Bausch + Lomb, Novaliq submit new drug application for NOV03
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Bausch + Lomb and Novaliq have submitted a new drug application for NOV03 to the FDA for the treatment of signs and symptoms dry eye disease associated with meibomian gland dysfunction, according to a press release.
NOV03 (perfluorohexyloctane) ophthalmic solution has been investigated in the phase 2 SEECASE trial, the phase 3 GOBI trial, the phase 3 MOJAVE trial and the KALAHARI safety extension trial in participants with dry eye disease associated with meibomian gland dysfunction.
“If approved by the FDA, NOV03 will be the first available therapy indicated to address the signs and symptoms for this patient population,” Joseph C. Papa, chairman and CEO, Bausch + Lomb, said in the release. “The NOV03 filing is an example of the commitment of Bausch + Lomb toward bringing novel treatment options to the industry so that we can better serve patients.”
In 2019, Bausch + Lomb acquired an exclusive license to commercialize and develop the preservative-free eye drop in the United States and Canada.
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