A Phase 3 Efficacy Study of 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 PRK or LASIK with 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 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