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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.
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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.
