November 1, 2012 – Lexington, MA: Inotek Pharmaceuticals Corp., a leader in the development of innovative drug candidates to address significant diseases of the eye, today announced that final data from a Phase 2 clinical trial of trabodenoson, also known as INO-8875, in patients with primary open-angle glaucoma or ocular hypertension will be presented at the Ophthalmology Innovation Summit on Thursday, November 8, 2012 at the Chicago Marriott Downtown Magnificent Mile in Chicago, IL. The data will be presented by Paul G. Howes, President and Chief Executive Officer of Inotek.
The recently completed Phase 2 trial was a multi-center, randomized, double-masked, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trabodenoson delivered as an eye-drop formulation in patients with primary open-angle glaucoma or ocular hypertension. The trial enrolled 144 patients with IOP greater than or equal to 24 mmHg.
About Trabodenoson for Glaucoma
Glaucoma is a leading cause of blindness globally, and it is broadly accepted that lowering intraocular pressure (IOP) in patients with glaucoma is the only clinically reliable means of slowing the progression of vision loss. Current products for glaucoma, such as beta blockers and prostaglandins, lower IOP by reducing the flow of fluid into the eye or increasing its drainage through a secondary pathway in the eye – the uveoscleral pathway. However, as glaucoma advances with age, outflow through the eye’s trabecular meshwork becomes increasingly difficult as drainage channels narrow, and it is more difficult to lower pressure and slow vision loss only by increasing uveoscleral outflow. As a result, many patients do not respond adequately to the currently approved products, and up to 40% of patients are treated with a combination of products in the hope of achieving targeted reductions in IOP. There remains an unmet need for innovative glaucoma products acting on the trabecular meshwork to provide improved IOP-lowering efficacy.
Trabodenoson has significant potential as an IOP-lowering medicine, either as monotherapy or in combination with other glaucoma products, because it restores the outflow of aqueous humor through the trabecular meshwork. As validation of its complementary mechanism to other glaucoma products, trabodenoson has shown substantial additivity of IOP-lowering efficacy when combined with the leading glaucoma medicine (latanoprost) in a preclinical model. As a highly selective adenosine-1 receptor agonist, trabodenoson has a novel mechanism differentiating it from currently approved products and other candidates in development for glaucoma in that it enhances an innate cellular signaling pathway to improve outflow through the trabecular meshwork.