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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
Fluocinolone acetonide is an investigational small molecule being studied for diabetic macular edema and retinal vein occlusion. It is administered as an intravitreal implant. The drug is in clinical development and is not approved for these indications.
Fluocinolone acetonide is a corticosteroid that works by reducing inflammation in the eye. It is delivered via an intravitreal implant to treat conditions like diabetic macular edema and retinal vein occlusion. The drug's anti-inflammatory action is the basis for its potential therapeutic effect.
Fluocinolone acetonide is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for ophthalmic conditions.
Fluocinolone acetonide is in Phase 2 clinical development for diabetic macular edema. A separate early Phase 1 trial has been completed for retinal vein occlusion. The drug remains investigational and has not received FDA approval.
Fluocinolone acetonide has been studied in two completed trials. NCT00502541 was a Phase 2 study in 196 patients with diabetic macular edema. NCT00636493 was an early Phase 1 trial in 30 patients with retinal vein occlusion in the United States.
Fluocinolone acetonide is a specific corticosteroid used in intravitreal implants. It is distinct from other corticosteroid implants, such as those containing dexamethasone or triamcinolone. The drug's unique formulation and delivery method differentiate it from other treatments in this class.