FDA Approves Pilocarpine HCI Ophthalmic Solution 1.25% for Treatment of Presbyopia

The US Food and Drug Administration (FDA) has approved pilocarpine HCI ophthalmic solution 1.25% (VUITY) for the treatment of age-related blurry near vision, or presbyopia.

Presbyopia reduces the eye’s ability to focus on near objects and hardens the eye’s clear lens behind the iris and cannot change shape easily, causing difficulty in focusing on near objects.

The approval, granted to Abbvie, is the first and only currently available eye drop to treat the condition, which affects 128 million people in the United States.

Agent

The ophthalmic solution is a daily, prescription eye drop that works in as little as 15 minutes and will last up to 6 hours, as measured on day 30. It works to improve near and intermediate vision without an impact on distance vision.

Noted for its specific design for presbyopia, the agent is an optimized formulation of pilocarpine that is delivered with the company’s pHast™ technology. It allowed the solution to rapidly adjust to the physiologic pH of the tear film. Further, the agent used the eye’s own ability to reduce pupil size to improve near vision.

Phase 3 Data

The approval followed data from 2 phase clinical studies, including the GEMINI 1 and GEMINI 2, that evaluated efficacy, safety and tolerability of pilocarpine HCI ophthalmic solution 1.25% for presbyopia.

A total of 750 participants aged 40 - 55 years old with age-related blurry near vision were randomized 1:1 to the ophthalmic solution or placebo. They were required to administer 1 drop daily in each eye.

The agent met the primary endpoint in both studies, reaching statistical significance. Participants treated with the ophthalmic solution gained 3 lines (ability to read 3 additional lines on a reading chart) or more in mesopic, high contrast, binocular Distance Corrected Near Visual Acuity and did not lose more than 1 line of Corrected DIstance Visual Acuity.

No serious adverse events were observed, with the most common adverse events consisting of headache and eye redness at a frequency of >5%.

Reaction

In a statement, Michael Severino, MD, vice chairman and president, Abbvie, noted the FDA approval exemplified the innovative new treatments that help push the boundaries on eye care possibility.

"We are proud to offer VUITY as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia,” Severino said.

Following that, in the same statement, the principal study investigator of GEMINI 1 and GEMINI 2, George O. Waring IV, MD, mentioned the approval now offers a safe and well-tolerated alternative to current options for managing age-related blurry near vision.

"I am particularly encouraged by the rapid onset of action and duration of efficacy for VUITY to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia,” Waring said.