On the horizon
Aerie has also announced plans to file an NDA for a combination of netarsudil and latanoprost 0.02%/0.005% in the second quarter of 2018.
Also on the horizon is latanoprost in a new formulation using swollen nanocellular microemulsion, Dr. Novack said.
As for the others, “some have full papers out, some abstracts, some we don’t know but we can assume they all tried to meet the minimum that the FDA requires,” he said.
That minimum standard is 3 months’ efficacy at least as good as a marketed product, usually timolol or latanoprost, and superiority to vehicle, Dr. Novack said. The drug also has to have been administered to at least 300 patients—100 of them for at least 12 months.
FDA approval is not the only criterion for making drugs available. They must also be adopted by ophthalmologists and find their way into insurance companies’ formularies, he noted.
“Also in the United States, the FDA is explicitly prohibited from considering pricing, but that’s not true in Europe and Japan,” he added. “So we will see, as these products are developed there, what happens.”
Turning next to phase III drugs as of May 2017, Dr. Novack mentioned trabodenson, a selective adenosine A1 receptor agonist that increases the expression, secretion, and activation of several matrix metalloproteinases (MMPs). These MMPs remodel the extracellular matrix of the trabecular meshwork and restore its mechanosensitivity to increase aqueous outflow and lower IOP.
Trabodenoson failed the primary endpoint of the first phase III trial in ocular hypertension and primary open-angle glaucoma, MATrX-1. The drug’s maker, Inotek Pharmaceuticals (which recently merged with Rocket Pharmaceuticals), has separately explored a combination of trabodenoson and latanoprost in a phase II trial.