FDA Approves First Eye Drop to Treat Presbyopia

The Food and Drug Administration (FDA) has approved Vuity (pilocarpine HCI ophthalmic solution) for the treatment of presbyopia in adults.

Vuity is a cholinergic muscarinic receptor agonist designed to improve near and intermediate vision without impacting distance vision by contracting the iris sphincter muscle, which constricts the pupil. Vuity also contracts the ciliary muscle and may shift the eye to a more myopic state.

The approval was based on data from the phase 3 GEMINI 1 (ClinicalTrials.gov Identifier: NCT03804268) and GEMINI 2 (ClinicalTrials.gov Identifier: NCT03857542) studies that evaluated the efficacy and safety of Vuity in a total of 750 patients aged 40 to 55 years with presbyopia. Patients were randomly assigned 1:1 to receive Vuity or vehicle, 1 drop once daily into each eye.

Results from the GEMINI 1 and GEMINI 2 studies showed that 31% and 26% of patients treated with Vuity, respectively, met the primary endpoint achieving 3-lines or more in mesopic, high contrast, binocular distance corrected near visual acuity, without losing more than 1 line (5 letters) of corrected distance visual acuity with the same refractive correction on day 30 at hour 3, compared with 8% and 11% of patients in the vehicle group (P <.01). The treatment was found to work as early as 15 minutes and lasted up to 6 hours, as measured on day 30.

As for safety, the most common adverse reactions reported were headache and conjunctival hyperemia. There were no serious adverse reactions observed in either study.

“Vuity offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision,” said George O. Waring IV, MD, FACS, medical director, Waring Vision Institute, South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator. “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 1 drop daily, particularly for those with mild to moderate presbyopia.”  

Vuity is supplied as a sterile ophthalmic solution containing pilocarpine hydrochloride 1.25%.

References

1. U.S. Food and Drug Administration approves Vuity™ (pilocarpine HCI ophthalmic solution) 1.25%, the first and only eye drop to treat presbyopia (age-related blurry near vision). News release. AbbVie. October 29, 2021. Accessed November 1, 2021. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-vuity-pilocarpine-hci-ophthalmic-solution-1-25-the-first-and-only-eye-drop-to-treat-presbyopia-age-related-blurry-near-vision-301412259.html. 
2. Vuity. Package insert. AbbVie; 2021. Accessed November 1, 2021. https://www.rxabbvie.com/pdf/vuity_pi.pdf.