VESNEO (latanoprostene bunod)
FDA filing expected mid-2015 following positive top-line efficacy results from pivotal phase 3 studies
VESNEO (latanoprostene bunod) is a nitric oxide-donating prostaglandin F2-alpha analog in phase 3 clinical development for the reduction of intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. It was licensed to Bausch + Lomb by Nicox in March 2010.
In September 2014, Bausch + Lomb and Nicox announced positive top-line results from the pivotal phase 3 studies conducted with VESNEO. These studies met their primary endpoint and showed positive results on a number of secondary endpoints.
The pivotal phase 3 program includes two separate randomized, multicenter, double-masked, parallel-group clinical studies, APOLLO and LUNAR, designed to compare the efficacy and safety of VESNEO administered once daily (QD) against 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 include a combined total of 840 patients, was the reduction in mean IOP measured at specified time points during three months of treatment. The collection of patient safety data for a total of up to 12 months is still ongoing. The phase 3 studies are pivotal for U.S. registration and are being conducted in North America and Europe.
The primary endpoint of non-inferiority to timolol maleate 0.5% was achieved in both Phase 3 studies. Additionally, VESNEO showed a reduction in mean IOP of 7.5 to 9.1 mmHg from baseline between 2 and 12 weeks of treatment in the two phase 3 studies. This IOP effect was statistically superior (p < 0.05) to timolol in both studies. VESNEO also showed positive results on a number of secondary endpoints. There were no significant safety findings in either study.
Bausch + Lomb expects to submit a new drug application to the FDA for the approval of VESNEO in mid-2015 and expect to launch it in the US in the first half of 2016, pending FDA approval.
In July 2013, Bausch + Lomb initiated two additional studies in Japan: JUPITER (Phase 3) and KRONUS (Phase 1). A confirmatory efficacy study is expected to be required for the Japanese registration of latanoprostene bunod.