The first FDA-approved drop for presbyopia can provide near vision and potentially bring more patients into your office.

The era of offering presbyopia patients a way to see up close without surgery and without reading glasses is at hand.

In October, Allergan’s VUITY (pilocarpine HCl ophthalmic solution) 1.25% received FDA approval, making it the only FDA-approved prescription eyedrop to treat presbyopia. “This is a unique offering in the eye-care space,” says George O. Waring IV, MD, FACS, medical director, Waring Vision Institute, Mount Pleasant, S.C. Dr. Waring served as principal study investigator for the drug’s GEMINI 1 and GEMINI 2 Phase 3 clinical studies.

VUITY, Dr. Waring notes, is the first eyedrop designed specifically to treat presbyopia. It “is specifically optimized for the treatment of presbyopia that distinguishes it from the historic preparations of pilocarpine,” he says.

CLINICAL DATA

According to a company press release, the FDA approval of VUITY is based on data from the GEMINI 1 and GEMINI 2 studies, which evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia. In both studies, VUITY met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions without a loss of distance vision vs the vehicle (placebo) on day 30 at hour 3.

Allergan reports that improvement was seen as early as 15 minutes and lasted through 6 hours.

“The primary mechanism of action is through reduction in pupil size, which increases the depth of focus through a small aperture optical principle,” says Dr. Waring, a refractive and cataract surgeon who specializes in the treatment of presbyopia. In addition, some evidence suggests a possible secondary mechanism of an accommodative effect, he notes. “There was statistically significant improvement in both near and intermediate vision without reduction in distance vision,” he says.

In addition to the rapid onset of improvement in near vision, Dr. Waring points to three other major lessons learned from the GEMINI studies:

1. Distance vision was preserved
2. Improvement in intermediate vision lasted up to 10 hours with statistical significance
3. VUITY was well tolerated, relative to the historic concentrations and preparations of pilocarpine. No serious adverse events were observed in either study. “We found the side effect profile to be excellent,” he says.

GOING NEUTRAL

VUITY uses Allergan’s proprietary pHast technology, which allows VUITY to quickly adjust to the physiologic pH of tear film. This ability to rapidly adjust to the natural pH of tear film, according to Dr. Waring, increases the drug’s penetration, which makes the drug more bioavailable in the eye and better tolerated relative to historic preparations of pilocarpine.

Allergan has found a way for the drug, which is acidic in the bottle, to equilibrate to a neutral pH when the medication touches the ocular surface, says Sumit (Sam) Garg, MD, vice chair of clinical ophthalmology, medical director, and professor in cataract, refractive, external disease and corneal surgery at the Gavin Herbert Eye Institute at the University of California, Irvine. This allows for less burning and stinging on instillation, he notes, as well as better absorption.

PATIENT POPULATIONS

With its broad labeling, VUITY can benefit more than just mild to moderate presbyopes, according to Dr. Waring. VUITY can aid patients with iatrogenic presbyopia, pseudophakia and patients who previously had LASIK who are now presbyopic and in the earlier stages of lens dysfunction.

In particular, Dr. Garg expresses an interest in trying VUITY with pseudophakic patients who have achieved a distance goal and then convey an interest in not having to use reading glasses.

“Now we have an opportunity to say, ‘Let’s try this drop to see if we can get you some better near vision,’ because pinhole optics shouldn’t make a difference whether you have a natural lens or an artificial lens,” Dr. Garg says.

Unlike reading glasses where any patient with the same refractive error is likely to achieve similar outcomes, the benefit a presbyopic patient could get from VUITY may vary, Dr. Garg notes.

“Some of what we’re going to learn over the first few months or longer of using this is trying to figure out where the sweet spot is for what patient will get the most benefit,” he says.

NEW DEMOGRAPHIC

Besides the direct benefit of addressing presbyopia, VUITY also is likely to help bring more patients into eye-care offices, allowing practitioners to address more problems. “It’s going to bring in patients who normally don’t seek eye care,” says Dr. Garg.

The practitioner, who could be an optometrist, could then detect conditions like glaucoma, or retinal or corneal pathology, he notes.

While other drugs to treat presbyopia are in development, VUITY represents the pathfinding drug for a massive number of potential patients. OM