latanoprost alone; however, after 4 additional treatment weeks and nighttime dosing, no advantage over latanoprost alone was observed.

“While the top-line results ... demonstrated a good safety and tolerability profile of the fixed-dose combinations of trabodenoson and latanoprost, the efficacy of the [fixed-dose combination] was only marginally differentiated from that of latanoprost alone,” David P. Southwell, Inotek president and CEO, said in the release.

He added that these results coupled with previous study results for trabodenoson in the phase 3 MATrX-1 monotherapy trial have prompted the company to evaluate “the future clinical potential of trabodenoson as well as other strategic options.”

Trabodenoson added to latanoprost in a fixed-dose treatment for glaucoma yielded “no meaningful clinical advantage” in a phase 2 trial, according to an Inotek Pharmaceuticals press release.

The randomized, double-masked, dose-ranging trial compared combinations of trabodenoson at 3% and 6% and latanoprost at 0.005% and 0.0025% with latanoprost alone for reducing IOP in patients with ocular hypertension or primary open-angle glaucoma. The study period was 8 weeks.

After 28 days of once-daily morning treatment with the fixed combination of trabodenoson 3% and latanoprost 0.005%, IOP lowering was greater than with latanoprost alone; however, after 4 additional treatment weeks and nighttime dosing, no advantage over latanoprost alone was observed.

“While the top-line results ... demonstrated a good safety and tolerability profile of the fixed-dose combinations of trabodenoson and latanoprost, the efficacy of the [fixed-dose combination] was only marginally differentiated from that of latanoprost alone,” David P. Southwell, Inotek president and CEO, said in the release.

He added that these results coupled with previous study results for trabodenoson in the phase 3 MATrX-1 monotherapy trial have prompted the company to evaluate “the future clinical potential of trabodenoson as well as other strategic options.”