Drugs / AGN-190584
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | presbyopia | 2021-02-25 | “submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia.” abbvie.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT05393089 | Jun 2022 → Apr 2023 | presbyopia | Allergan | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02780115 | May 2016 → Oct 2017 | presbyopia | Allergan | Completed | Met primary |
| Phase 2 | NCT02595528 | Apr 2016 → Oct 2017 | presbyopia | Allergan | Completed | Met primary |
| Phase 2 | NCT02197806 | Jul → Oct 2014 | presbyopia | Allergan | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT04837482 | May → Dec 2021 | presbyopia | AbbVie | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05624320 | Dec 2022 → May 2023 | presbyopia | Gordon Schanzlin New Vision | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-04-05 | AbbVie | Results Allergan, an AbbVie Company, Announces Positive Topline Phase 3 Results Evaluating Investigational Twice-Daily Administration of VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in Adults with Age-Related Blurry Near Vision (Presbyopia) abbvie.com ↗
In the VIRGO trial evaluating twice-daily administration of VUITY, the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met |
| 2021-10-29 | AbbVie | Regulatory U.S. Food and Drug Administration Approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only Eye Drop to Treat Presbyopia (Age-Related Blurry Near Vision) abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced the U.S. Food and Drug Administration (FDA) approval of VUITY ™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. |
| 2021-07-25 | AbbVie | Results New Data Presented on the Safety and Efficacy of Investigational AGN-190584 as a Potential Novel Treatment for Presbyopia, a Common and Progressive Eye Condition abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. |
| 2021-04-30 | AbbVie | Regulatory AbbVie Reports First-Quarter 2021 Financial Results abbvie.com ↗
AbbVie announced that it submitted a NDA to the FDA for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. |
| 2021-02-25 | AbbVie | Regulatory Allergan, an AbbVie Company, Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. |
| 2020-10-28 | AbbVie | Results Allergan, an AbbVie Company, Announces Positive Phase 3 Topline Results for Investigational AGN-190584 for the Treatment of Presbyopia abbvie.com ↗
Allergan, an AbbVie (NYSE: ABBV) company, today announced the Phase 3 GEMINI 1 and 2 clinical trials evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of symptoms associated with presbyopia, met their primary efficacy endpoint. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AGN-190584 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02780115 ↗ |
| Known as | pilocarpine | “AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle.” NCT04837482 ↗ |
| Route | Other | “1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.” NCT02197806 ↗ |