Inotek Pharmaceuticals has closed patient enrolment in the Phase II clinical trial of fixed-dose combination (FDC) of trabodenoson and latanoprost to treat patients with glaucoma.
Trabodenoson is a highly selective adenosine mimetic developed to increase the natural function of the trabecular meshwork for reducing the intraocular pressure (IOP)
The prostaglandin analog latanoprost is designed to target the secondary uveoscleral pathway.
The randomised, double-masked, dose-ranging Phase II trial enrolled around 200 patients.
The trial will evaluate the overall benefit / risk profile of the combination therapy given via binocular topical application to patients with ocular hypertension or primary open-angle glaucoma for eight weeks.
Inotek president and chief executive officer David Southwell said: “We have completed active recruitment of glaucoma patients in our Phase II FDC trial.
“This is an important milestone as we continue to believe our FDC programme has the potential to address a larger market opportunity than monotherapy, and provide patients with a novel treatment option that includes two complementary eye pressure lowering mechanisms."
The trial will assess a combination of 6% trabodenoson and 0.005% latanoprost, 3% trabodenoson and 0.005% latanoprost, 6% trabodenoson with 0.0025% latanoprost, as well as individual doses of 0.005% latanoprost and 0.0025% latanoprost.
The trabodenoson doses were chosen to optimise IOP decrease and maintain the established tolerability and safety profile, while the selected latanoprost doses were based on efficacy and safety profiles of various doses.
It is expected that the top-line results from the Phase II FDC trial will be reported in July.