Bausch + Lomb and Nicox announced that the FDA has set a deadline of August 24, 2017 for its decision on the new drug application for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an IOP-lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension.
If approved, latanoprostene bunod would be the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.
"This is an exciting development in our journey to bring this new treatment option to the more than 3 million patients in the U.S. with open angle glaucoma and ocular hypertension, and address a significant unmet medical need," Joseph C. Papa, Chairman and CEO of Valeant, said in a company news release. "Valeant is committed to delivering therapies that make a difference in patients' lives, and our work on latanoprostene bunod is a strong example of that."
"If granted, the FDA's approval of latanoprostene bunod will allow for the introduction of the first truly novel medication for these patients in many years," said Michele Garufi, Chairman and CEO of Nicox. "Additionally, latanoprostene bunod would represent the first commercially available therapy to use our proprietary nitric oxide-donating R&D platform, which we will continue to apply in the development of future innovative ophthalmic compounds."
Latanoprostene bunod was licensed by Nicox to Bausch + Lomb.
On July 21, 2016, Bausch + Lomb announced its receipt of a complete response letter from the FDA regarding the latanoprostene bunod. The CRL cited concerns pertaining to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida. The FDA's letter did not identify any efficacy or safety concerns with respect to the latanoprostene bunod NDA or additional clinical trials needed for the approval of the NDA.