Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
400 µg Brimonidine · 3 trials · 3 indications
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Stage 1 | OTHER | Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant Stage 1 | OTHER | Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 400 µg Brimonidine Tartrate Implant Stage 2 | OTHER | Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant Stage 2 | OTHER | Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. |
| Sham (no implant) Stage 2 | SHAM_COMPARATOR | Stage 2: sham in both eyes on Day 1 and Month 6. |
| 400 µg Brimonidine Tartrate Implant | EXPERIMENTAL | 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
| 200 µg Brimonidine Tartrate Implant | EXPERIMENTAL | 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). |
| 400 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 200 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group A | EXPERIMENTAL | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| Name | Type | Description |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant | DRUG | 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
| 200 µg Brimonidine Tartrate Implant | DRUG | 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
| Sham (no implant) | OTHER | Sham in one or both eyes on Day 1 and Month 6. |
| 100 µg Brimonidine Tartrate Implant | DRUG | 100 µg brimonidine tartrate implant in the study eye on Day 1. |
Inclusion Criteria: * Geographic atrophy in both eyes due to age-related macular degeneration * Visual acuity between 20/40 to 20/320 Exclusion Criteria: * Known allergy to brimonidine * Uncontrolled systemic disease or infection of the eye * Recent eye surgery or injections in the eye * Female p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
400 µg Brimonidine is an investigational ophthalmology treatment being studied for geographic atrophy due to age-related macular degeneration, retinitis pigmentosa, and use in patients undergoing vitrectomy. It is a small molecule delivered as an intravitreal implant for posterior segment eye conditions.
400 µg Brimonidine is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is responsible for the clinical program evaluating this intravitreal implant across retinal conditions including macular degeneration and retinitis pigmentosa.
400 µg Brimonidine is in Phase 2 clinical development. The Phase 2 study has been completed, and the program remains investigational, meaning it has not been approved by the FDA for any indication.
400 µg Brimonidine has been evaluated in three completed clinical trials. NCT00658619 was a Phase 2 sham-controlled study in geographic atrophy due to AMD with 119 patients. NCT01229410 was a Phase 1 pharmacokinetic study in vitrectomy patients, and NCT00661479 was a Phase 1 safety study in retinitis pigmentosa.