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Based on the results from the phase IIb trial described here and recently published in Ophthalmology, Aerie initiated a full phase III program for triple-action Rhopressa (AR-13324) in July 2014. Two efficacy trials are being conducted in the United States, designated “Rocket 1” and “Rocket 2.” The primary efficacy endpoint in both studies is the demonstration of non-inferiority in IOP lowering over 3 months for Rhopressa compared with timolol, the most widely used comparator in registration trials for glaucoma.
A third 12-month, safety-only registration trial (“Rocket 3”) is being conducted in Canada. Enrollment in the 400-patient “Rocket 1” trial was completed ahead of schedule in December 2014, allowing Aerie to announce in January that the expected timeline for reporting efficacy results from the study would be accelerated from mid-2015 to the middle of the second-quarter of this year. An efficacy read-out for “Rocket 2” will take place by mid-2015.
If the trials are successful, Aerie plans to submit a new drug application (NDA) for Rhopressa to the FDA by mid-2016. Rhopressa, which inhibits both rho kinase (ROCK) and norepinephrine transporter (NET), could 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, while also lowering episcleral venous pressure (EVP) and reducing fluid production in the eye. Pending regulatory approval, the company intends to commercialize Rhopressa in North American markets and possibly Europe with its own sales force and will seek commercialization partners in other key territories, including Japan and possibly Europe.
Next in the Aerie glaucoma pipeline is Roclatan (PG324), a once-daily, fixed-dose combination of Rhopressa with latanoprost, the most commonly prescribed prostaglandin analogue. If approved, Roclatan would be the first glaucoma product to lower IOP through all known mechanisms: increasing fluid outflow through the trabecular meshwork; increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain; reducing fluid production; and lowering EVP.
A successful 28-day phase IIb clinical trial of Roclatan in 297 patients with glaucoma or ocular hypertension was completed in June 2014. In the study, Roclatan achieved its primary efficacy endpoint of statistically significant superiority compared to its individual components in reducing mean diurnal IOP over baseline on day 29. It also demonstrated statistical superiority to each component at all time points. The results for the Rhopressa component were similar to those in the single-agent phase IIb study and the drug demonstrated additive efficacy when used in combination with latanoprost. Aerie expects to initiate phase III registration trials for Roclatan in mid-2015.
Aerie fully owns both Rhopressa and Roclatan, has no licenses, and has patent protection for both use and composition of matter through 2030.