Glaucoma candidate moves to phase III

Sophia Antipolis, France, and Madison, NJ-Bausch + Lomb and NicOx S.A. have announced positive top-line results from a phase IIb study conducted with BOL-303259-X, a nitric oxide-donating prostaglandin F2-alpha analog, in patients with open-angle glaucoma or ocular hypertension.

According to the companies, the phase IIb study met its primary efficacy endpoint-the reduction in mean diurnal IOP on day 28-and showed positive results on several secondary endpoints; BOL-303259-X consistently lowered IOP in a dose-dependent manner; and two of the four doses tested showed greater IOP reduction compared with latanoprost ophthalmic solution 0.005%, with the differences reaching more than 1 mm Hg (p < 0.01).

“We know from several studies that every mm Hg of IOP reduction is important, as it reduces the risk of developing glaucoma and progression of glaucoma,” said Robert N. Weinreb, MD, chairman of ophthalmology at the University of California, San Diego. “A safe and well-tolerated therapy that can better lower IOP compared [with] current prostaglandin [analog] therapies would be welcomed by both clinicians and patients.”

The most efficacious dose of BOL-303259-X also showed positive results on many secondary endpoints, including consistently better control of IOP over 24 hours on day 28, as well as a statistically significant greater percentage of response versus latanoprost, defined as patients achieving an IOP of 18 mm Hg or less, according to the companies. The response rate was 68.7% for the most efficacious dose of BOL 303259 X, compared with 47.5% for latanoprost (p = 0.006).

The safety of BOL-303259-X was comparable with that of latanoprost, according to the companies. The most common adverse event was ocular hyperemia, which occurred at a similar rate across all treatment groups.

Bausch + Lomb initiated the randomized, investigator-masked phase IIb study in November 2010. The study enrolled 413 patients across 23 sites in the United States and Europe. Patients were randomly assigned to receive either BOL 303259 X (various concentrations) or latanoprost once a day in the evening for 28 days.

BOL-303259-X (previously called NCX 116) was licensed by NicOx to Bausch + Lomb in March 2010. In light of these positive results, Bausch + Lomb will pay a $10 million milestone payment to NicOx and will begin a global phase III development program for BOL-303259-X.

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