Bausch + Lomb, the global eye health company, and NicOx S.A. (NYSE Euronext Paris: COX) today announced positive top-line results from the phase 2b study conducted with BOL‑303259‑X, a novel nitric oxide-donating prostaglandin F2‑alpha analog, in patients with open-angle glaucoma or ocular hypertension. BOL‑303259‑X (previously NCX 116) was licensed by NicOx to Bausch + Lomb in March 2010 (see NicOx and Bausch + Lomb press release dated March 3, 2010). Bausch + Lomb will pay a $10 million milestone payment to NicOx and will initiate a global phase 3 development program for BOL-303259-X.
The phase 2b study met its primary efficacy endpoint and showed positive results on a number of secondary endpoints. The primary efficacy endpoint was the reduction in mean diurnal intraocular pressure (IOP) on day 28. BOL‑303259‑X consistently lowered IOP in a dose-dependent manner. Two of the four doses tested showed greater IOP reduction compared with Xalatan® 0.005%, with the differences reaching more than 1mmHg (statistical significance: p<0.01).
"We know from several studies that every mmHg of IOP reduction is important, as it reduces the risk of developing glaucoma and progression of glaucoma," said Robert N. Weinreb, M.D., Distinguished Professor and Chairman of Ophthalmology, University of California San Diego. "A safe and well-tolerated therapy that can better lower IOP compared to current prostaglandin therapies would be welcomed by both clinicians and patients."
The most efficacious dose of BOL‑303259‑X also showed positive results on a number of secondary endpoints, including consistently better control of IOP over 24 hours on day 28 as well as a statistically significant greater percentage of responders vs. Xalatan® 0.005%, defined as patients achieving an IOP of 18mmHg or less. The responder rate was 68.7% for the most efficacious dose of BOL‑303259‑X, compared to 47.5% for Xalatan® 0.005%.
The safety of BOL‑303259‑X was comparable to Xalatan®. The most common adverse event was ocular hyperemia (red eye), which occurred at a similar rate across all treatment groups.
Bausch + Lomb initiated the randomized, investigator-masked phase 2b study in November 2010 to identify the most efficacious and safe dose of BOL‑303259‑X for the reduction of IOP. The study enrolled 413 patients across 23 sites in the United States and Europe. Patients were randomized to receive either BOL‑303259‑X (various concentrations) or Xalatan® 0.005% (latanoprost) once a day in the evening for 28 days.
"Bausch + Lomb is committed to funding and developing innovative new medicines to benefit physicians and the patients they serve," said Dan Wechsler, Executive Vice President and President, Global Pharmaceuticals, Bausch + Lomb. "BOL‑303259‑X adds to our growing portfolio of potential new products in eye health. We are encouraged by the positive results of our phase 2b study and hope that through further research and development, BOL‑303259‑X will provide a promising new treatment option for the millions of people around the world suffering from elevated IOP due to glaucoma or ocular hypertension."
Michele Garufi, Chairman and CEO of NicOx, said, "These positive results support the strong potential of our nitric oxide-donating platform in the ophthalmology field and we look forward to continuing to collaborate with the Bausch + Lomb team on the phase 3 development program."
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