The win for Aerie came after an expert panel voted 9-1 in the drug’s favor. Studies have found that Rhopressa lowers elevated intraocular pressure in the eye, but analysts have noted that the twice-daily generic timolol ophthalmic solution 0.5% is more effective for patients with severe cases of glaucoma.
“The approval of once-daily Rhopressa represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians. It is a testament to years of successful research and development and the incredible talents of our dedicated employees, to whom we owe much gratitude,” chairman & CEO Vicente Anido, Jr., said in prepared remarks.
“As we reflect on the Rhopressa approval, we pay tribute to Aerie’s late co-founder, Dr. David Epstein. He was a visionary in the field of glaucoma and always believed in the potential IOP-lowering benefits of Rho kinase inhibition. This is a fulfillment of his dream,” Anido added.
Aerie’s next product, Roclatan, combines Rhopressa with the generic latanoprost. The company plans to submit that drug for approval with the FDA in Q2 of 2018, according to Anido.
Despite the regulatory win, AERI shares were down -1.8% in pre-market activity.