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Also known as fluocinolone acetonide intravitreal implant
fluocinolone acetonide intravitreal · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Fluocinolone acetonide 0.59 mg | EXPERIMENTAL | 0.59 mg fluocinolone acetonide intravitreal implant |
| Fluocinolone acetonide 2.1 mg | EXPERIMENTAL | 2.1 mg fluocinolone acetonide intravitreal implant |
| Laser photocoagulation | ACTIVE_COMPARATOR | standard of care laser photocoagulation |
| Fluocinolone acetonide | EXPERIMENTAL | Intravitreal fluocinolone acetonide implant |
| Standard care | ACTIVE_COMPARATOR | Standard of Care |
| Fluocinolone acetonide 0.59mg | EXPERIMENTAL | Fluocinolone acetonide ocular implant 0.59mg |
| Fluocinolone acetonide 2.1mg | EXPERIMENTAL | Fluocinolone acetonide ocular implant 2.1mg |
| No intervention | NO_INTERVENTION | Fellow eye |
| Name | Type | Description |
|---|---|---|
| 0.59 mg fluocinolone acetonide intravitreal implant | DRUG | 0.59 mg |
| 2.1 mg fluocinolone acetonide intravitreal implant | DRUG | 2.1 mg |
| standard of care laser photocoagulation | PROCEDURE | standard of care laser photocoagulation |
| fluocinolone acetonide intravitreal implant | DRUG | surgical intravitreal implant of fluocinolone acetonide |
| corticosteroids and immunosuppressants | DRUG | Systemic corticosteroids alone or combined with immunosuppressants |
| Fluocinolone acetonide 2.1mg | DRUG | Fluocinolone acetonide ocular implant 2.1mg |
Inclusion Criteria: * Subjects with type 1 or 2 diabetes. * Subjects with clinically significant macular edema as defined by the ETDRS. * A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart. * Subjects with...
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 intravitreal is studied for diabetic macular edema, non-infectious uveitis, and noninfectious posterior uveitis. It is an intravitreal implant placed inside the eye to deliver the corticosteroid fluocinolone acetonide directly to the retina and surrounding tissue. It is being developed by Bausch + Lomb Corporation.
Bausch + Lomb Corporation, which trades under the ticker BLCO, is the developer of fluocinolone acetonide intravitreal. The company has sponsored the clinical trial program evaluating the implant in diabetic macular edema and non-infectious uveitis, including noninfectious posterior uveitis.
Fluocinolone acetonide intravitreal is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for the studied eye conditions. The Phase 2 program has been completed, and the trials enrolled a combined total of 278 participants across the studied indications.
The Phase 2 program includes NCT00576459 in diabetic macular edema, NCT00468871 in non-infectious uveitis, and NCT00407082 in noninfectious posterior uveitis. All three trials are completed. NCT00407082 was the largest, enrolling 278 patients in the United States, while NCT00576459 enrolled 40 patients in China and India.
The Phase 2 trials were randomized and active-controlled, comparing the fluocinolone acetonide intravitreal implant against standardized therapy. The studies enrolled adults and children as young as 6 years, included both sexes, and did not enroll healthy volunteers. The program covered diabetic macular edema and non-infectious uveitis, including noninfectious posterior uveitis.