Aerie Pharmaceuticals has reported successful efficacy results for the phase III Mercury 2 trial on Roclatan, a fixed dose combination of Rhopressa (netarsudil ophthalmic solution, 0.02%) and latanoprost for treatment of elevated IOP.
Roclatan met its primary end-point of demonstrating statistical superiority over monotherapy with each of its components. The 90-day trial included patients with baseline IOP of 20–30 mm Hg, randomized to once-daily topical administration of Roclatan, netarsudil or latanoprost.
Patients who received Roclatan showed greater reductions in IOP compared with the other groups at all 9 measurement points. The average reduction was 1.8 mm Hg lower than that of latanoprost, and 2.7 mm Hg lower than netarsudil.
In addition, a significantly higher proportion of Roclatan patients achieved a mean diurnal IOP of 16 mm Hg or lower.
The product candidate appears to be well-tolerated, with only a 10% discontinuation rate. The most common side effect was hyperemia, which was considered mild for most patients. There were no drug-related serious or systemic adverse events for any of the treatment groups.
The results are consistent with the positive findings from the 12-month phase III registration trial, Mercury 1.
“With this positive Mercury 2 data, we now have two successful pivotal trials for Roclatan,” said CEO Vicente Anido, Jr., PhD. “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.”
If Roclatan is approved, Aerie believes it would be the first glaucoma product to lower IOP through all 4 mechanisms: increasing fluid outflow through both the trabecular meshwork and the uveoscleral pathway, reducing fluid production in the eye and reducing episcleral venous pressure.
Within an hour of Aerie’s press release, the company’s stock surged 32% in after-hours trading.