Twelve-month safety results and efficacy levels were reported recently for the Mercury 1 phase III registration trial for a fixed-dose combination of netarsudil ophthalmic solution 0.02% and latanoprost 0.005% (Roclatan, Aerie Pharmaceuticals).
Mercury 1, a 12-month safety and efficacy trial, included a 90-day efficacy endpoint and was created to gather sufficient safety data to submit a new drug application (NDA) to the FDA in early 2018, according to a prepared statement from the company.
Mercury 2 is a 90-day efficacy trial and had results reported in May. A third trial called Mercury 3 will be performed in Europe in the third quarter of 2017.
The drug combines netarsudil (Rhopressa, Aerie Pharmaceuticals) with the prostaglandin latanoprost. The product is intended for once-daily use.
Both the Mercury 1 and 2 trials met their 90-day primary efficacy endpoints that demonstrate statistical superiority over each of its individual components at all measured time points. The study also measured IOP at 8 a.m., 10 a.m., and 4 p.m. at 6, 9, and 12 months. Patients included in both trials had maximum baseline IOPs ranging from above 20 mm Hg to 36 mm Hg.
If approved, the agent would be the first glaucoma product to lower IOP through all possible mechanisms, including the increase of fluid outflow through the trabecular meshwork, the increase of fluid outflow through the trabecular meshwork, the reduction of fluid production in the eye, and the reduction of episcleral venous pressure, the company noted.
“By covering the full spectrum of known IOP-lowering mechanisms, [the drug] has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product,” according to a press release from the company.
If approved by the FDA, the product could be a welcome addition to the glaucoma armamentarium, said Robert Fechtner, MD, professor and chairman of ophthalmology, State University of New York, Upstate Medical University, Syracuse, New York.
“Rock inhibitors have been a long time coming,” he said. “With any new class of medications, we always hope to learn as much as we can about what to expect before we start using it in our patients.”
One positive factor from the recent data is that there are 12-month results versus results for only 3 to 6 months, Dr. Fechtner said.
“This is the first prostaglandin fixed-combination that appears to demonstrate superiority to latanoprost alone at all time points,” he said. “The prostaglandin beta-blocker fixed-combinations available elsewhere in the world did not get approval in the United States. We are still waiting for a prostaglandin fixed combination.”
If or when the agent becomes available, it would give an additional once-daily, single-bottle option besides prostaglandin alone to offer patients, Dr. Fechtner said.