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Label indication RETISERT ® is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT is a corticosteroid indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. (1) FDA label
fluocinolone acetonide · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Fluocinolone acetonide | EXPERIMENTAL | Fluocinolone acetonide intravitreal implant |
| Standard of Care | ACTIVE_COMPARATOR | Standard of care |
| Vein Occlusion Eye | EXPERIMENTAL | Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device |
| Name | Type | Description |
|---|---|---|
| fluocinolone acetonide | DRUG | fluocinolone acetonide 0.59 mg intravitreal implant |
| Standard of Care | PROCEDURE | Repeat macular grid laser or observation |
| fluocinolone acetonide (Retisert Implant) | DEVICE | sustained release device consisting of 0.59 mg of fluocinolone acetonide |
Inclusion Criteria: * Males and nonpregnant females at least 18 years of age, with DME in the study eye * Edema must involve fixation and be at least 1 disc area in size * Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye * The study eye must have received at least one macular laser tr...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
Fluocinolone acetonide is being developed for the treatment of diabetic macular edema and retinal vein occlusion, both retinal conditions that can impair vision. It is an intravitreal implant formulation studied in these ophthalmology indications. It is investigational and has not been approved for these uses.
Fluocinolone acetonide is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is the sponsor of the clinical program evaluating the intravitreal implant in retinal disease.
Fluocinolone acetonide is in Phase 2 clinical development. The Phase 2 study was conducted in diabetic macular edema, and a separate early Phase 1 study was run in retinal vein occlusion. Both trials have been completed, and no trials are currently active.
Two completed trials are registered for fluocinolone acetonide. NCT00502541 was a Phase 2 study of the intravitreal implant in diabetic macular edema with 196 patients. NCT00636493 was an early Phase 1 study of the implant in retinal vein occlusion with 30 patients in the United States.
The Phase 2 trial NCT00502541 in diabetic macular edema enrolled 196 patients and was randomized, double blind, and active controlled. Participants were 18 years or older, and the study enrolled both sexes. The trial has been completed.