Drugs / Bimatoprost SR
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | open-angle glaucoma | 2019-07-17 | “Food and Drug Administration ( FDA ) has accepted the company's New Drug Application (NDA) for Bimatoprost Sustained-Release (SR).” abbvie.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02247804 | Dec 2014 → Feb 2018 | ocular hypertension, open-angle glaucoma | Allergan | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2019-07-17 | AbbVie | Regulatory U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension abbvie.com ↗
Allergan plc (NYSE: AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the company's New Drug Application (NDA) for Bimatoprost Sustained-Release (SR). |
| 2019-03-14 | AbbVie | Results Allergan to Present New Data - "Extended Duration of Intraocular Pressure (IOP) Control with Intracameral Bimatoprost Sustained-Release (SR) Implant" -- Highlighting Clinical Advances at the American Glaucoma Society Annual Meeting abbvie.com ↗ |
| 2019-01-07 | AbbVie | Results Allergan Announces Positive 3-Month Topline Results from Second Phase 3 Study of Bimatoprost SR (Sustained-Release) Implant for Lowering Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension abbvie.com ↗
Allergan plc , (NYSE: AGN), a leading global pharmaceutical company, today announced positive 3-month topline results from the second pivotal clinical trial of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. |
| 2018-06-13 | AbbVie | Results Allergan Announces Positive Topline Phase 3 Clinical Data for Bimatoprost SR (Sustained-Release) Implant for IOP Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension abbvie.com ↗
In this first Phase 3 clinical study of 594 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by approximately 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol. |
All press releases naming this drug 4 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bimatoprost SR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02247804 ↗ |
| Route | Other | “an intracameral, biodegradable, sustained-release bimatoprost implant” PMID 36378864 ↗ Nov 2022 |