EyeWorld Asia-Pacific March 2016 Issue

March 2016 Glaucoma treatment 32 EWAP SECONDARY FEATURE Dual-action Rhopressa (AR-13324) Source: Aerie Pharmaceuticals Finding new therapies in glaucoma by Vanessa Caceres EyeWorld Contributing Writer What’s on the horizon in the U.S. for new glaucoma agents T he Ocular Hypertension Treatment Study (OHTS) showed that 40% of glaucoma patients required at least two medications to lower their intraocular pressure (IOP) by 20%. 1 With landmark studies like OHTS showing the need for better IOP-lowering therapies, U.S.-based glaucoma specialists are particularly interested in eye drops that may be approved soon—or relatively soon— by the U.S. Food and Drug Administration (FDA), said Jason Bacharach, MD , North Bay Eye Associates, Petaluma, Calif. What’s closest on the horizon The agent that has made it furthest along the FDA path AT A GLANCE • There is a need in glaucoma to develop additional IOP-lowering treatments. • Two glaucoma agents currently in phase 3 trials are a Rho kinase inhibitor and a Rho kinase inhibitor combined with a prostaglandin analogue. • The lack of additional therapies may be related to return on investment and risk. • The FDA could have a growing collaborative role for future drug development. to approval is the Rho kinase inhibitor Rhopressa 0.02% (Aerie Pharmaceuticals, Irvine, Calif.), a triple-action eye drop. If approved, it would be a once-daily agent that targets the trabecular meshwork, Dr. Bacharach said. Rho kinase inhibitors are a new class of treatment within glaucoma. Another Rho kinase inhibitor called Glanatec ophthalmic solution 0.4% (ripasudil hydrochloride hydrate, Kowa Company, Japan), was approved in Japan late last year for twice-daily treatment of glaucoma and ocular hypertension. Preclinical research showed that Rhopressa helps to reduce episcleral venous pressure, one of the factors in IOP. The agent also reduces fluid production in the eye by inhibition of norepinephrine transporter, Dr. Bacharach said. In its initial trial, Rocket 1, Rhopressa did not meet its primary endpoint of demonstrating non- inferiority of IOP compared to twice-daily timolol based on IOP measurements at the end of week 2, week 6, and day 90, said Tony Realini, MD , MPH , associate professor of ophthalmology, West Virginia University, Morgantown. However, it did meet its primary endpoint in September in the Rocket 2 trial, he added. When dosed once daily and twice daily, Rhopressa achieved its primary efficacy endpoint and demonstrated non-inferiority compared to twice-daily timolol, according to a company press release. The primary efficacy endpoint included subjects with pre-study baseline IOPs of above 20 to below 25 mmHg, the release stated. Rhopressa is currently in phase 3 trials. Aerie Pharmaceuticals will collect more long-term safety data and plans to release that information later this year or early in 2016. It then plans to file a new drug application in 2016, the company press release stated. “Its prospects for approval, and any continued on page 34