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Bausch + Lomb, Nicox announce positive phase 3 results for Vesneo
Bausch + Lomb, a subsidiary of Valeant, and Nicox announced that pivotal phase 3 studies conducted with Vesneo yielded positive top-line results, according to a joint press release.
Vesneo (latanoprostene bunod; previously known as BOL-303259-X and NCX 116) is a novel nitric oxide-donating prostaglandin F2-alpha analog indicated for the reduction of IOP in patients with glaucoma or ocular hypertension.
The phase 3, randomized, multicenter, double-masked, parallel-group clinical studies, APOLLO and LUNAR, comprised 840 patients with open-angle glaucoma or ocular hypertension.
Researchers investigated the efficacy and safety of latanoprostene bunod administered once daily compared with timolol maleate 0.5% twice daily and found latanoprostene bunod reduced mean IOP 7.5 mm Hg to 9.1 mm Hg from baseline between 2 and 12 weeks of treatment. No significant safety findings were reported in either study, according to the release.
Bausch + Lomb plans to submit a new drug application to the U.S. Food and Drug Administration in mid-2015, according to the release.
In related news, Valeant announced that Jeffrey W. Ubben, founder, CEO and chief investment officer of ValueAct Capital, has been appointed director of the board, effective Oct. 1, 2014.