Aerie Pharmaceuticals announced topline data from the Mercury 1 study, a Phase 3 trial evaluating the fixed-dose combination product, Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, to lower intraocular pressure (IOP) in patients with glaucoma.
Mercury 1, the first Phase 3 registration trial for Roclatan, was a 12-month safety study in 718 patients with glaucoma. Patients either received the fixed-dose Roclatan or its individual components, which includes Rhopressa (netarsudil ophthalmic solution; Aerie) 0.02% or latanoprost, all given once daily in the evening. The primary efficacy endpoint was superiority over each of the components of Roclatan over 90 days.
Findings showed that Roclatan demonstrated statistical superiority over each of its component, achieving the study’s primary endpoint. Roclatan exhibited an IOP lowering effect which exceeded that of Rhopressa by 1.8–3mmHg and that of latanoprost by 1.3–2.5mmHg throughout the study duration. In addition, the mean diurnal IOP-lowering for Roclatan exceeded that of Rhopressa and of latanoprost by 2.6mmHg and 1.9 mmHg, respectively. The most common adverse events observed for Roclatan was hyperemia, or eye redness, which predominantly presented as mild in nature. No serious drug-related adverse events were reported for any of the comparators in the trial.
Aerie is currently investigating Roclatan in the Mercury 2 study, a second, 90-day, Phase 3 registration trial for the same indication. The Company expects to file a New Drug Application (NDA) for Roclatan to the FDA upon successful completion of both trials. If approved, Roclatan has the potential to become the first glaucoma product to lower IOP through all known mechanisms: increasing fluid outflow through the trabecular meshwork and the uveoscleral pathway, reducing fluid production in the eye, and reducing episcleral venous pressure (EVP).
Roclatan is a once-daily ophthalmic solution which combines Rhopressa, Aerie’s investigational glaucoma product, and latanoprost, a prostaglandin analogue (PGA).
For more information visit AeriePharma.com.