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Positive Late-Stage Data Reported for Glaucoma Candidate Vesneo (Latanoprostene Bunod)

FDA submission expected in mid-2015

Promising results have been reported from pivotal phase III studies of Vesneo (latanoprostene bunod; Valeant Pharmaceuticals International/Bausch + Lomb/Nicox S.A.) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Vesneo is an investigational nitric oxide-donating prostaglandin F2-alpha analog.

The studies met their primary endpoints and showed positive results on a number of secondary endpoints.

The pivotal phase III program for Vesneod included two randomized, double-masked, parallel-group clinical trials (APOLLO and LUNAR) designed to compare the efficacy and safety of Vesneo administered once daily with that of timolol maleate 0.5% administered twice daily in lowering IOP in 840 patients with open-angle glaucoma or ocular hypertension. The primary endpoint of both studies was the reduction in mean IOP measured at specified time points during 3 months of treatment. The collection of patient safety data for a total of up to 12 months is still ongoing.

The primary endpoint of non-inferiority to timolol maleate 0.5% was achieved in both phase III trials. In addition, Vesneo achieved a reduction in mean IOP of 7.5 to 9.1 mm Hg from baseline between 2 and 12 weeks of treatment in the two studies. This IOP effect was statistically superior (P < 0.05) to that of timolol in both studies. Vesneo also showed positive results on a number of secondary endpoints. There were no significant safety findings in either study.

A new drug application for Vesneo is expected to be submitted to the FDA in mid-2015.

Glaucoma is a group of eye diseases that can lead to the loss of peripheral vision and eventually total blindness. Glaucoma is frequently linked to abnormally high pressure in the eye (IOP) due to blockage or malfunction of the eye’s drainage system. Abnormally high IOP does not cause symptoms itself; however, it can lead to optic nerve damage and vision loss if left untreated.

Drug therapy is used to reduce IOP, thereby preventing further vision loss, typically through increasing the drainage of intraocular fluid by relaxing certain muscles in the eye. Several large trials have demonstrated that reducing IOP can prevent the progression of glaucoma in both early and late stages of the disease. A significant proportion of patients with elevated IOP require more than one medication to maintain their IOP within target levels.

Source: Valeant Pharmaceuticals International; September 25, 2014.

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