The trial is a 28-day, double-masked study, in which around 120 Japanese patients with primary open-angle glaucoma or ocular hypertension will be randomised to treatment groups that will receive different doses of PF-03187207 or XalatanÒ. The objective is to investigate the dose response, safety and efficacy of PF-03187207 in this patient population. The primary endpoint is the reduction in intraocular pressure (IOP) at day 28, compared with baseline. Secondary endpoints will include safety assessments and the IOP on days 14 and 28, as well as the proportion of patients attaining target IOP or less at each of the study visits.
PF-03187207 is already the subject of a Phase II proof-of-concept study initiated in March 2007 in the US. This trial also aims to compare the safety and efficacy of PF-03187207 to XalatanÒ in terms of lowering IOP.
The 2004 agreement between NicOx and Pfizer focuses on the research and development of nitric oxide-donating prostaglandin F2-alpha analogues for the treatment of glaucoma. NicOx is researching nitric oxide-donating drugs in the areas of inflammation and cardiometabolic disease. Its two lead compounds are: naproxcinod, which is currently in Phase III development for the treatment of osteoarthritis;
