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The FDA has approved pilocarpine hydrochloride 1.25% ophthalmic solution (Vuity), the first eye-drop treatment for presbyopia, or age-related blurred near vision,

The approval allows for daily treatment of adults with presbyopia. An estimated 128 million Americans -- almost half the adult population -- are affected by the condition. In clinical trials, pilocarpine ophthalmic solution led to vision improvement as soon as 15 minutes after application and was maintained for 6 hours.

"As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close," said George O. Waring IV, MD, of Waring Vision Institute in Mount Pleasant, South Carolina, in the announcement. "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."

Support for the approval came from two phase III, randomized, placebo-controlled trials involving a total of 750 presbyopic patients ages 40 to 55. Patients self-administered a single drop of pilocarpine eye drop solution or a placebo solution once daily in each eye. Randomized treatment continued for 30 days.

Both trials met the primary endpoint, as significantly more patients randomized to the pilocarpine solution gained at least three lines in visual acuity without losing more than one line. No serious adverse events (AEs) occurred in either study. The most frequent non-serious AEs were headache and eye redness.

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