Date: 2014-09-25
Type of information: Results
phase: 3
Announcement: results
Company: NicOx (France) Bausch&Lomb (USA)
Product: Vesneo® (latanoprostene bunod (previously known as BOL-303259-X and NCX 116) )
Action
mechanism: Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog.
Disease: reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension
Therapeutic area: Ophtalmological diseases
Country: North America, Europe
Trial
details: This pivotal Phase 3 program includes two separate randomized, 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.
Latest
news: * On September 25, 2014, Valeant Pharmaceuticals International, wholly owned subsidiary, Bausch + Lomb, and Nicox announced positive top-line results from the pivotal Phase 3 studies conducted with Vesneo® (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. These studies met their primary endpoint and showed positive results on a number of secondary endpoints. 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 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. * On January 29, 2013, Bausch + Lomb, the global eye health company, and Nicox 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. These Phase 3 studies are pivotal for U.S. registration and will be conducted in North America and Europe. Bausch + Lomb’s decision to proceed with a pivotal Phase 3 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).
Latanoprostene bunod is a nitric oxide-donating compound which was discovered in Nicox Laboratories in Milan and is the first Nicox program licensed to a partner to enter into Phase 3.
In March 2010, Bausch + Lomb signed a worldwide licensing agreement with Nicox for latanoprostene bunod, and made an initial license payment of $10 million. In light of the positive results of the Phase 2b study completed in 2011, Bausch + Lomb made an additional $10 million milestone payment in April 2012 following their decision to pursue further development of latanoprostene bunod. If certain regulatory, commercialization and sales milestones for latanoprostene bunod are met, Nicox stands to receive from Bausch + Lomb additional potential payments which, over time, could total $162.5 million. Nicox will also receive tiered double-digit royalties on the sales of latanoprostene bunod and has the option to co-promote the product in the United States.
