Aerie Pharma Says Roclatan Phase 2b Results Achieve All Clinical Endpoints

(RTTNews) - Aerie Pharmaceuticals Inc. (AERI) announced the successful results of its Phase 2b trial for once-daily, quadruple-action Roclatan, a combination of Aerie's triple-action Rhopressa with latanoprost, a prostaglandin analogue or PGA.

Roclatan achieved its primary efficacy endpoint of statistically significant superiority over each of its components on day 29. The Phase 2b 28-day clinical trial included 297 patients. The baseline intraocular pressures (IOPs) tested in the study ranged from 22 to 36 millimeters of mercury (mmHg). Roclatan lowered mean diurnal IOP on day 29 from 25.1 mmHg at baseline to 16.5 mmHg, a 34 percent decrease in IOP. Roclatan mean diurnal IOP reduction on day 29 was approximately 2 mmHg greater than latanoprost.

Roclatan efficacy exceeded that of latanoprost, the most widely prescribed glaucoma drug, by 1.6 to 3.2 mmHg across each time point evaluated during the study (8am, 10am, 4pm on days 8, 15 and 29). These results were statistically significant at all time points with p-values less than 0.05.

The most common Roclatan adverse event was hyperemia, or eye redness, which was reported in 40 percent of patients and was scored as mild for the large majority of the Roclatan patients.

Aerie's first-in-class product candidates are all single drop, once-daily medications that are well tolerated and have shown no systemic drug-related adverse events. Aerie fully owns its product candidates, has no licenses, and has patent protection for both use and composition of matter through 2030.

Roclatan is a once-daily eye drop that combines our triple-action Rhopressa with latanoprost, a prostaglandin analogue that is the most widely prescribed glaucoma drug. If approved, the company believes that Roclatan would be the first glaucoma product to lower IOP through all known actions: (i) increasing fluid outflow through the trabecular meshwork or TM or primary drain, (ii) increasing fluid outflow through the uveoscleral pathway or secondary drain, (iii) reducing fluid production in the eye and (iv) reducing episcleral venous pressure (EVP).

Rhopressa is a novel triple-action eye drop that the company believes, if approved, would become the only once-daily product available that specifically targets the TM, the eye's primary fluid drain and the diseased tissue responsible for elevated intraocular pressure or IOP in glaucoma.

Rhopressa is expected to begin three Phase 3 registration trials in July 2014, with total expected enrollment of approximately 1,300 patients. The trials will measure efficacy over three months and safety over 12 months. The primary efficacy endpoint of the trials will be to demonstrate non-inferiority of IOP lowering for Rhopressa (dosed once daily and twice daily) compared to timolol (dosed twice daily). There will be two trials conducted in the U.S., and one safety-only study in Canada.

Assuming the trials commence as expected in July 2014, three-month efficacy results are expected to be released in mid-2015, and if the trials are successful, the company expects to submit our NDA filing in mid-2016.