Orasis Pharmaceuticals Presents New Data Showing Qlosi Is Pupil Selective in Presbyopic Eyes
Orasis Pharmaceuticals announced new clinical data demonstrating that 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.
“The perception of pilocarpine historically has been based on experience with, and research conducted on, higher concentrations of pilocarpine (1% and above),” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “Qlosi demonstrating minimal ciliary muscle movement, the same as the control tested, is consistent with the results we have seen in real-world experience to date—very low rates of adverse events overall without a single serious adverse event reported since launch. We believe this further illustrates why formulation matters and why the concentration-dependent effects demonstrated by Qlosi reinforce how our product was designed with the safety of the presbyopia patient in mind.”
The prospective, head-to-head clinical study was conducted by the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine. Investigators analyzed thousands of high-resolution optical coherence tomography (OCT) images to evaluate how balanced salt solution (BSS), Qlosi (0.4% pilocarpine), and pilocarpine 2% responded to presbyopic patients’ visual demands. Measurements included ciliary muscle movement, pupil diameter, and lens thickness.
Ten subjects were enrolled in the study, with a mean age of 51.5 years (range 46.3–64.3) and spherical equivalents ranging from −4.00D to +2.00D. Exclusion criteria included prior ocular surgery or ocular comorbidities.
Results showed that Qlosi significantly reduced pupil diameter while producing no significant changes in lens thickness or ciliary muscle response compared with BSS (P<0.05). In contrast, pilocarpine 2% produced statistically significant ciliary muscle movement at near, an effect not observed in either the BSS or Qlosi groups.
“In this study, pilocarpine 0.4% was indistinguishable from the BSS control, while the high-concentration miotic (pilocarpine 2.0%) triggered statistically significant movement of the ciliary muscle at near,” said Florence Cabot, MD, Assistant Professor of Clinical Ophthalmology at Bascom Palmer Eye Institute in Miami. “These findings are very encouraging, supporting that pilocarpine 0.4% is pupil selective and behaves in a concentration-dependent manner, reinforcing that low-concentration options may be particularly meaningful for patients considering a presbyopia therapy that balances both efficacy and safety.”
The new data build on results from pivotal phase 3 clinical trials in which Qlosi demonstrated a favorable safety profile, with no serious side effects reported. Additionally, in the first 10 months of real-world use following launch, there have been no reported cases of retinal detachment or other serious adverse events associated with Qlosi.
Originally published online on Eyewire+.