Bausch + Lomb, the global eye health company, and Nicox S.A. (NYSE Euronext Paris: COX) have announced that Bausch + Lomb has initiated its Phase 3 clinical program of latanoprostene bunod (previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog licensed by Nicox to Bausch + Lomb.
This pivotal Phase III program includes two separate randomised, multicentre, double-masked, parallel-group clinical studies, APOLLO and LUNAR, designed to compare the efficacy and safety of latanoprostene bunod administered once daily (QD) with timolol maleate 0.5% administered twice daily (BID) in lowering IOP in patients with open-angle glaucoma or ocular hypertension. The primary endpoint of both studies, which will include a combined total of approximately 800 patients, is the reduction in mean IOP measured at specified time points during three months of treatment. The Phase III studies are pivotal for US registration and will be conducted in North America and Europe. Additional information about the studies can be found at www.clinicaltrials.gov.
“There is a need for more effective, safer and better tolerated therapies to lower IOP,” said Robert N. Weinreb, MD, chairman & distinguished professor of Ophthalmology, University of California San Diego and director, Shiley Eye Center and Hamilton Glaucoma Center. “The Phase 2b results for latanoprostene bunod were promising, so it is exciting that this potential new therapy is now in pivotal trials.”
Bausch + Lomb’s decision to proceed with a pivotal Phase III program followed positive results with latanoprostene bunod in a Phase 2b trial in 413 patients with elevated IOP due to glaucoma and ocular hypertension. This study showed that latanoprostene bunod consistently lowered IOP in a dose-dependent manner. All four doses tested in the Phase 2b trial showed greater IOP reduction compared with Xalatan® 0.005%, with the differences for two of the four doses reaching more than 1mmHg (statistical significance: p<0.01).
“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 ocular hypertension,” said Cal Roberts, MD executive vice president and chief medical officer, Bausch + Lomb. “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 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,” said Michele Garufi, chairman and CEO of Nicox. “We are pleased with Bausch + Lomb’s commitment to pursuing 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.”