Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TOBRADEX ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. FDA label
Tobradex ST · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Tobradex ST | EXPERIMENTAL | tobramycin 0.3%, dexamethasone 0.05% |
| Azasite | ACTIVE_COMPARATOR | azithromycin 1% |
| Name | Type | Description |
|---|---|---|
| Tobradex ST | DRUG | tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days |
| Azasite | DRUG | azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days |
Inclusion Criteria: * Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye * Have a minimum global score (the total signs and symptoms score) of 5 in t...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 1 | PHASE4 | GLK-321 |
Tobradex ST is an investigational small molecule being developed for the treatment of moderate to severe chronic blepharitis, an inflammatory condition of the eyelids. It is administered as an ophthalmic formulation. The drug is currently in clinical development and has not been approved by regulatory authorities.
Tobradex ST is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company specializing in eye care products, including treatments for various ophthalmic conditions.
Tobradex ST is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled study. The drug remains investigational and is not yet approved for commercial use. Further regulatory review and potential additional studies would be required before market approval.
Tobradex ST has been evaluated in one completed Phase 3 clinical trial, registered as NCT01102244. This study assessed the clinical efficacy and safety of Tobradex ST compared to Azasite in 122 participants with moderate to severe chronic blepharitis. The trial was conducted in the United States and enrolled adults aged 18 years and older.
Tobradex ST is a distinct formulation from standard Tobradex, though both are developed by Alcon. The 'ST' designation indicates a different formulation, which in this case is being studied specifically for chronic blepharitis. The Phase 3 trial compared Tobradex ST against Azasite, not against standard Tobradex.