Improved latanoprost drug submitted for FDA approval

Bausch & Lomb has submitted a new drug application for a new class of latanoprost for reducing IOP in patients with glaucoma and ocular hypertension.

Latanoprostene bunod (Vesneo) is a nitric oxide-donating prostaglandin F2-alpha analog, the first nitric-oxide donating agent for ophthalmic use. This combination creates a dual action drug that can both improve uveoscleral outflow and blood flow to the optic nerve.

Two randomized, multicenter, double-masked studies showed that once-daily latanoprostene bunod achieved better IOP control than twice-daily timolol maleate 0.5%.Both studies showed a reduction in mean IOP of 7.5 to 9.1 mmHg from baseline between 2 and 12 weeks of treatment (P< 0.05).

Latanoprostene bunod 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. latanoprost 0.005%, defined as patients achieving an IOP of 18mmHg or less. The responder rate was 68.7% for the most efficacious dose of latanoprostene bunod, compared to 47.5% for latanoprost 0.005% (p=0.006).