Pfizer unveils more details on glaucoma trial collaboration

Sophia Antipolis, France-Biopharmaceutical company NicOx S.A., in a collaborative arrangement with Pfizer Inc., is reporting that Pfizer has released new information pertaining to the first clinical study in a series for PF-03187207 in patients with glaucoma and ocular hypertension. Pursuit of the trial comes as the FDA recently issued an investigational new drug approval for PF-03187207.

The trial is a phase II, dose-finding study that will compare safety and efficacy of PF-03187207 with latanoprost (Xalatan, Pfizer Ophthalmics).

The trial will last 28 days and will be a parallel group, randomized, and double-masked study intending to enroll approximately 150 patients with primary open-angle glaucoma or ocular hypertension, in one or both eyes.

The primary endpoint will be the change in diurnal IOP at day 28. Secondary endpoints will include change in IOP from baseline at follow-up visits on day 7, 14, 21, and 28; the proportion of patients at target IOP across all visits; and safety evaluations.

PF-03187207 is the development compound created through the August 2004 collaboration between the two companies; the collaboration emphasizes research and development of nitric oxide-donating prostaglandin F2-alpha analogs for glaucoma treatment. The compound may enhance ability to lower high IOP within the eye.