25 September 2014
- Expect to file in the U.S. in First Half of Q2 2015
- Expect to launch in the U.S. in First Half of 2016
- Peak US sales ~$500 million+, Peak Global Sales ~$1 billion+
LAVAL, QUEBEC and SOPHIA ANTIPOLIS, FRANCE
Valeant Pharmaceuticals International, Inc.’s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (NYSE Euronext Paris: COX) today announced positive top-line results from the pivotal Phase 3 studies conducted with VESNEO (latanoprostene bunod; previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. VESNEO is a novel nitric oxide-donating prostaglandin F2-alpha analog licensed by Nicox to Bausch + Lomb. These studies met their primary endpoint and showed positive results on a number of secondary endpoints. This product has peak sales potential of ~$500 million+ in the U.S. alone and ~$1 billion+ globally. These positive results follow three successful approvals from the Food and Drug Administration (FDA) in the last year, including approvals for Luzu® (luliconazole) Cream Jublia® (efinaconazole 10% topical solution) and Retin-A Micro (tretinoin) Gel microsphere 0.08%, and further validate our unique output-driven approach to R&D.
“The results of these studies confirm the results observed in the phase 2b trials. VESNEO effectively lowered IOP, which is critical in the management of glaucoma or ocular hypertension, and was well-tolerated” said Robert N. Weinreb, M.D., chairman & distinguished professor of Ophthalmology and director, Hamilton Glaucoma Center at the University of California San Diego.
“Valeant is committed to innovation in healthcare and continues to fund important R&D programs that will bring benefits to physicians and the patients they serve,” stated J. Michael Pearson, chairman and chief executive officer, Valeant Pharmaceuticals International, Inc. “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. We are proud of our R&D Team who have worked diligently over the past four years to bring this program to successful completion. We are pursuing development plans and programs for other priority markets around the world.”
“VESNEO was discovered in our Research Laboratories in Milan and we are encouraged by these promising results from Bausch + Lomb’s pivotal Phase 3 studies,” said Michele Garufi, chairman and CEO of Nicox. “The success of this program thus far highlights the promise of nitric oxide donation in the treatment of serious ophthalmic conditions and we are delighted by Valeant’s commitment to bringing a new treatment option to patients.”
Phase 3 study design and top-line results
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 administered once daily (QD) against timolol maleate 0.5% administered twice daily (BID) in lowering IOP in patients with open-angle glaucoma or ocular hypertension. The primary endpoint of both studies, which include a combined total of 840 patients, was the reduction in mean IOP measured at specified time points during three months of treatment. The collection of patient safety data for a total of up to 12 months is still ongoing. The Phase 3 studies are pivotal for U.S. registration and are being conducted in North America and Europe. Additional information about the studies can be found at www.clinicaltrials.gov.
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 to 9.1 mmHg 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. VESNEO also showed positive results on a number of secondary endpoints. There were no significant safety findings in either study.
Bausch + Lomb expects to submit a new drug application to the FDA for the approval of VESNEO in mid-2015.