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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 Pilocarpine HCl, Pilocarpine HCl Ophthalmic Solution, AGN-190584
Pilocarpine · 4 trials · 1 indication
Visual acuity for near (40 centimeter \[cm\]) and distance (4 meter \[m\]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.
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.
Visual acuity for near (40 centimeter (cm)) and distance (4 meter (m)) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions measured at the target. Forced choice letter by-letter scoring was used for each test and the total number of correct letters or the highest value (number) of the grid identified (as applicable) were recorded. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. DCNVA= distance-corrected near visual acuity.
Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
| Arm | Type | Description |
|---|---|---|
| Vehicle | PLACEBO_COMPARATOR | Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days. |
| AGN-190584 | EXPERIMENTAL | AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days. |
| 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). |
| Pilocarpine HCl Ophthalmic Solution | EXPERIMENTAL | Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days. |
| Name | Type | Description |
|---|---|---|
| Pilocarpine HCl | DRUG | Pilocarpine HCl ophthalmic solution 1.25% ocular drops. |
| Vehicle | DRUG | Oxymetazoline HCl and pilocarpine HCl placebo ocular drops. |
| AGN-190584 | DRUG | Topical eyedrop |
| Pilocarpine HCl Ophthalmic Solution | DRUG | Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. |
Inclusion Criteria: \- Objective and subjective evidence of presbyopia. Exclusion Criteria: * 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 (S...
Pilocarpine is being developed as an ophthalmic solution for presbyopia, the age-related loss of near vision. It is a small molecule formulated for topical use in the eye and is given as a drop in both eyes. The clinical program enrolled adults age 40 and older with presbyopia.
Pilocarpine targets the muscarinic acetylcholine receptors CHRM1 and CHRM3, where it acts as an agonist. By activating these receptors, it is designed to affect the muscles that control pupil size and focus. This mechanism underlies its development as an eye drop for presbyopia.
AbbVie Inc. (ticker ABBV) is developing pilocarpine as an ophthalmic solution for presbyopia. The program has been studied under the designation AGN-190584 in Phase 3 clinical trials conducted in the United States.
Pilocarpine for presbyopia is in Phase 3 development. It is an investigational ophthalmic solution and is not described as approved. Three Phase 3 trials have been completed, and no trials are currently listed as active.
Three completed Phase 3 trials have studied pilocarpine for presbyopia: NCT04983589, which enrolled 230 participants; NCT03857542, which enrolled 427 participants; and NCT03804268, which enrolled 323 participants. All three were randomized, double-blind, placebo-controlled studies conducted in the United States in adults age 40 and older.
Yes. Pilocarpine is also known as pilocarpine HCl and pilocarpine HCl ophthalmic solution. These names refer to the same small molecule developed by AbbVie for presbyopia, and the trial listings use the designation AGN-190584 for the same ophthalmic solution.