Aerie Pharmaceuticals just submitted a new drug application for Roclatan.
What is Roclatan?
It’s a drop used once daily to lower IOP and it’s a combo of two drugs, latanoprost and Rhopressa.
Rhopressa was just FDA approved at the end of last year (previous rundown on Rhopressa here). Latanoprost is the generic of Xalatan which was FDA approved in 1996.
Tell me about the clinical trials.
There are two Phase 3 trials, Mercury 1 and Mercury 2. Both studies have shown Roclatan to be better at lowering IOP (by 1-3mmHg) than Rhopressa or latanoprost alone.
When we will hear something?
Around 10 months from now. Typically new drug applications take one year to review but this one will be quicker because it’s a combo of two previously FDA approved drops. (via)
