Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISV-403 · 2 trials · 2 indications
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Bacterial species eradication of baseline bacterial infection
| Arm | Type | Description |
|---|---|---|
| ISV-403 | EXPERIMENTAL | 0.6% ISV-403 ophthalmic suspension |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of ISV-403 ophthalmic suspension |
| Name | Type | Description |
|---|---|---|
| ISV-403 | DRUG | Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days. |
| Vehicle | DRUG | Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days. |
Inclusion Criteria: * Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. * Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test. Exclusion Criteria: * Pre...
ISV-403 is an investigational small molecule being developed for the treatment of bacterial conjunctivitis, including acute bacterial conjunctivitis. It is an ophthalmic drug candidate studied in clinical trials for this eye infection.
ISV-403 is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
ISV-403 has completed a Phase 3 clinical trial for acute bacterial conjunctivitis. It is an investigational drug and has not been approved by the FDA. The Phase 3 study was completed, and the drug remains in clinical development.
ISV-403 has been studied in two completed clinical trials. NCT00347932 was a Phase 3 study with 957 participants evaluating 0.6% ISV-403 for acute bacterial conjunctivitis. NCT00622908 was a Phase 2 study with 270 participants assessing clinical and microbial efficacy in bacterial conjunctivitis.
ISV-403 and ISV403 refer to the same drug candidate. The clinical trial NCT00622908 uses the name ISV403, while other studies use ISV-403. Both names denote the same investigational ophthalmic treatment for bacterial conjunctivitis.