Zymaxid (gatifloxacin ophthalmic solution)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved May 2010

Specific Treatments:

bacterial conjunctivitis

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General Information

Zymaxid contains the active ingredient gatifloxacin, a fluoroquinolone antibacterial. Gatifloxacin inhibits DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Zymaxid 0.5% solution is specifically indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic Gram-Positive Bacteria:
Staphylococcus aureus; Staphylococcus epidermidis; Streptococcus mitis; Streptococcus oralis; Streptococcus pneumoniae
Aerobic Gram-Negative Bacteria:
Haemophilus influenzae

Zymaxid is supplied as an ophthalmic solution for topical administration into the eye. The recommended dose of the drug in patients 1 year of age and older is one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.

Clinical Results

FDA Approval
The FDA approval of Zymaxid was based on two randomized, double-masked, multicenter clinical trials. Subjects 1-89 years of age were dosed with Zymaxid or placebo for 5 days. Zymaxid solution was clinically superior to placebo on day 6 in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trials demonstrated clinical success (resolution of conjunctival hyperaemia and conjunctival discharge) of 58% for the gatifloxacin-treated groups versus 45% for the placebo-treated groups. Microbiological outcomes for the same clinical trials demonstrated a statistically superior eradication rate for causative pathogens of 90% for gatifloxacin vs. 70% for placebo.

Side Effects

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

  • Worsening of conjunctivitis
  • Eye irritation
  • Dysgeusia
  • Eye pain

Mechanism of Action

Zymaxid contains the active ingredient gatifloxacin, a fluoroquinolone antibacterial. Gatifloxacin inhibits DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Additional Information

For additional information regarding Zymaxid or bacterial conjunctivitis, please visit the Allergan web page.