General Information

Ocuflox (ofloxacin ophthalmic solution) 0.3% is a fluorinated carboxyquinolone anti-infective.

Ocuflox is specifically indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

Conjunctivitis:

• Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae
• Gram-negative bacteria: Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa

Corneal Ulcers:

• Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae
• Gram-negative bacteria: Pseudomonas aeruginosa, Serratia marcescens
• Anaerobic species: Propionibacterium acne

Ocuflox is for topical ophthalmic use. The recommended dosage regimens are:

The treatment of bacterial conjunctivitis: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily.

The treatment of bacterial corneal ulcer: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake. Days 7 to 9 through treatment completion Instill one to two drops, four times daily

Mechanism of Action

Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA.

Side Effects

Adverse effects associated with the use of Ocuflox may include, but are not limited to, the following:

• transient ocular burning
• discomfort

Clinical Trial Results

Conjunctivitis

In a randomized, double-masked, multicenter clinical trial, Ocuflox ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

Corneal Ulcers

In a randomized, double-masked, multi-center clinical trial of 140 subjects with positive cultures, Ocuflox ophthalmic solution treated subjects had an overall clinical success rate (complete re-epithelialization and no progression of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and 10% cefazolin solutions. The median time to clinical success was 11 days for the ofloxacin treated group and 10 days for the fortified treatment group.