Duke spin-out Aerie Pharmaceuticals has been given permission to begin testing its drug in Canada.
Aerie Pharmaceuticals, a spin-out of Duke University, has secured a “no objection letter” to trial its glaucoma treatment in Canada. The company expects some 1,300 patients to enrol in in the three phase 3 trials of Rhopressa, two of which are running in the US.
If the phase 3 trials of Rhopressa prove successful and the drug is approved, the spin-out intends to commercialise the drug throughout North America. It will do so by setting up its own dedicated sales team, before partnering up with strategic distribution partners in other markets. The company wholly owns all related intellectual property rights for both Roclotan and Rhopressa, with patents through to 2030.
The company’s shares rose 25% in June 2014 when it announced the successful results for the phase 2b trial of its other drug Roclotan. Roclotan combines Rhopressa with Latanoprost, the currently prescribed treatment for glaucoma.
The market for glaucoma treatments is increasingly profitable for the pharma industry, with sales exceeding $4.5bn in the US, Europe and Japan. As the world’s population ages, prescription volume is expected to grow even further.
Vicente Anido Jr, chairman and CEO of Aerie, said: “Our third study, expected to commence later this quarter, will allow our clinical team to work closely with leading ophthalmology centres in Canada as they gain familiarity with Rhopressa and its potential for the treatment of individuals with glaucoma. Our phase 3 registration programme for Rhopressa continues on track to file an NDA by mid-2016, with top-line three-month efficacy results expected in the middle of next year based on current timelines.”
