Aerie Pharmaceuticals announced positive topline results for its fixed-dose drug product candidate, Roclatan, a combination of latanoprost and Aerie’s not yet approved IOP drug netarsudil (Rhopressa).
Aerie recently filed a new drug application for once-daily netarsudil as an adjunct therapy to prostaglandin analogues after trials demonstrated it was as effective as a twice-daily beta blocker timolol.
In Roclatan's study, the drug outperformed both netarsudil and latanoprost monotherapy in reducing IOP. The study showed that Roclatan's efficacy was 1 to 3 mmHg greater than either latanoprost or netarsudil. The data was gathered from the first 90 days of Aerie's 12-month phase 3 safety trial called Mercury 1.
"Once-daily Roclatan has shown a degree of IOP lowering in Mercury 1 that is quite impressive, especially when considering its ability to bring patient pressures down to levels as low as 8 to 14 mmHg," said Aerie's chief medical officer, Richard A. Lewis, MD. "The safety profile of Roclatan observed thus far in Mercury 1 points to a safe and tolerable product."
Mercury 1 enrolled patients with maximum baseline IOP greater than 20 and less than 36 mmHg. Eye redness was the most common adverse event, noted in approximately 50% of patients, although most cases were scored as mild.
The study reached its primary efficacy endpoint of demonstrating statistical superiority of the combination treatment over each individual component, netarsudil 0.02% and latanoprost 0.005%.
Subjects dosed with Roclatan showed an IOP-lowering effect 1-3 mmHg greater than those in both individual drug arms at all 9 measurement points across the 90-day period. Additionally, the mean diurnal IOP was reduced to 16 mmHg or lower in 61% of Roclatan patients, which was significantly more than in the netarsudil or latanoprost-only groups.
According to chairman and CEO Vicente Anido, Jr., Ph.D, if Mercury 1 and Aerie's second registration trial, Mercury 2, continue in this positive trajectory, the company will file the NDA for Roclatan in late 2017.