Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ISV-403, Besifloxacin
BOL-303224-A · 6 trials · 4 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 and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Bacterial species eradication of baseline bacterial infection
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
| Arm | Type | Description |
|---|---|---|
| ISV-403 | EXPERIMENTAL | 0.6% ISV-403 ophthalmic suspension |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of ISV-403 ophthalmic suspension |
| Moxifloxacin solution | ACTIVE_COMPARATOR | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
| Besifloxacin Suspension | EXPERIMENTAL | Besifloxacin hydrochloride ophthalmic suspension 0.6% |
| Besifloxacin | EXPERIMENTAL | 0.6% ophthalmic suspension |
| Moxifloxacin | ACTIVE_COMPARATOR | Vigamox (moxifloxacin ophthalmic solution, 0.5%) |
| Gatifloxacin | ACTIVE_COMPARATOR | Zymar (gatifloxacin ophthalmic solution, 0.3%) |
| BOL-303224-A | EXPERIMENTAL | Systemic exposure of BOL-303224-A following single and multiple topical doses |
| 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. |
| Besifloxacin | DRUG | Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days |
| Moxifloxacin solution | DRUG | Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days. |
| Vehicle (Placebo) | DRUG | Vehicle administered to the study eye two times a day for three days. |
| Besifloxacin hydrochloride | DRUG | Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
| moxifloxacin hydrochloride | DRUG | Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
| gatifloxacin | DRUG | Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
| BOL-303224-A | DRUG | 1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6). |
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...
BOL-303224-A is an investigational small molecule being developed for bacterial conjunctivitis, an eye infection. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its systemic pharmacokinetics in patients with this condition.
BOL-303224-A is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker BLCO. The company is conducting clinical research on this investigational drug for bacterial conjunctivitis.
BOL-303224-A is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still in the early stages of clinical testing for bacterial conjunctivitis.
BOL-303224-A has one completed Phase 1 clinical trial registered as NCT00407589, titled "Systemic Pharmacokinetics of BOL-303224-A." The trial enrolled 24 participants in the United States and studied the drug's systemic exposure in patients with bacterial conjunctivitis.
No, BOL-303224-A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for bacterial conjunctivitis. A Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval.