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Pilocarpine · 3 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.
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. |
| 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. |
| 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 an investigational small molecule being developed for presbyopia, an age-related condition that reduces the eye's ability to focus on close objects. It is formulated as an ophthalmic solution and is intended to improve near vision in adults aged 40 and older. The drug is currently in Phase 3 clinical development.
Pilocarpine is a cholinergic agonist that works by stimulating muscarinic receptors in the eye, causing the pupil to constrict. This pinhole effect increases depth of focus and improves near vision, which is the basis for its use in presbyopia. The drug is administered as eye drops.
Pilocarpine is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is in Phase 3 clinical trials for presbyopia, with all studies completed in the United States.
Pilocarpine is in Phase 3 clinical development for presbyopia. Three Phase 3 trials have been completed, with a total enrollment of 980 participants. The drug is investigational and has not been approved by regulatory authorities.
Pilocarpine has completed three Phase 3 trials: NCT03804268 (323 participants), NCT03857542 (427 participants), and NCT04983589 (230 participants). All trials were conducted in the United States, enrolled adults aged 40 and older, and were randomized, double-blind, and placebo-controlled.
Yes, Pilocarpine is also known as AGN-190584 in clinical trials. The Phase 3 studies for presbyopia used the AGN-190584 designation, and the drug is being developed by AbbVie Inc. under this name.