French biotechnology firm NicOx says the results of a dose-ranging Phase II study conducted with PF-03187207 in Japanese patients with glaucoma by its partner, global drugs giant Pfizer, were positive. PF-03187207 is a nitric oxide-donating prostaglandin analog. The study was designed to compare the safety and efficacy of several doses of PF-03187207 to Xalatan (latanoprost) and enrolled 112 Japanese patients with primary open-angle glaucoma or ocular hypertension.
In terms of the reduction in diurnal intraocular pressure, compared to baseline, the two highest doses of PF-03187207 showed an improvement over Xalatan 0.005% of up to 11%, although the study did not meet its primary endpoint at day 28. The drug appeared to be safe and well tolerated, with adverse events being mild.
Following the results of the US study, Pfizer decided not to launch a Phase III program for PF-03187207 outside Asia (Marketletter May 12). After reviewing the findings of this Japanese study, Pfizer has decided not to launch an Asian Phase III program for this compound. The two companies are currently in discussions regarding the rights to PF-03187207, to allow its potential continued development and commercialization, which is covered by their August 2004 agreement.
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