Orasis Pharmaceuticals announced data supporting Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% is pupil selective, significantly reducing pupil diameter without a statistically significant change in ciliary muscle response in presbyopic eyes. These data were presented at The Hawaiian Eye & Retina 2026 Conference, the company said in a press release.
The prospective, head-to-head clinical study, conducted by the Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, evaluated thousands of high-resolution optical coherence tomography (OCT) images to measure how balanced salt solution (BSS), Qlosi (0.4% pilocarpine) and pilocarpine 2%, responded to presbyopia patients' vision demands by looking at ciliary muscle movement, changes in pupil diameter, and lens thickness. Ten subjects (mean age 51.5 years, range 46.3-64.3) were enrolled with spherical equivalent −4.00D to +2.00D. Exclusion criteria were prior ocular surgery or comorbidities.
The study findings showed Qlosi significantly reduced pupil diameter but produced no significant changes in lens thickness or ciliary muscle response, compared with BSS (P<.05). Pilocarpine 2% showed a statistically significant change in ciliary muscle movement at near not observed in the BSS and Qlosi groups.
In pivotal phase 3 clinical trials, Qlosi demonstrated a favorable safety profile, with no serious side effects reported. In real-world use of Qlosi in the first 10 months of launch, there have been no reported cases of retinal detachment, or serious adverse events, the company said in the press release. OM