A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

Inclusion Criteria Subjective complaints of poor near vision that impact activities of daily living Exclusion Criteria Uncontrolled systemic disease Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. However, participants with history of photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA) meeting inclusion criteria will be allowed to enroll. Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study Participation in a blood or plasma donation program within 30 days prior to study intervention administration Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity Narrow iridocorneal angles (Shaffer grade ≤ 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy Diagnosis of any type of glaucoma or ocular hypertension Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history Females who are pregnant, nursing, or planning a pregnancy during the study