NicOx announces U.S. phase 2a results for PF-03187207 and gives an update on continuing NO-prostaglandin program
NicOx S.A. announced the results of a U.S. phase 2 study, conducted by its partner Pfizer Inc, which compared the safety and efficacy of various doses of PF-03187207 to Xalatan® (latanoprost) 0.005% in patients with primary open-angle glaucoma and ocular hypertension. The higher doses of PF-03187207 demonstrated a clinically significant reduction in diurnal intraocular pressure (IOP) from baseline and the highest dose showed consistently more IOP lowering than Xalatan® 0.005%, at all study visits and at all individual time points, suggesting a beneficial effect of nitric oxide donation. PF-03187207 is a nitric oxide-donating prostaglandin analog, which is covered by the companies' August 2004 agreement.
On the primary endpoint at 28 days, PF-03187207 showed a 12% improvement over Xalatan® 0.005% which did not reach statistical significance. However, a statistically significant advantage over Xalatan® 0.005% was observed on a number of secondary endpoints (p<0.05).
Pfizer has taken the decision not to launch a global phase 3 development program for PF-03187207. Nevertheless, Pfizer has reaffirmed its commitment to the ongoing joint research program with NicOx, which aims to identify the most active nitric oxide-donating prostaglandin analogs for development on a global basis.
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