Valeant Pharmaceuticals International’s wholly owned subsidiary Bausch + Lomb has received approval from the US Food and Drug Administration (FDA) for its new drug application (NDA) for the once-daily glaucoma treatment Vyzulta.
Vyzulta is indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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Valeant Pharmaceuticals International chairman and CEO Joseph Papa said: “With today’s approval of Vyzulta, our customers and their patients with glaucoma now have a new treatment option that can help provide consistent and sustained IOP lowering, the only modifiable risk factor that can help slow down the progression of the disease.
“We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.”
Following topical administration, the once-daily monotherapy with a dual mechanism of action, Vyzulta, works by metabolising into two moieties, latanoprost acid.
Conjunctival hyperemia, eye irritation, eye pain and instillation site pain are the most common ocular adverse events that occur.
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By GlobalDataIn patients with glaucoma, damage to the trabecular meshwork, through which the majority of the aqueous humor passes, can lead to reduced drainage and finally elevated IOP.
Vyzulta was licensed on a global basis to Bausch + Lomb from Nicox, which will receive $17.5m from Bausch + Lomb and will make a $15m payment to Pfizer as part of a previous license agreement.
Nicox chairman and CEO Michele Garufi said: “Vyzulta represents the first FDA-approved therapy developed through our proprietary NO-donating research platform.”
