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riboflavin · 4 trials · 3 indications
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
| Arm | Type | Description |
|---|---|---|
| riboflavin solution and KXL System | EXPERIMENTAL | Subjects will receive riboflavin solution followed by UVA irradiation for 4 minutes |
| placebo solution and KXL System | PLACEBO_COMPARATOR | Subjects will receive placebo solution followed by UVA irradiation for 4 minutes |
| Corneal Collagen Cross-linking (CXL) Treatment Group | ACTIVE_COMPARATOR | riboflavin ophthalmic solution and UVA irradiation |
| Control Group | SHAM_COMPARATOR | riboflavin ophthalmic solution without UVA irradiation. |
| Name | Type | Description |
|---|---|---|
| riboflavin solution | DRUG | 0.12% riboflavin ophthalmic solution |
| placebo solution | DRUG | 0.0% riboflavin ophthalmic solution |
| KXL System | DEVICE | 30 mW/cm2 |
| riboflavin ophthalmic solution | DRUG | riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) |
| UVA Irradiation | DEVICE | UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes |
Inclusion Criteria: Patients must meet all of the following criteria in order to be enrolled into the trial: 1. Be at least 12 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form...
Riboflavin is an investigational small molecule being studied for corneal collagen cross-linking in progressive keratoconus and ectasia. It is developed by Glaukos Corporation (NYSE: GKOS) and is currently in Phase 3 clinical development. Riboflavin is not FDA approved and remains investigational.
Riboflavin works as a photosensitizer in corneal collagen cross-linking. When activated by ultraviolet light, it induces cross-linking of corneal collagen fibers, which strengthens the cornea. This mechanism is being studied to halt the progression of keratoconus and ectasia.
Riboflavin is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. The company is conducting Phase 3 clinical trials to evaluate riboflavin for the treatment of progressive keratoconus and ectasia.
Riboflavin is in Phase 3 clinical development for the treatment of progressive keratoconus and ectasia. It is an investigational drug and has not been approved by the FDA. Multiple Phase 3 trials have been completed, but the drug remains in clinical development.
Riboflavin has been studied in several completed Phase 3 trials, including NCT00647699 for progressive keratoconus, NCT00674661 for ectasia, and NCT01344187 and NCT01643226 for keratoconus. These trials were conducted in the United States with a total enrollment of 466 patients.
Riboflavin is the drug used in corneal collagen cross-linking (CXL) procedures. The clinical trials listed for riboflavin, such as NCT00647699 and NCT00674661, are titled as corneal collagen cross-linking studies, indicating that riboflavin is the active agent in this procedure.