NDA Re-Submitted for Novel Glaucoma Drug

A Complete Response Letter from the FDA last summer had raised concerns about the manufacturing facility
A Complete Response Letter from the FDA last summer had raised concerns about the manufacturing facility

Valeant announced that they have re-submitted the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure (IOP) lowering single-agent eye drop for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Latanoprostene bunod is metabolized to two moieties; latanoprost acid, an F2α prostaglandin analog, and butanediol mononitrate, which releases nitric oxide activating the soluble guanylate cyclase-guanosine-3',5'-monophosphate signaling pathway. It is believed to lower IOP by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. 

Related Articles

In a press release, Valeant stated that the NDA includes data supporting latanoprostene bunod as the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.

Valeant received a Complete Response Letter from the Food and Drug Administration (FDA) last July, in which concerns were raised after an inspection at Bausch + Lomb's (a Valeant company) manufacturing facility, where some deficiencies were identified.

For more information visit Valeant.com.