Eyeworld

53 EW FEATURE November 2015 • Glaucoma medical treatment each of its components—latanoprost and Rhopressa—in IOP reduction," said Dr. Bacharach, who is a consul- tant for the company. "If approved, it will be the first fixed-combination drug with a prostaglandin compo- nent in the U.S." "This suggests that Rhopres- sa may be better positioned as an adjunct to prostaglandin analogues rather than as an alternative first line therapy to prostaglandins," Dr. Realini said. "We will need more comparative data and some hands- on experience with these drugs before we can best determine their place in the paradigm." Another fixed-dose combina- tion, Simbrinza (Alcon, Fort Worth, Texas), was approved by the FDA in 2013, Dr. Novack said. The medi- cation combines brimonidine and brinzolamide and treats open-angle glaucoma or ocular hypertension. Still other agents that target the trabecular meshwork are making their way through clinical testing, Dr. Brubaker said. These include trabodenoson (Inotek, Lexington, Mass.), which is a selective adenos- ine mimetic that works at the A1 receptor subtype in the trabecular meshwork. Phase 2 trial results show that the drug may lower IOP to a similar level as prostaglandins, and phase 3 trials should begin by the end of this year, Dr. Brubaker said. 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 pri- mary 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 end- point and demonstrated non-in- feriority 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 mm Hg, the release stated. Rhopressa is currently in phase 3 trials. Aerie Pharmaceuticals will collect more long-term safety data and plans to release that informa- tion 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 potential labeling, remain unknown at present," Dr. Realini said. The approval of a Rho kinase inhibitor would bring a new class of agents to glaucoma for the first time in 20 years, said Jacob Brubaker, MD, Sacramento Eye Consultants, Sacramento, Calif. Dr. Brubaker has been part of the Rhopressa clinical trials. Fitting it in the treatment paradigm Just how Rhopressa may be used in the glaucoma paradigm will become clear during the phase 3 studies, said Gary D. Novack, PhD, president, PharmaLogic Development, San Rafael, Calif., and visiting professor of ophthalmology and pharmacol- ogy, University of California, Davis, School of Medicine. "I think that it should work throughout the spectrum of dis- ease," Dr. Brubaker said. "I still think that prostaglandins will likely remain first line, but the studies and clinical experience will reveal its efficacy as well as its tolerability." As Rhopressa tends to work bet- ter with lower baseline IOPs, it could prove to be a better treatment with low-tension glaucoma than what is currently available, Dr. Brubaker said. "At this point, this is specula- tion, and further study will have to be directed toward these patients in the future." Another agent under develop- ment is a combination drug called Roclatan, also from Aerie, that com- bines Rhopressa with latanoprost. "In phase 2 trials, it outperformed Seeking more glaucoma treatment innovation Financial hurdles may have been the reason for some stagnation in glaucoma treatment innovation, Dr. Novack thinks. "Drug develop- ment is primarily sponsored by the private sector and is dependent on perceived return on investment," he said. He still thinks there is financial opportunity for the development of new glaucoma medications, even if they are not first line therapy. He also thinks that new drug delivery systems could be a win-win for both glaucoma specialists and patients. "Innovation for finding new therapeutic targets and developing novel drugs with unique mecha- nisms of action is more expensive, time-consuming, and risky," Dr. Realini said. He speculated that limiting the development of the number of similar drugs in a given class could possibly spur innovation, so drug makers would not focus on therapies that are nearly identical to what is already in the marketplace. That said, right now is actually a good point in time for glaucoma drug innovation, Dr. Brubaker said. "There is more interest in novel agents than there has been for quite some time since prostaglandins came on the scene," he said. "Since then, the majority of research has been directed toward improving EyeWorld Monthly Pulse EyeWorld Monthly Pulse is a reader survey on trends and patterns for the practicing ophthalmologist. Each month we send an online survey covering different topics so our readers can see how they compare to our survey. If you would like to join the hundreds of physicians who take a minute a month to share their views, please send us an email and we will add your name. Email carly@eyeworld.org and put EW Pulse in the subject line. 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