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Bausch + Lomb begins phase 3 studies of glaucoma drug candidate

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Bausch + Lomb has begun a pair of phase 3 clinical studies on latanoprostene bunod to reduce IOP in patients with glaucoma or ocular hypertension, according to a company news release.

The drug candidate, licensed from Nicox and previously known as BOL-303259-X and NCX 116, is a nitric oxide-donating prostaglandin F2 alpha analog. The APOLLO and LUNAR studies are two separate randomized, multicenter, double-masked, parallel-group clinical studies that will be conducted in North America and Europe.

The studies will examine the safety and efficacy of the drug candidate administered once daily compared with timolol maleate 0.5% administered twice daily, according to the release. About 800 subjects will be enrolled and analyzed for reduction in mean IOP during 3 months of treatment.

Bausch + Lomb initially signed a $10 million global licensing agreement with Nicox for latanoprostene bunod in 2010 and made an additional $10 million milestone payment in 2012 following positive results of a phase 2b trial involving 413 patients.

The agreement could net as much as $162.5 million for Nicox, along with royalties, if regulatory, commercialization and sales milestones are met, the release said.