Bausch + Lomb
Bausch and Lomb (B + L) is taking a different route to a dual-MOA product. Latanoprostene bunod (Vyzulta) breaks down into latanoprost acid, the active ingredient in latanoprost, and butanediol mononitrate, which releases nitric oxide.
“Latanoprostene bunod (LBN) is the first nitric-oxide donating prostaglandin F2α analogue for ophthalmic use,” said Jason L. Vittitow, PhD, senior director for clinical affairs. “We have latanoprost acid, which targets to uveoscleral outflow, and nitric oxide, which increases outflow through the TM.”
Nitric oxide is an endogenous signaling molecule which regulates cellular relaxation and contractility. In glaucoma, the TM is contracted, which impedes aqueous outflow. Nitric oxide acts to relax and expand the TM, enhancing outflow, Vittitow added.
In phase III studies with patients who had a baseline IOP of about 26 mm Hg, once-daily LBN outperformed twice-daily timolol. IOP lowering was maintained over the course of the 12-month trial. About 90% of patients in the LBN arm had 25% or greater lowering of IOP and about 60% had 35% or greater IOP lowering.
That compares to 44% in the timolol arm, a differential of about 60% in favor of LBN, Vittitow said.
“There were no drug-related adverse events (AE) and the most common, non-ocular AE was headache,” Vittitow reported. “About 45% of patients on LBN had hyperemia that was noted at the slit lamp, compared to a baseline of 32%, and 80% were characterized as mild.”