Pfizer Initiates Study of Treatment for Glaucoma

NicOx announced that Pfizer has initiated the first in a series of planned clinical trials of an experimental treatment for glaucoma. The initiation of this clinical trial follows the FDA's approval of an investigational new drug application for PF-03187207, which triggered a 1 million euro milestone payment from Pfizer to NicOx.

The Phase II, dose-finding study is designed to compare the safety and the efficacy of PF-03187207 with latanoprost. The trial will be a 28-day, parallel-group, randomized and double-blind study, which is expected to enroll approximately 150 patients with primary open angle glaucoma or ocular hypertension in one or both eyes.

The primary endpoint of the study will be the change in diurnal intraocular pressure (IOP) at day 28. Secondary endpoints will include: the change in IOP from baseline at the study center visits on days seven, 14, 21 and 28, the proportion of patients at target IOP across all study visits and safety.

PF-03187207 is the lead development compound generated under the August 2004 collaboration agreement between Pfizer and NicOx, which is focused on R&D of nitric oxide-donating prostaglandin F2-alpha analogs for the treatment of glaucoma. PF-03187207 is expected to have an increased capacity to reduce high IOP based on the well-known activities of nitric oxide. The development of abnormally high IOP, due to blockage or malfunction of systems controlling the amount of fluid in the eye, is believed to be one of the principal causes of glaucoma, according to NicOx.