Phase 3 trial of glaucoma drug underway

Bausch & Lomb has initiated two phase 3 clinical studies of latanoprostene bunod to reduce IOP in patients with glaucoma or ocular hypertension. Licensed by Nicox S.A., the drug candidate is a nitric oxide-donating prostaglandin F2 alpha analog.

Two separate randomized, multi-center, double-masked, parallel-group clinical studies, APOLLO and LUNAR, will compare the efficacy and safety of once-daily latanoprostene bunod with twice-daily timolol maleate 0.5 percent. The studies will include a combined total of approximately 800 patients. Their primary endpoint is reduction in mean IOP during three months of treatment.

Bausch & Lomb's decision to proceed with this program followed positive phase 2 results showing latanoprostene bunod consistently lowered IOP in a dose-dependent manner. All four doses tested in the trial showed greater IOP reduction compared with Xalatan 0.005 percent, with the differences for two of the four doses reaching more than 1 mmHg (P<0.01).