Aerie Pharmaceuticals, a clinical-stage pharmaceutical company focussed on the discovery, development and commercialisation of first-in-class glaucoma therapies, announced that on August 29, dosing commenced of the first patients enrolled in the company's phase 3 registration trial in Canada of Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

The study, named "Rocket 3," is designed to evaluate safety and tolerability of Rhopressa in patients over a 12 month period and is part of a broad phase 3 programme being conducted by Aerie.

The Company recently announced the commencement of two phase 3 trials in the United States, "Rocket 1" and "Rocket 2," which are focussed on demonstrating non-inferiority of IOP lowering for Rhopressa compared to timolol, the most widely used comparator in registration trials for glaucoma. Aerie anticipates total enrollment of approximately 1,300 patients in the three phase 3 trials of Rhopressa.

"Our Rhopressa study in Canada is the third and final trial to commence in our phase 3 programme, which continues to show strong momentum and interest from the ophthalmology community. This trial will supplement the safety studies required to file our NDA in the United States, and potentially result in sufficient safety data for submission to the European regulatory authorities for product approval in Europe. Further, it establishes our name and presence in Canada, which could become an important market for Aerie in the future," stated Vicente Anido, Jr., Ph.D., chairman and chief executive officer at Aerie. "As previously announced, we anticipate top-line three-month efficacy results from the Rhopressa phase 3 programme in mid-2015 based on current timelines, with a potential NDA filing by mid-2016."

Pending progress of the Rhopressa phase 3 programme and regulatory approvals, Aerie intends to commercialize Rhopressa in North American markets with its own sales force and will seek commercialisation partners in other key territories, including Japan and possibly Europe. Aerie fully owns its product candidates, has no licences, and has patent protection for both use and composition of matter through 2030.

Rhopressa is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Recent preclinical results have demonstrated that Rhopressa also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, Rhopressa provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, Rhopressa is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET).

In the company's phase 2b clinical trial, which was successfully completed in June 2013, Rhopressa demonstrated a strong IOP-lowering effect, with mean IOP reductions of 5.7 and 6.2 mmHg on days 28 and 14, respectively. In addition, Rhopressa demonstrated a consistent mean IOP-lowering effect irrespective of the baseline IOPs of the patients entered into the trial. This differentiates Rhopressa from currently marketed IOP-lowering agents such as market-leading prostaglandin analogues (PGAs) and beta blockers, which have their highest effect at higher baseline IOPs, while losing efficacy as the baseline diminishes, as shown in published studies. This is meaningful given that the significant majority of glaucoma patients have low to moderately elevated IOPs of 26 mmHg or below at the time of diagnosis. In the Company's Roclatan phase 2b trial recently completed in June 2014, Rhopressa performed with similar results as it had in its Phase 2b trial completed in June 2013 and in addition demonstrated additive efficacy when used in combination with latanoprost, the most commonly prescribed PGA.

Pending successful advancement of the phase 3 registration studies, three-month efficacy results are expected to be released in mid-2015. If the trials are successful, the Company expects to submit a New Drug Application filing by mid-2016.