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Pilocarpine

Phase 4FDA approved

Presbyopia | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Oct 10, 2024

Pilocarpine development status

FDA approval on record Oct 28, 2021 as Vuity
Approval holderAbbvie
ApplicationNDA214028
Highest phase Phase 4 (NCT05624320)
Phase scored for ABBVPhase 3
Registered trials 5 across 4 sponsors since Jul 2014

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

Pilocarpine target and mechanism

Molecular targetCHRM1, CHRM3
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL550

Also known as Pilocarpine HCl, Pilocarpine HCl Ophthalmic Solution, AGN-190584

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment1,023

FDA Designations

No designations recorded

Pilocarpine clinical trials

Pilocarpine · 4 trials · 1 indication

Phase 3 4
NCT04983589A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice DailyPresbyopia
COMPLETED230 Analytics
NCT04837482A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of AgePresbyopia
COMPLETED43 Analytics
NCT03857542A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With PresbyopiaPresbyopia
COMPLETED427 Analytics
NCT03804268Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With PresbyopiaPresbyopia
COMPLETED323 Analytics
PHASE3COMPLETED
A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
PresbyopiaUnlock trial analytics
PHASE3COMPLETED
A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age
PresbyopiaUnlock trial analytics
PHASE3COMPLETED
A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
PresbyopiaUnlock trial analytics
PHASE3COMPLETED
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
PresbyopiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction
3 hours after second dose on Day 14

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.

Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation
One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)

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.

Number of Participants With Adverse Events
Enrollment to Day 71

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.

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA, Without Losing More Than 5 Letters of Mesopic, High-Contrast, Binocular CDVA With the Same Refractive Correction at Day 30, Hour 3
Baseline (Day 1) to Day 30 (Hour 3)

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.

Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
Baseline (Day 1) to Day 30 (Hour 3)

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.

Secondary Endpoints

Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction
3 hours after second dose on Day 14
Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
3 hours after second dose on Day 14
Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
3 hours after second dose on Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VehiclePLACEBO_COMPARATORParticipants 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-190584EXPERIMENTALAGN-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 1EXPERIMENTALAGN-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 2EXPERIMENTALAGN-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 SolutionEXPERIMENTALParticipants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.

Interventions

NameTypeDescription
Pilocarpine HClDRUGPilocarpine HCl ophthalmic solution 1.25% ocular drops.
VehicleDRUGOxymetazoline HCl and pilocarpine HCl placebo ocular drops.
AGN-190584DRUGTopical eyedrop
Pilocarpine HCl Ophthalmic SolutionDRUGPilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
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Eligibility Criteria

Age Range40 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites23

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...

Countries:United StatesAustralia
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Frequently asked questions about Pilocarpine

What is pilocarpine used for in presbyopia?

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.

What does pilocarpine target?

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.

Who is developing pilocarpine 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.

What phase is pilocarpine in for presbyopia?

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.

What clinical trials is pilocarpine in for presbyopia?

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.

Is pilocarpine the same as pilocarpine HCl ophthalmic solution?

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.