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NicOx Announces U.S. Phase 2a Results for PF-03187207 and Gives an Update on Continuing NO-prostaglandin Program
Date:5/6/2008

nal 1 mmHg reduction in IOP observed on the primary endpoint is comparable with that obtained by combining existing drugs with different mechanisms of action and a pivotal phase 3 study could be realistically powered to demonstrate a benefit of this magnitude."

Additional secondary endpoints were the reductions in diurnal IOP from baseline on days 7, 14 and 21, as well as the reductions from baseline at 8am, 10am, 1pm and 4pm, as an average across all study visits. Morning administration of the highest PF-03187207 dose demonstrated a statistically significant advantage compared to morning dosing of Xalatan(R) 0.005% on a number of these secondary endpoints, with the difference in IOP lowering ranging from 25% to 35%, which was approximately 1 mmHg to 2 mmHg in absolute terms (p<0.05).

There were no serious adverse events in any of the PF-03187207 and Xalatan(R) arms and most of the treatment emergent adverse events were mild or moderate. No severe conjunctival hyperemia (redness) was observed in the study, although mean hyperemia scores were higher in the PF-03187207 treated groups.

NOTE: Glaucoma is the leading cause of blindness in the United States and Japan. Pfizer's latanoprost (Xalatan(R) and Xalacom(R)) is the world's leading treatment for the disease, with approximately $1.6 billion of franchise sales globally in 2007 (IMS reports sales of Xalatan(R) in Japan of approximately $250 million in 2007).

Glaucoma is frequently associated with an abnormal build-up of fluid within the eye, which results in raised intraocular pressure (IOP) that can lead to optic nerve damage and vision loss if left untreated. Several large government trials (such as the Ocular Hypertension Treatment Study, the Collaborative Initial Glaucoma Treatment Study and the Advanced Glaucoma Intervention Study) have demonstrated that reducing IOP can prevent the progression of glaucoma in both early and late stages of the disease. A significant proportion of patien
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SOURCE NicOx S.A.
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