Bausch + Lomb
B+L has completed phase III trials of latanoprostene bunod (LBN), its novel prostaglandin analogue + nitric oxide donating moiety. The compound is metabolized into latanoprost-free acid and nitric oxide. Latanoprost-free acid increases uveoscleral outflow to reduce IOP, while nitric oxide donors have been shown to lead to relaxation of the trabecular meshwork to increase outflow and reduce IOP.
Phase II Voyager dose-ranging studies versus latanoprost in patients with open angle glaucoma or ocular hypertension showed a statistically significant reduction in mean diurnal IOP at both 0.024 and 0.040 percent doses (p ≤ 0.009), said Megan Cavet, PhD, manager of medical affairs. The 0.024% dose had the largest proportion of patients with a mean diurnal IOP of 18 mm Hg or less at all time points during the 28-day study. Ocular treatment-emergent adverse events were mild to moderate in severity and were similar in both LBN and latanoprost patients.
The more recent phase III Apollo trial compared LBN against timolol in a 3-month efficacy study that was followed by a 9-month safety extension. LBN showed both a statistically and a clinically significant improvement in IOP at all time points during the efficacy study. The IOP-lowering effect was maintained out to 1 year during the safety extension.
“We have seen LBN can result in a statistically significant IOP lowering compared to both timolol and latanoprost,” Dr. Cavet said. “LBN also showed 24-hour, IOP control over a range of baseline IOPs and there were no significant treatment-associated adverse events.”