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Label indication VUITY ® is indicated for the treatment of presbyopia in adults. VUITY is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 ) FDA label
Also known as AGN-190584 ophthalmic solution, Pilocarpine HCl, Pilocarpine HCl Ophthalmic Solution, VUITY
AGN-190584 · 1 trial · 1 indication
An overall composite driving Z-score approximately 1 hour after study intervention instillation was derived to capture the overall driving performance of each participant compared with the whole group for the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. For each participant, the Z-score for each task of the driving test was the difference between his/her value and mean value of the assessments of all participants from the pooled data of both periods combined, divided by the standard deviation of all corresponding assessment values. Because a lower percentage of hazards hit, lower percentage of time outside of the driving lane, and a shorter lap duration indicate better driving performance, the Z-scores of these components were reversed (multiplied by -1) before computing the overall composite driving Z-score. A higher Z-score indicates better driving performance.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| AGN-190584 Sequence 1 | EXPERIMENTAL | AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5). |
| AGN-190584 Sequence 2 | EXPERIMENTAL | AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5). |
| Name | Type | Description |
|---|---|---|
| AGN-190584 | DRUG | Topical eyedrop |
| Vehicle | DRUG | Topical eyedrop |
Inclusion Criteria: * In good general health at the screening visit, as determined by the investigator from medical history. * Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score \> = 3) on at least 1 question on NEI VFQ...
AGN-190584 is an investigational small molecule ophthalmic solution being developed by AbbVie Inc. for presbyopia, the age-related loss of near vision. It is a muscarinic receptor targeting eye drop. It has completed a Phase 3 clinical trial and is not yet approved.
AGN-190584 is being developed for the treatment of presbyopia, a condition in which the eye's ability to focus on close objects gradually declines with age. It is an investigational ophthalmic solution and has not been approved for any indication.
AGN-190584 targets muscarinic receptors. It is a small molecule ophthalmic solution designed to act on these receptors in the eye. The muscarinic receptor class is the stated molecular target for this investigational presbyopia therapy.
AGN-190584 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the company responsible for advancing this ophthalmic solution for presbyopia.
AGN-190584 is in Phase 3 clinical development for presbyopia. One Phase 3 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
AGN-190584 has been studied in a completed Phase 3 trial, NCT04837482, titled a study to assess the impact and adverse events of topical eyedrops of AGN-190584 on night-driving performance. The trial enrolled 43 participants in Australia and was randomized, double-blind, and controlled.
Yes, AGN-190584 ophthalmic solution is another name for AGN-190584. Both refer to the same investigational eye drop being developed by AbbVie for presbyopia. The ophthalmic solution designation describes its route of administration.