Glaucoma Candidate Takes Steps Toward FDA Approval

Because latanoprostene bunod (Vesneo) demonstrated noninferiority to timolol maleate (Timoptic 5%) in pivotal Phase 3 studies, Bausch + Lomb expects to submit a new drug application to the FDA for the glaucoma treatment’s approval in mid-2015.

Previously known as BOL-303259-X and NCX 116, Vesneo is a novel nitric oxide-donating prostaglandin F2-alpha analog that was developed to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, according to Bausch + Lomb parent company, Valeant Pharmaceuticals International Inc.

The drug’s Phase 3 program included 2 separate randomized, multicenter, double-masked, parallel-group clinical studies, APOLLO and LUNAR, which were designed to compare the efficacy and safety of Vesneo to Timoptic 5%. Across a combined total of 840 patients, those treated with Vesneo experienced a reduction in mean IOP of 7.5 to 9.1 mm Hg from baseline between 2 and 12 weeks of treatment—an effect that was statistically superior to Timoptic treatment.

"The results of these studies confirm the results observed in the Phase 2b trials,” noted Robert Weinreb, MD, chairman and professor of Ophthalmology and director at the Hamilton Glaucoma Center at the University of California, San Diego, in the press release. “Vesneo effectively lowered IOP, which is critical in the management of glaucoma or ocular hypertension, and was well-tolerated."

Although there were no significant safety findings in either trial, such data from the studies will be collected for a total of up to 12 months. In the meantime, Bausch + Lomb expects to file for Vesneo’s FDA approval in the first half of 2015 and then launch the drug by the first half of 2016.

"Valeant is committed to innovation in healthcare and continues to fund important research and development programs that will bring benefits to physicians and the patients they serve," stated Valeant Chairman and CEO J. Michael Pearson in a press release. "We are pleased with the Phase 3 program top-line results and look forward to continuing to advance the Vesneo program as part of this commitment.”