Sophia Antipolis, France and Madison, NJ—Bausch + Lomb (B+L) has initiated its phase III clinical program of latanoprostene bunod (previously known as BOL-303259-X and NCX 116) for the reduction of IOP in patients with glaucoma or ocular hypertension. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog licensed by Nicox S.A. to B+L.
The phase III program includes two separate randomized, multicenter, double-masked, parallel-group clinical studies, APOLLO and LUNAR, designed to compare the efficacy and safety of latanoprostene bunod administered once daily with timolol maleate 0.5% administered twice daily in lowering IOP in patients with open-angle glaucoma or ocular hypertension. The phase III studies are pivotal for U.S. registration and will be conducted in North America and Europe. Additional information about the studies can be found at www.clinicaltrials.gov.
"B+L 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, B+L. "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."
"We are pleased with B+L’s commitment to pursuing this program in an area of significant therapeutic need,” said Michele Garufi, chairman and chief executive officer of Nicox. “The whole Nicox team has contributed to this important milestone which underlines the potential of our research platform in the ophthalmic field."
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