Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as fluocinolone acetonide
Fluocinolone Acetonide/Medidur · 5 trials · 4 indications
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
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.
Visual acuity is measured using ETDRS charts at 4 meters.
| Arm | Type | Description |
|---|---|---|
| Intravitreal faricimab | ACTIVE_COMPARATOR | Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial. |
| Fluocinolone Acetonide Intravitreal Implants | ACTIVE_COMPARATOR | Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle |
| Observation | NO_INTERVENTION | - |
| Fluocinolone Acetonide | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Faricimab | DRUG | 6.0 mg intravitreal injection at randomization and every 3 months |
| fluocinolone acetonide | DRUG | 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months |
| Standard of care laser photocoagulation | PROCEDURE | Laser photocoagulation |
| Fluocinolone Acetonide/Medidur | DRUG | 0.2 ug/day implant |
Key Inclusion Criteria * Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy * Absence of unrelated cause of visual loss * Baseline visual acuity ≥ 34 letters (20/200 Snellen equivalent or better) * Posterior tumor margin \>0 mm from the center of ...
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/Medidur is an investigational small molecule therapy being developed by ANI Pharmaceuticals, Inc. (ticker: ANIP) for ophthalmic conditions. It is designed for intravitreal administration and is being studied in age related macular degeneration, diabetic macular edema, and radiation retinopathy. The program is in Phase 2 development.
Fluocinolone Acetonide/Medidur is being studied for the treatment of age related macular degeneration, diabetic macular edema, and radiation retinopathy. These are retinal conditions that can lead to visual impairment. The drug is not yet approved and remains in clinical development.
Fluocinolone Acetonide/Medidur is being developed by ANI Pharmaceuticals, Inc., which trades under the ticker ANIP. The company is the sponsor of the clinical program evaluating this therapy in ophthalmology indications.
Fluocinolone Acetonide/Medidur is in Phase 2 development. It is an investigational therapy and has not been approved by the FDA. The program includes completed Phase 2 and Phase 3 trials as well as one ongoing Phase 3 study.
Fluocinolone Acetonide/Medidur has been evaluated in several clinical trials. The ongoing study is NCT05844982, a Phase 3 trial in radiation retinopathy. Completed trials include NCT01304706 and NCT00490815 in diabetic macular edema, and NCT00605423, a Phase 2 pilot in age related macular degeneration.
Yes, Fluocinolone Acetonide/Medidur is also known as fluocinolone acetonide. Medidur refers to the sustained-release delivery formulation of fluocinolone acetonide. Searches for either name refer to the same investigational ophthalmic asset developed by ANI Pharmaceuticals.