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IOP-lowering treatment has promising results in phase 2b study

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SOPHIA ANTIPOLIS, France — A randomized phase 2b study of various doses of a novel nitric oxide-donating prostaglandin F2 alpha analogue demonstrated positive results in reducing IOP, Bausch + Lomb and NicOx announced in a press release.

The investigator-masked study enrolled 413 open-angle glaucoma or ocular hypertension patients at 23 sites in the United States and Europe to determine the most effective and safest dosage of BOL-303259-X, the release said. Patients received a dosage of BOL-303259-X or Xalatan (latanoprost 0.005%, Pfizer) once per day in the evening for 28 days.

The primary endpoint of the study, a reduction in mean diurnal IOP on day 28, was met, according to the release. IOP consistently was lowered in a dose-dependent manner, and two of the four doses showed greater IOP reduction than latanoprost.

"BOL-303259-X adds to our growing portfolio of potential new products in eye health," Dan Wechsler, executive vice president and president, Global Pharmaceuticals, Bausch + Lomb, said in the release. "We are encouraged by the positive results of our phase 2b study and hope that through further research and development, BOL-303259-X will provide a promising new treatment option for the millions of people around the world suffering from elevated IOP due to glaucoma or ocular hypertension."

Based on these results, Bausch + Lomb will make a $10 million milestone payment to NicOx and begin a global phase 3 development program, the release said.