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news.NicOx has reported that Pfizer has initiated a dose-ranging Phase II clinical study for PF-03187207 in Japan, which will compare the safety and efficacy of PF-03187207 to Xalatan in Japanese patients with glaucoma and ocular hypertension.
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The new Japanese trial is a 28 day, double-masked, dose-ranging study, in which approximately 120 Japanese patients with primary open-angle glaucoma or ocular hypertension, in one or both eyes, will be randomized to treatment groups that will receive different doses of PF-03187207 or Xalatan.
The objective of the study is to investigate the dose response, safety and efficacy of PF-03187207 in this patient population. The primary endpoint is the reduction in IOP at day 28, compared to baseline. Secondary endpoints will include safety assessments and the IOP on days 14 and 28, as well as the proportion of patients attaining target IOP or less at each of the study visits.
PF-03187207 is a new experimental medicine for the treatment of glaucoma, which is currently in an ongoing Phase II proof-of-concept study in the US.
Maarten Beekman, vice president of clinical development at NicOx, said: “We believe the initiation of this separate Japanese study for PF-03187207 highlights Pfizer’s determination to rapidly advance this clinical program towards coordinated regulatory filing in the world’s major pharmaceutical markets.”