Contact lens giant Bausch + Lomb has confirmed it will push forward with phase III of a clinical trial of latanoprostene bunod in the reduction of intraocular pressure (IOP) for patients with glaucoma or ocular hypertension.
Announced in partnership with Nicox, the third phase of the study will include two separate randomised, multi-centre, double-masked clinical studies named Apollo and Lunar. They are both designed to compare the efficacy and safety of the drug when administered once daily, in addition to timolol maleate 0.5% twice daily, in lowering IOP for patients with open-angle glaucoma or ocular hypertension.
Around 800 patients will take part in the studies, which will be performed in North America and Europe.
B+L’s decision to go ahead with phase III of the program follows positive results in the phase IIb trial which tested 413 patients with heightened IOP as a result of the eye conditions. Researchers reported that the drug ‘consistently lowered IOP in a dose-dependent manner.’
Cal Roberts, executive president and chief medical officer at B+L, said: “Bausch + Lomb believes that latanoprostene bunod has the potential to become an important new treatment option for people suffering from elevated IOP due to glaucoma and hypertension.
“We look forward to completing this pivotal research program, and hope to develop an effective new treatment option to benefit physicians and the patients they serve.”
Latanoprostene bunod has been licensed by Nicox to Bausch + Lomb.
Chairman and CEO of Nicox, Michele Garufi, added: “Latanoprostene bunod is a nitric oxide-donating compound which was discovered in our research laboratories in Milan and is the first Nicox program licensed to a partner to enter into phase III.
“We are pleased with B+L’s commitment to pursing this program in an area of significant therapeutic need. The whole Nicox team has contributed to this important milestone which underlines the potential of our research platform in the ophthalmic field.”