March 19, 2012
Bausch and Lomb and NixOx reported results from a phase IIb trial of BOL-303259-X for open-angle glaucoma or ocular hypertension. This trial enrolled 413 subjects who received various concentrations of BOL-303259-X or Xalatan 0.005% ophthalmic solution once daily for 28 days. The primary efficacy endpoint was the reduction in mean diurnal intraocular pressure (IOP) at 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 (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 versus Xalatan 0.005%. 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.
February 18, 2003
The University of Arizona reported positive results from a post-marketing study investigating Lumigan (bimatoprost ophthalmic solution), a synthetic prostamide analog for the treatment of glaucoma. Results showed that the average reduction in eye pressure was greater for subjects treated with Lumigan than with the alternative medication, Xalatan (latanoprost ophthalmic solution). Nearly three times as many subjects failed to respond to Xalatan than to Lumigan at certain measured time points. In addition, subjects treated with Lumigan reached a significantly lower mean intraocular pressure level than subjects in the Xalatan group. Itching was more common in subjects treated with Lumigan, and ocular burning was more common in subjects treated with Xalatan. Eyelash growth and red eye were reported with both medications. The randomized, blinded study enrolled 269 subjects with ocular hypertension and/or glaucoma.