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news.Bausch + Lomb, a partner of NicOx, has started a a randomised, single-masked, parallel-group dose- finding Phase 2b clinical study with BOL-303259-X, previously known as NCX 116, a nitric oxide-donating prostaglandin F2-alpha analog, which lowers intraocular pressure through a dual mechanism of action.
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BOL-303259-X has been developed for the potential treatment of glaucoma and ocular hypertension and was licensed to Bausch + Lomb by NicOx in March 2010.
BOL-303259-X Phase 2b study is intended to identify the most effective dose of the drug, administered in the evening, for the reduction of intraocular pressure (IOP).
NicOx said that BOL-303259-X has already completed two Phase 2 studies in patients with glaucoma and ocular hypertension with promising results and the data from these studies indicated that evening administration of BOL-303259-X was more effective than morning administration.
Bausch + Lomb Pharmaceuticals Clinical & Medical Sciences vice president of regulatory affairs Baldo Scassellati Sforzolini said that in the Phase 2b study, which is considerably larger than the previous Phase 2 studies, they would be looking for confirmation of some key differentiating factors observed in earlier studies.
BOL-303259-X’s new Phase 2b study will involve a total of approximately 400 patients with open-angle glaucoma or ocular hypertension.
Reportedly, the primary efficacy endpoint is the reduction in mean diurnal IOP at day 28, while the secondary measures will include the reduction of mean diurnal IOP at other time points and the safety of BOL-303259-X, as compared to Xalatan.