B+L initiates Phase III program for glaucoma drug candidate licensed from Nicox

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) licensed by Nicox S.A. to B+L.

B+L’s drug candidate is intended for the reduction of intraocular pressure (IOP) in patients with elevated IOP due to glaucoma or ocular hypertension. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog.

This pivotal 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 QD with timolol maleate 0.5% administered 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 U.S. registration and will be conducted in North America and Europe.

Additional information about the studies can be found at www.clinicaltrials.gov.