Approval Probability
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Faricimab · 1 trial · 2 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.
| 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 | - |
| 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 |
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 ...
Faricimab is an investigational antibody being studied for the prevention of visual acuity loss due to Radiation Retinopathy. It is administered as intravitreal injections. The drug is currently in Phase 3 clinical development and is not yet approved for this indication.
Faricimab is a -mab, or monoclonal antibody, designed to target specific molecular pathways involved in retinal disease. As an antibody-based therapy, it is intended to interfere with disease processes that contribute to Radiation Retinopathy and visual impairment.
Faricimab is being developed by ANI Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol ANIP. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Radiation Retinopathy.
Faricimab is in Phase 3 clinical development for Radiation Retinopathy. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess its effectiveness.
Faricimab is being studied in a Phase 3 clinical trial with the identifier NCT05844982. This randomized, active-controlled trial compares intravitreal Faricimab injections or fluocinolone acetonide implants versus observation for preventing vision loss due to Radiation Retinopathy. The trial enrolls 600 participants in the United States.
Faricimab is a distinct investigational antibody being tested against an active comparator, fluocinolone acetonide, in a clinical trial. It is not described as being the same as any other drug. The trial is designed to evaluate whether Faricimab offers a benefit compared to observation or the comparator treatment.