Take-home message: Pharmacologic products and devices in development continue to gain momentum in the glaucoma treatment armamentarium.
New glaucoma drugs and new delivery systems for them both inched forward into 2016, bolstering hopes for more effective and less burdensome treatments.
Researchers reported promising phase III results for latanoprostene bunod (Bausch + Lomb) and netarsudil ophthalmic solution (Rhopressa, Aerie Pharmaceuticals).
Both companies ran into manufacturing problems, however, that set back their new drug applications to the FDA.
Meanwhile, ForSight Vision5 reported hopeful phase II data for its topical ring that slowly releases bimatoprost (Helios).
Latanoprostene bunod not only matched but also beat the IOP-lowering effects of timolol in two phase III trials published in 2016. In the most recent one, published July 6 in the American Journal of Ophthalmology (2016;168:250-259), IOP fell at least 25% in 31.0% of patients who received latanoprostene compared with 18.5% of patients who received timolol.
The patients required only once-daily administration of latanoprostene bunod, an advantage for adherence since several other classes of anti-glaucoma drugs require multiple dosing during the day.
Ocular treatment-emergent adverse events, while uncommon, appeared more frequently in the latanoprostene group, but all were mild-moderate except one case of severe hyperemia.
Latanoprostene bunod is metabolized in the eye to latanoprost acid and butanediol mononitrate. An F2α prostaglandin analog, latanoprost acid increases outflow of aqueous fluid primarily through the uveoscleral pathway. Butanediol mononitrate releases nitric oxide, which is reported to induce relaxation of cells in the trabecular meshwork and Schlemm’s canal, increasing outflow through them.
Despite the hopeful findings, Bausch + Lomb’s new drug application for the drug met with rejection from the FDA for manufacturing reasons. The company planned to meet with the regulators to resolve the problem.