Bausch + Lomb announced positive results from the pivotal Phase 3 studies with Vesneo (latanoprostene bunod) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Vesneo is a nitric oxide-donating prostaglandin F2-alpha analog.
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 once daily against timolol maleate 0.5% twice daily in lowering IOP in 840 patients with open-angle glaucoma or ocular hypertension. The primary endpoint of both studies was the reduction in mean IOP measured at specified time points during three months of treatment.
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 7.5–9.1mmHg 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.
Bausch + Lomb plans to submit a New Drug Application (NDA) to the FDA for Vesneo in mid-2015.
For more information call (800) 553-5340 or visit Valeant.com.