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Loteprednol and tobramycin
Loteprednol and tobramycin is a combination drug developed by Bausch & Lomb Incorporated for the treatment of bacterial conjunctivitis. The drug combines an anti-inflammatory corticosteroid, loteprednol, with an antibiotic, tobramycin, to address both the infection and inflammation associated with the condition. Despite its effectiveness, the drug does not have an FDA label, which may limit its use in certain clinical settings. Common side effects include eye irritation, increased intraocular pressure, and corneal edema. The drug's dual-action mechanism makes it a valuable option for patients with bacterial conjunctivitis, but its lack of FDA approval may impact its commercial potential.
At a glance
| Generic name | Loteprednol and tobramycin |
|---|---|
| Also known as | Zylet |
| Sponsor | Bausch & Lomb Incorporated |
| Drug class | Corticosteroid/aminoglycoside combination |
| Target | Inflammatory mediators and bacterial protein synthesis |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
Pipeline indications
Common side effects
- Injection (conjunctival)
- Superficial punctate keratitis
- Headache
- Increased intraocular pressure
- Burning and stinging upon instillation
- Vision disorders
- Discharge
- Itching
- Lacrimation disorder
- Photophobia
- Corneal deposits
- Ocular discomfort
Serious adverse events
- Optic nerve damage
- Visual acuity and field defects
- Posterior subcapsular cataract formation
- Delayed wound healing
- Secondary ocular infection
- Globe perforation
- Fungal corneal infection
- Persistent corneal ulceration
- Secondary bacterial ocular infection
Key clinical trials
- Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial (PHASE1)
- A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis (PHASE4)
- Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis (PHASE4)
- Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis (PHASE4)
- Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis (PHASE3)
- Zylet vs TobraDex in Blepharokeratoconjunctivitis (PHASE4)
- Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex (PHASE4)
- Pediatric Zylet Safety and Efficacy Study (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US12345678 |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Loteprednol and tobramycin CI brief — competitive landscape report
- Loteprednol and tobramycin updates RSS · CI watch RSS
- Bausch & Lomb Incorporated portfolio CI