Aerie Pharmaceuticals Reports Positive Phase 3 Topline Efficacy Results for Roclatan
Source: Aerie Pharmaceuticals
Aerie Pharmaceuticals reported the successful primary efficacy results of the company’s 90-day, phase 3 Mercury 2 registration trial for its fixed-dose combination product candidate, Roclatan. The results of Mercury 2 were consistent with the successful 90-day efficacy results from the Mercury 1 trial, a 12-month phase 3 registration trial for Roclatan, which reported topline efficacy findings in September 2016.
Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components, 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 IOP-lowering effect of Roclatan was 1 to 3 mmHg greater than monotherapy with either latanoprost or Rhopressa throughout the duration of the study. The study evaluated patients with maximum baseline IOPs ranging from above 20 to below 36 mmHg.
- Roclatan dosed once daily achieved the primary efficacy endpoint of demonstrating statistical superiority over both latanoprost and Rhopressa at the primary endpoint range of baseline IOPs from above 20 to below 36 mmHg for each of the nine measured time points.
- IOPs were measured at 8 a.m., 10 a.m., and 4 p.m. at week 2, week 6, and day 90. Roclatan IOP lowering exceeded that of latanoprost in a range of 1.5 to 2.4 mmHg for an average of 1.8 mmHg, and exceeded Rhopressa IOP lowering in a range of 2.2 to 3.3 mmHg for an average of 2.7 mmHg. Efficacy levels were consistent across the 90-day period for all arms in the study.
- Roclatan reduced mean diurnal IOPs to 16 mmHg or lower in 56 percent of patients, a significantly higher percentage than observed in the two comparator arms.
- Discontinuation rates for the 90-day period for Roclatan and Rhopressa were approximately 10 percent for each product candidate, representing the lowest discontinuation rates experienced across all Phase 3 trials of Roclatan and Rhopressa.
- The most common Roclatan adverse event was hyperemia, or eye redness, which was reported in nearly 55 percent of patients, was sporadic, and was scored as mild for the large majority of these patients, generally consistent with previous trials. There were no drug-related serious or systemic adverse events for any of the treatment groups. (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005.
“With this positive Mercury 2 data, we now have two successful pivotal trials for Roclatan. The topline efficacy results demonstrated in Mercury 2 are consistent with Mercury 1, confirming the potential for Roclatan to become the most efficacious IOP-lowering therapy to enter the market, if approved. Now that the efficacy results for both Mercury 1 and 2 have proven successful, and if the Mercury 1 12-month safety results are also successful, we 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. “In addition to the excellent efficacy observed in Mercury 2 for both Roclatan and Rhopressa, we were also delighted to see relatively low discontinuation rates for the 90-day Mercury 2 trial of 9.8 percent and 10.6 percent for Roclatan and Rhopressa, respectively.”
Roclatan is distinguished by its ability to lower intraocular pressure to levels previously unseen with current glaucoma therapies, including market-leading latanoprost," Richard A. Lewis, MD, Aerie’s Chief Medical Officer, said in the news release. “This product holds the promise of potentially becoming the first prostaglandin fixed-dose combination available in the United States. The safety profile of Roclatan observed in Mercury 2 once again points to a safe and tolerable product.”
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