6/28/23, 10:55 PM GEMINI 1 Pathway Feedback Search Clinical Topics Home Studies GEMINI 1 GEMINI 1 Trial question What is the role of pilocarpine hydrochloride ophthalmic solution in patients with presbyopia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 73.0% female N = 323 27.0% male 323 patients (235 female, 88 male) Inclusion criteria: patients aged 40-55 years with presbyopia Key exclusion criteria: severe dry eye disease; history of intraocular surgery; history of glaucoma or ocular hypertension; anisocoria of > 1 mm between pupils under mesopic conditions Interventions N=163 pilocarpine hydrochloride (one drop of pilocarpine hydrochloride 1.25% in each eye, once daily, for up to 30 days) N=160 placebo (one drop of vehicle in each eye, once daily, for up to 30 days) Primary outcome Rate of the percentage of patients with improved mesopic, high-contrast, binocular distance- corrected near visual acuity at hour 3 on day 30 30.7 % 30.7 23.0 % 15.3 % Significant increase 8.1 7.7 % https://web.pathway.md/studies/recfl3gyT5eNJxuci 1/2 6/28/23, 10:55 PM GEMINI 1 Pathway NNH = 4 0.0 % Pilocarpine hydrochloride Placebo Significant increase in the rate of the percentage of patients with improved mesopic, high- contrast, binocular distance-corrected near visual acuity at hour 3 on day 30 (30.7% vs. 8.1%; AD 22.5%, 95% CI 14.3 to 30.8) Secondary outcomes Significant increase in the rate of the percentage of patients with improved mesopic, high- contrast, binocular distance-corrected near visual acuity at hour 6 on day 30 (18.4% vs. 8.8%; AD 9.7%, 95% CI 2.3 to 17) Significant increase in the rate of the percentage of patients who achieved 20/40 or better photopic, high-contrast, binocular distance-corrected near visual acuity at hour 1 on day 30 (92.5% vs. 73.9%; AD 18.7%, 95% CI 10.6 to 26.7) Significant increase in mean improvement of mesopic, high-contrast, binocular distance- corrected near visual acuity at hour 0.5 on day 30 (9.3 vs. 4.2; MD 5.1, 95% CI 3.7 to 6.5) Safety outcomes No significant difference in adverse events. Conclusion In patients aged 40-55 years with presbyopia, pilocarpine hydrochloride was superior to placebo with respect to the rate of the percentage of patients with improved mesopic, high-contrast, binocular distance-corrected near visual acuity at hour 3 on day 30. Reference George O Waring th, Francis W Price Jr, David Wirta et al. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Mar 3;e220059. Open reference URL https://web.pathway.md/studies/recfl3gyT5eNJxuci 2/2