New Glaucoma Treatment on Track for FDA Approval

The FDA is reviewing a novel treatment for patients with open angle glaucoma or ocular hypertension.

Bausch and Lomb and Nicox’s latanoprostene bunod ophthalmic solution 0.024% (Vesneo) is a single-agent eye drop dosed once a day and designed to lower intraocular pressure (IOP).

If approved, Vesneo will become the first nitric oxide-donating prostaglandin receptor agonist for open angle glaucoma and ocular hypertension, both of which have “significant unmet medical needs,” according to Nicox chairman and CEO Michele Garufi.

"If granted, the FDA's approval of Vesneo will clear the way for the first truly novel IOP-lowering medication in years," Garufi said.

The FDA is expected to complete its review of the eye drop on July 21, 2016.

When latanoprostene bunod is instilled in the eye, the ophthalmic solution rapidly metabolizes to 2 actives: latanoprost acid and nitric oxide, the latter of which plays a key role in regulating IOP in healthy eyes.

Vesneo is believed to increase aqueous humor outflow by acting on the uveoscleral pathway through latanoprost acid, and the trabecular meshwork and Schlemm's canal through nitric oxide signaling. This can lower IOP and prevent further vision loss.

Several large clinical trials have demonstrated that reducing IOP can prevent glaucoma progression in both early and late disease stages.

Glaucoma is linked to abnormally high pressure in the eye, which usually does not cause symptoms, but can eventually lead to optic nerve damage and vision loss over time if left untreated.