The pharma drought is coming to a close. After decades of same-old medications for glaucoma and ocular surface disease, a series of new agents with new mechanisms of action (MOA) are moving toward marketing approval.
“The population is aging and the prevalence of glaucoma in America alone will probably more than double over the next 30 years,” said David A. Hollander, MD, MBA, chief medical officer, Ora, an ophthalmic contract research organization in Hanover, MA. “We still have essentially the same five classes of ophthalmic intraocular pressure (IOP)-lowering medications we have had for decades. It is time for some additions to the armamentarium for treating out patients.”
Hollander moderated an overview of “New Horizons in Pharmaceuticals” as part of the New Horizons Forum at the 2017 Glaucoma 360 meeting. The session highlighted four companies with strong drug candidates for glaucoma and ocular surface disease.
Aerie has two new glaucoma products with multiple new MOA in phase III trials. If approved, they will be the first new MOA in the glaucoma market for more than 20 years.
“Rhopressa (netarsudil) is a single agent that lowers IOP through three different mechanisms,” said Tom Mitro, president and COO. “Rhopressa is a Rho kinase inhibitor, so it restores outflow through the trabecular meshwork (TM). Secondly, it is a norepinephrine transport inhibitor, so it reduces aqueous production. Finally, it lowers episcleral venous pressure. We expect to have Rhopressa approved and on the market about a year from now.”
The drug also offers two efficacy advantages over current IOP-lowering agents, Mitro pointed out. It is dosed once daily versus twice daily and lowers IOP as effectively at night as it does during the daytime. The drug showed no drug-related adverse events during clinical trials and no serious systemic adverse events.
Roclatan is a once-daily, fixed-dose combination of netarsudil and latanoprost. The combination is more effective at lowering IOP than either of its components, Mitro said. More than 40% of patients achieved an IOP of 15 mm Hg or less and nearly 33% of patients dropped to 14 mm Hg or less with no significant adverse events.
“We were delighted with how well Roclatan performed, but not surprised,” Mitro said. “We will unveil a second phase III trial around midyear and initiate phase III trials in Europe and hope to file an (FDA) NDA in late 2017 or early 2018.”