Aerie Pharmaceuticals

Rhopressa is a Rho-kinase inhibitor that increases the outflow of the trabecular meshwork by relaxing it. It’s also a norepinephrine transport inhibitor that decreases the amount of fluid being produces, and drops episcleral venous pressure. Aerie has completed two phase III trials, with the Rocket 2 data being used to file the NDA for the QD version. Rocket 1 will be used as supportive data to the filing; additional safety data will be available in early 2016. A 6-month safety and efficacy study (Rocket 4) will have a 90-day read out for both efficacy and safety; while not necessary for the FDA filing, it will include data on an additional 600 patients necessary as supportive data for the European filing.

Roclatan is a combination of Rhopressa with latanoprost that entered phase III trials this year. Phase 2 data from 2014 showed the combination was actually statistically superior against each individual component over the nine time points that were measured over a 90-day period.

Mercury 1 is an ongoing 12-month study designed to have a 90-day efficacy read-out and then 12-month safety data. In 2Q2016, the company plans to initiate Mercury 2, with the same study design as Mercury 1 but without the safety component.

The company is also analyzing 3,000-4,000 molecules, including AR13154, a small Rho-kinase inhibitor that also inhibits JAK2 as well as PDGF-Receptor beta. That molecule will enter development for wet age-related macular degeneration (AMD). A preclinical model suggests AR13154 is as successful in reducing neovascularization as another commonly used treatment, aflibercept.

The company has partnered with GrayBug to develop mechanisms of delivering products to the posterior segment. Aerie is also partnering with Tel Aviv University to bring a beta amyloid small molecule (EG30) into trials for neuroprotection and dry AMD.

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