NEW YORK (Reuters Health) - A new formulation of pilocarpine (Vuity, Allergan) was shown to improve presbyopia in a pivotal phase 3 trial.
The 1.25% pilocarpine solution was approved by the US Food and Drug Administration in October 2021.
It is not approved outside of the U.S, "though Allergan is exploring the potential to work with regulatory agencies worldwide to bring Vuity to patients in need," principal study author Dr. Michael Robinson of AbbVie noted in an email to Reuters Health.
The new formulation, referred to in the JAMA Ophthalmology study as AGN-190584, "is delivered with proprietary pHast technology, which allows (it) to rapidly adjust to the physiologic pH of the tear film," Dr. Robinson said. "This was studied in simulated tear film, and the clinical significance is unknown. Vuity uses the eye's own ability to reduce pupil size, which may improve near and intermediate vision while maintaining distance vision."
The multicenter, vehicle-controlled randomized, phase 3 trial, GEMINI 1, enrolled 323 adults with presbyopia. Randomization was stratified by factors including age, iris color, baseline mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA), and emmetrope status.
The mean age was 49.6; 73% were women; 90% were white; and the baseline mean mesopic DCNVA was 29.2 letters.
