Date: 2012-03-13
Type of information:
phase: 2b
Announcement: results
Company: NicOx (France) Bausch&Lomb (USA)
Product: BOL-303259-X
Action mechanism: BOL-303259-X (previously NCX 116) is a nitric oxide-donating prostaglandin F2-alpha analog.
Disease: open-angle glaucoma
ocular hypertension
Therapeutic area: Ophtalmological diseases
Country: USA, Europe
Trial
details: 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.
Latest
news: Bausch&Lomb and NicOx have announced positive top-line results from the phase 2b study conducted with BOL-303259-X, in patients with open-angle glaucoma or ocular hypertension. 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).
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% (p=0.006).
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.
In March 2010, NicOx and Bausch&Lomb signed a worldwide licensing agreement for BOL-303259-X for the potential treatment of glaucoma and ocular hypertension. Under the terms of the agreement, Bausch&Lomb made an initial license payment to NicOx of $10 million. In light of these positive results, Bausch&Lomb will pay an additional $10 million milestone payment to NicOx and will initiate a global phase 3 development program for BOL-303259-X.
NicOx stands to receive potential regulatory, commercialization and sales success-based milestones, which could total an additional $162.5 million. NicOx will also receive tiered double-digit royalties on the sales of BOL- 303259-X. NicOx has the option to co-promote BOL-303259-X products in the United States.
