Bausch + Lomb And Nicox Resubmit FDA New Drug Application For Glaucoma Candidate Latanoprostene Bunod
Source: Bausch + Lomb
Bausch + Lomb and Nicox announced the resubmission of a new drug application (NDA) to the FDA seeking approval 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.
The data submitted in the NDA support latanoprostene bunod as the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use. 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.
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