Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fluocinolone acetonide · 3 trials · 1 indication
This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).
This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
| Arm | Type | Description |
|---|---|---|
| Fluocinolone Acetonide | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fluocinolone Acetonide | DRUG | 0.2 μg/day |
| Standard of care laser photocoagulation | PROCEDURE | Laser photocoagulation |
Inclusion Criteria: 1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies. 2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN. 3. Ability and willingness to comp...
| 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/Medidur is an investigational small molecule being studied for Age Related Macular Degeneration and Diabetic Macular Edema. It is in Phase 2 clinical development for these ophthalmology indications. The drug is not approved and remains under investigation.
ANI Pharmaceuticals, Inc. (ticker: ANIP) is developing Fluocinolone Acetonide/Medidur. The company is conducting clinical trials for the drug in the United States across multiple studies.
Fluocinolone Acetonide/Medidur is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Age Related Macular Degeneration and Diabetic Macular Edema.
Fluocinolone Acetonide/Medidur has completed three clinical trials. These include NCT00344968 and NCT00490815 for Diabetic Macular Edema, and NCT00605423 for Age Related Macular Degeneration. All trials were completed in the United States with a total enrollment of 1113 participants.
Yes, Fluocinolone Acetonide/Medidur is also known as fluocinolone acetonide. The drug is being developed by ANI Pharmaceuticals, Inc. under this alternative name in clinical trials for eye conditions.