Bausch + Lomb/Valeant,+ Nicox S.A. announced the resubmission of a New Drug Application (NDA) to the FDA for latanoprostene bunod ophthalmic solution to treat open angle glaucoma or ocular hypertension.
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced the resubmission of a New Drug Application (NDA) to the FDA seeking approval for latanoprostene bunod ophthalmic solution, 0.024% (Vesneo). Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT). The data submitted in the NDA support latanoprostene bunod as the first nitric-oxide donating prostaglandin F2 alpha analog for ophthalmic use.
Comment:Vesneo could face competition not only from the generic treatments already on the market as well as from Lucentis (ranibizumab) from Novartis which is in development for glaucoma.