NDAOPHTHALMICSOLUTION/DROPS1 Generic Approved
Approved
Jul 1993
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 17h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OCUFLOX (ofloxacin) is a topical ophthalmic fluoroquinolone antibiotic approved in 1993 for bacterial eye infections including conjunctivitis and corneal ulcers. It works by inhibiting bacterial DNA gyrase, an essential enzyme for DNA replication and repair, achieving bactericidal activity against a broad spectrum of gram-positive and gram-negative bacteria. The drug is formulated as an eye drop solution with minimal systemic absorption, delivering high local concentrations to ocular tissues.
$6,000Part D
LOE ApproachingDeclining
Product is in late lifecycle with minimal Part D penetration; commercial team likely focused on line extension or market defense rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Quinolone Antimicrobial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
Started Apr 2025
3,291 enrolled
Neisseria Gonorrheae Infection
A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
Started Jun 2023
0Cataract
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
Started Apr 2023
64 enrolled
Healthy Subjects
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
Started Jun 2022
313 enrolled
Acute Lymphoblastic Leukaemia - Category
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
Started Jun 2022
271 enrolled
Tuberculosis, Multidrug-Resistant
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.