Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test Article A · 1 trial · 1 indication
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
| Arm | Type | Description |
|---|---|---|
| Epithelium-on CXL Treatment Group | EXPERIMENTAL | Study eye receives Test Article A, Test Article B, and exposed to cross-linking dose of UVA light generated by the KXL medical device system |
| Sham Treatment/Control Group | SHAM_COMPARATOR | Sham eye receives Placebo and and exposed to mock dose of UVA light generated by the KXL medical device system |
| Name | Type | Description |
|---|---|---|
| Test Article A | DRUG | Riboflavin Ophthalmic Solution A |
| Test Article B | DRUG | Riboflavin Ophthalmic Solution B |
| Placebo | DRUG | Placebo Vehicle of Test Article |
| KXL medical device system | DEVICE | Mock UVA light source |
Inclusion Criteria: 1. Be between 12 and 55 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as havi...
Test Article A is an investigational small molecule being developed for progressive keratoconus, a condition that thins and bulges the cornea. It is administered as an epi-on corneal cross-linking treatment, meaning it is applied without removing the corneal epithelium. The drug is currently in Phase 3 clinical development.
Test Article A is a small molecule used in corneal cross-linking for progressive keratoconus. The treatment is designed to strengthen the corneal tissue to halt the progression of the disease. The specific molecular target of Test Article A has not been disclosed.
Test Article A is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. Glaukos is focused on ophthalmology and is advancing this treatment for progressive keratoconus.
Test Article A is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial for Test Article A has been completed, and the drug is being evaluated for safety and efficacy in patients with progressive keratoconus.
Test Article A has one completed Phase 3 clinical trial, identified as NCT03442751. This study, titled 'Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus,' enrolled 201 participants in the United States. The trial was randomized, double-blind, and sham-controlled.
Test Article A is the drug being evaluated in an epi-on corneal cross-linking procedure. Epi-on refers to the technique of applying the treatment without removing the corneal epithelium. The drug itself is not the procedure but is the active agent used in this cross-linking approach for progressive keratoconus.