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news.NicOx has reported positive results of a US Phase II study, conducted by its partner Pfizer, which compared the safety and efficacy of various doses of PF-03187207 to Xalatan 0.005% in patients with primary open-angle glaucoma and ocular hypertension.
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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.
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). Michele Garufi, chairman and CEO of NicOx, said: "We believe these results for PF-03187207 suggest nitric oxide donation can bring therapeutic benefit through improved intraocular pressure lowering. Although Pfizer has decided that PF-03187207 does not meet its specific requirements for the US and European markets, we believe this Phase II study demonstrates a clear commercial potential for PF-03187207 and we are exploring possible strategies with Pfizer to unlock this value."