After southern-California based pharmaceutical Aerie Pharma (AERI) reported favorable topline efficacy results for its Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 trial, shares soared to all-time highs surpassing the $51.85 mark notched in mid-March.
As a bit of background, Roclatan is a once-daily eye drop that combines Rhopressa with latanoprost, a widely-prescribed PGA. Based on the company’s preclinical studies and clinical trials to date, Aerie believes that Roclatan, if approved, would be the first glaucoma product to lower IOP through all known mechanisms: increasing fluid outflow through the trabecular meshwork, the eye’s primary drain; increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain; reducing fluid production in the eye, and; reducing episcleral venous pressure (EVP). Rhopressa, as described above, (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that AERI believes, if approved, would become the only once-daily product available that, based on the company’s preclinical and clinical studies to date, specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma.
Firstly, 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.
Most notably, the IOP-lowering effect of Roclatan was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either latanoprost or Rhopressa throughout the duration of the study.
Further, 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. Roclatan also reduced mean diurnal IOPs to 16 mmHg or lower in 56% of patients, a significantly higher percentage than observed in the two comparator arms.
On the safety front, the most common Roclatan adverse event was hyperemia, or eye redness, which was reported in nearly 55% 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.
Aerie expects to submit a Roclatan NDA to the U.S. Food and Drug Administration (FDA) in the first half of 2018. Additionally, the FDA has set the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review of the Rhopressa NDA for February 28, 2018.