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  • Refractive Mgmt/Intervention

    Review of: Safety and efficacy of AGN-190584 in individuals with presbyopia: The GEMINI 1 phase 3 randomized clinical trial

    Waring G IV, Price F Jr, Wirta D, et al. JAMA Ophthalmology, April 2022

    According to this phase 3 trial, Allergan’s proprietary AGN-190584 topical drops show promise for the treatment of presbyopia, significantly improving near visual acuity after 30 days with minimal treatment-emergent adverse events.

    Study design

    GEMINI 1, a placebo-controlled phase 3 trial, randomized 323 patients with presbyopia into an AGN-190584 treatment group (163 patients) or an AGN-190584 vehicle group (160 patients). AGN-190584 is an optimized 1.25% pilocarpine hydrochloride topical drop produced by Allergan and is designed for the management of presbyopia. Bilateral treatments were administered once daily for 30 days. Improvement in mesopic distance-corrected near visual acuity (DCNVA) was used as a primary measure of efficacy.


    At day 30, hour 3, significantly more patients showed improvement by 3 or more lines in DCNVA in the AGN-190584 group than in the vehicle group (30.7% vs 8.1%, respectively). Significant between-groups differences were also noted at hour 6 (AGN-190584 = 18.4%; vehicle = 8.8%). No serious adverse events were noted in either group.


    The between-group difference in mesopic DCNVA gains was not found to be statistically significant by hour 8. Although the study concluded acceptable safety and tolerability profiles, this could be controversial considering recent reports of Vuity pilocarpine drops being associated with retina tears.1

    Clinical significance

    According to this study, AGN-190584 has shown itself to be a nonsurgical option that improves distance-corrected near visual acuity for patients in the presbyopic age range, albeit with some risks. In practice, some patients appear to benefit while others less so. Anecdotally, we have seen the greatest benefit for those in early presbyopia; however, there is variability there as well. We see this as a great addition to the refractive surgery armamentarium, especially for those looking for a bridge between ideal ages for laser vision correction and lens replacement.

    Financial Disclosures: Dr. Luke Rebenitsch discloses financial relationships with OSRX Pharmaceuticals (Consultant/Advisor, Lecture Fees/Speakers Bureau, Stock Options); Legrande (Consultant/Advisor, Private Equity/Stock Holder); Carl Zeiss Meditec, FDA Ophthalmic Devices Committee (Consultant/Advisor); LENSAR, STAAR Surgical (Lecture Fees/Speakers Bureau).


    1 Eton E, et al. Rhegmatogenous retinal detachment following initiation of pilocarpine hydrochloride ophthalmic solution 1.25% for treatment of presbyopia. Retinal Cases & Brief Reports, 2022, published ahead of print.