SEP 25, 2014
Comprehensive Ophthalmology, Glaucoma
A Bausch & Lomb drug candidate demonstrated in a phase 3 clinical trial non-inferiority to twice-daily timolol maleate in reducing IOP.
Vesneo (latanoprostene bunod) is a nitric oxide-donating prostaglandin F2-alpha analog licensed by Nicox S.A. to Valeant Pharmaceuticals, Inc., subsidiary Bausch & Lomb.
The companies expect to submit a new drug application to the FDA for Vesneo in mid-2015. They project peak sales of around $500 million in the United States and around $1 billion globally.
"The results of these studies confirm the results observed in the phase 2b trials,” said Robert N. Weinreb, MD, chairman & distinguished professor of ophthalmology and director of the Hamilton Glaucoma Center at the University of California, San Diego. “Vesneo effectively lowered IOP, which is critical in the management of glaucoma or ocular hypertension, and was well-tolerated.”
The Phase 3 program includes two randomized, multicenter, double-masked, parallel-group clinical studies, with a combined total of 840 patients, designed to compare the efficacy and safety of Vesneo taken once daily against timolol maleate 0.5% taken twice daily in lowering IOP in patients with open-angle glaucoma or ocular hypertension.
The primary endpoint‑non-inferiority to timolol maleate in reducing mean IOP over three months‑was achieved in both studies. Additionally, Vesneo reduced mean IOP by 7.5 to 9.1 mmHg from baseline between 2 and 12 weeks, which was superior (P < 0.05) to timolol. The collection of patient safety data up to 12 months is ongoing.