Approval Probability
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ML Risk
Label indication BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans* CDC coryneform group G Corynebacterium pseudodiphtheriticum* Corynebacterium striatum* Haemophilus influenzae Moraxella catarrhalis* Moraxella lacunata* Pseudomonas aeruginosa* Staphylococcus aureus Staphylococcus epidermidis… FDA label
Also known as besifloxacin, Besivance, BOL-303224, BOL-303224-A, Besifloxacin Ophthalmic Suspension 0.6%
ISV-403 · 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...
ISV-403 is an investigational small molecule being developed for the treatment of bacterial conjunctivitis, including acute bacterial conjunctivitis. It is administered as an ophthalmic formulation. The drug is currently in clinical development and has not been approved by regulatory authorities.
ISV-403 is being developed by Bausch + Lomb Corporation, which trades under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of ISV-403 for the treatment of bacterial conjunctivitis.
ISV-403 is in Phase 3 clinical development for the treatment of acute bacterial conjunctivitis. A Phase 3 trial has been completed, and the drug remains investigational. It is not yet approved by the FDA or other regulatory agencies.
ISV-403 has been studied in two completed clinical trials. NCT00347932 was a Phase 3 study with 957 participants evaluating the safety and efficacy of 0.6% ISV-403 in acute bacterial conjunctivitis. NCT00622908 was a Phase 2 study with 270 participants assessing clinical and microbial efficacy in bacterial conjunctivitis.
ISV-403 is a distinct investigational drug being developed by Bausch + Lomb. No alternative names have been reported for this compound. It is being studied specifically for its potential role in treating bacterial conjunctivitis, but it is not yet commercially available.