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    Rocket 2 results may tip the scale

    After ongoing meetings with FDA, company agrees to file Rhopressa QD only; on point for Q3 filing

    Take-home message: Aerie recently reported the results of its second phase III registration trial in the United States named Rocket 2, where the primary efficacy endpoint was to demonstrate non-inferiority of IOP lowering for Rhopressa compared with timolol.

    Las Vegas—The “big three” market—United States, Europe, and Japan—accounts for almost $4.7 billion and 100 million prescriptions in the glaucoma market, said Aerie president and COO Tom Mitro here during the 2015 meeting of the American Academy of Ophthalmology.

    The United States alone accounts for more than $2.2 billion and 33 million prescriptions—the majority of initial therapy treatments today are prostaglandins. Latanaprost owns about one-third of the overall U.S. glaucoma market, with non-prostaglandin fixed combination agents a distant second at 15%.

    More from this author: Easier ways to identify compromised corneas

    Aerie’s triple-action, once-daily eye drop (Rhopressa) inhibits Rho Kinase (ROCK) and the norepinephrine transporter (NET), both novel biochemical targets for lowering of IOP, would mark the first new class of glaucoma medication in more than 2 decades. Rhopressa’s mechanisms of action relaxes the trabecular meshwork to increase outflow, its NET component inhibits fluid production, and it lowers episcleral venous pressure. Aerie’s second glaucoma medication (Roclatan) combines Rhopressa with latanoprost to also increase uveoscleral outflow. 

    Rhopressa will be “the future drug of choice as an adjunctive therapy to prostaglandin agonists when additional IOP lowering is desired,” Mitro said, declaring it “ideal” for patients with low-pressure or normal-tension glaucoma.

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    Roclatan will be a “future drug of choice for patients who require the maximal IOP lowering,” he added, and anticipates the “ideal” patient as someone who is already using two or more topical therapies, or treatment-naïve patients with high or very high IOP.

    Simply put, “Roclatan is the most potent boat in the harbor,” Mitro said.

    Update on Rhopressa

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