Drugs / SIMBRINZA
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Simbrinza | — | 2014-07-18 | europa.eu ↗ |
| Approved | US (FDA) | SIMBRINZA | — | 2013-04-19 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 42 trials | ||||||
| Phase 4 | NCT01937299 | Oct 2013 → Apr 2014 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01937312 | Oct 2013 → May 2014 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT02167035 Comparator | Aug 2014 → Mar 2018 | glaucoma, ocular hypertension | Cornerstone Health Care, PA | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-04-28 | Alcon Research | Alcon to Acquire U.S. Commercialization Rights to Ophthalmic Eye Drop Simbrinza alcon.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Simbrinza | “The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or...” NCT01937299 ↗ |
| Known as | SIMBRINZA Suspension | “SIMBRINZA® Suspension” NCT01937312 ↗ |
| Route | Other | “1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM)” NCT01937312 ↗ |