Aerie Pharmaceuticals reported the successful 12-month safety results of the company’s “Mercury 1” phase 3 registration trial for its fixed-dose combination product candidate, Roclatan. Mercury 1 is a 12-month safety and efficacy trial which included a 90-day efficacy endpoint. As previously reported, both Mercury 1 and Mercury 2, the company’s second phase 3 registration trial of Roclatan, achieved their 90-day primary efficacy endpoints of demonstrating statistical superiority over each of its components at all measured time points, including Aerie product candidate Rhopressa (netarsudil ophthalmic solution) 0.02%, and market-leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening.
The purpose of the 12-month Mercury 1 study is to provide adequate safety data for an expected new drug application (NDA) submission to the FDA in the first half of 2018. While not primary endpoints, the study also included measurements of IOP at 8 am, 10 am, and 4 pm at months 6, 9, and 12. The 12-month safety and efficacy results of Mercury 1 were consistent with the 90-day results from the Mercury 1 and Mercury 2 trials, each of which evaluated patients with maximum baseline IOPs ranging from above 20 to below 36 mmHg.
Roclatan 12-Month Safety and Efficacy Highlights for Mercury 1
- Safety results for Roclatan for the 12-month period were consistent with those observed for the 90-day efficacy period in the trial. There were no new adverse events that developed following the initial 90-day period, and there were no drug-related serious or systemic adverse events.
- As expected, the most common adverse event for Roclatan was conjunctival hyperemia, or eye redness, which was observed in approximately 60 percent of patients, of which approximately 70 percent was determined to be mild by biomicroscopy. As observed in previous trials, hyperemia was sporadic, with only approximately 10 percent of patients with hyperemia across each physician visit during the 12-month period.
- The other Roclatan adverse events observed during the 12-month trial are consistent with those observed during the initial 90-day efficacy period, including conjunctival hemorrhages (subconjunctival petechiae) and cornea verticillata.
- In addition to the primary efficacy endpoint at 90 days, IOPs were measured at 8 am, 10 am, and 4 pm at months 6, 9, and 12. Roclatan IOP lowering exceeded that of both latanoprost and Rhopressa in a range from 1 to 3 mmHg. Levels of IOP lowering were consistent with those observed in the Mercury 1 and Mercury 2 90-day efficacy results for all arms of the study. Roclatan also demonstrated consistent levels of IOP lowering across the 12-month study period.
- Roclatan reduced mean diurnal IOPs to 16 mmHg or lower in 60 percent of patients, a significantly higher percentage than observed in the two comparator arms.
- The Rhopressa arm of the study performed consistently with previous phase 3 trials from both a safety and efficacy perspective. Rhopressa also demonstrated consistent levels of IOP lowering across the 12-month study period. At baseline IOPs below 25 mmHg, Rhopressa IOP lowering was similar to latanoprost at month 12.
“With these positive 12-month Mercury 1 data, we have again demonstrated the consistent and well-understood performance of Roclatan and Rhopressa from both a safety and efficacy perspective. Roclatan has the potential to become the most efficacious IOP-lowering therapy to enter the market, if approved, bolstered by an overall favorable safety and tolerability profile. We continue to expect to submit our Roclatan NDA (new drug application) in the first half of 2018,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.
“This data readout represents the last in our series of Phase 3 trials for both Roclatan and Rhopressa for approval in the U.S., and we are now actively engaged in preparations for the expected Rhopressa commercialization next year," Dr. Anido said.
Richard A. Lewis, MD, Aerie’s Chief Medical Officer, added, “As a clinician, I am very excited about the responder analysis data for Roclatan showing such a profound drop in IOP. We now have a robust understanding of the Roclatan safety profile and expect that clinicians will be highly satisfied with the 12-month safety and efficacy data.”