Rhopressa is a Rho-kinase and norepinephrine transporter inhibitor and lowers episcleral venous pressure, with phase 3 efficacy data expected mid-Q2 2015, and an FDA filing in mid-2016.
The Rhopressa “Rocket 1” registration trial is designed to evaluate non-inferiority to timolol BID. Entry criteria included pressures in the 20-27 mmHg range. (A phase 2b study comparing Rhopressa to latanoprost limited entry intraocular presure to 20-26 mmHg.) Rocket 2 will evaluate the 1-year safety and enroll about 230 patients in each of the three arms (Rhopressa QD and BID, and timolol BID).
“Rhopressa lowers IOP, regardless of whether the patient has high pressure or low pressure. It’s a differentiating characteristic,” Mitro said.
Rhopressa may be able to stop anti-fibrotic activity, may be able to provide more nutrients and antioxidants to the trabecular meshwork.
Roclatan combines Rhopressa and latanoprost; a phase 2b study achieved all clinical endpoints and a phase 3 will begin mid-year.
Thomas A. Mitro
Thomas A. Mitro has served as our President and COO since August 2013. From November 2012 to August 2013, Mr. Mitro served as Vice President, Sales and Marketing at Omeros Corporation.