Source: DGNews  |  Posted 8 years ago

By Deanna M Green, PhD

ANAHEIM, CA -- November 19, 2003 -- Moxifloxacin treatment is well tolerated and successfully cures more than 80% of neonates with bacterial conjunctivitis, according to findings presented here November 16th at the 2003 Annual Meeting of the American Academy of Ophthalmology.

Conjunctivitis is the most common infection found during the first month of life, occurring in 2-12% of all newborns. Unfortunately, there are currently no topical ophthalmic antibiotics with FDA approval for children under 1 month of age.

Vigamox (moxifloxacin HCl ophthalmic solution, 0.5% as base) is a fourth-generation fluoroquinolone that is effective against both gram-negative and gram-positive bacteria. It was approved in Spring 2002 for the treatment of bacterial conjunctivitis in patients as young as 3 years of age. Whether Vigamox is effective in younger patients is still under investigation.

Robert L Treft, MD, of the Mountain View Eye Center, Layton, Utah, United States, and colleagues in the Vigamox/Ciloxan Study Group evaluated the safety and efficacy of Vigamox in the treatment of bacterial conjunctivitis in neonates.

The study included 209 patients between the ages of 2 and 31 days who had presumed bacterial conjunctivitis based on evidence of mild bulbar conjunctival injection or discharge. Patients were randomised to receive either Vigamox 0.5% or Ciloxan 0.3% three times a day for four days. Cultures were obtained at the start of treatment and on Day 9 (test-of-cure visit).

The pathogen was eradicated in 92% of culture-positive patients treated with Vigamox. Furthermore, 58% were clinically cured by the end of treatment, and 80% were clinically cured by Day 9.

More than half of the culture-positive patients given Vigamox responded by Day 2 of treatment, and 80% showed clinical improvement by the end of treatment (Day 4). The effect was sustained, as 83% showed clinical improvement at Day 9.

Few ocular adverse events occurred that were related to treatment. There were two cases of eye hyperaemia in the Vigamox-treated group and one in the Ciloxan group. Moreover, one case of lid oedema occurred in the Ciloxan group.

Notably, 68% of patients were found to be culture positive at the start of treatment, and the most common pathogen detected was Staphylococcus epidermis.

"Vigamox 0.5%, a fourth-generation fluoroquinolone, was found to be well tolerated, with clinical improvement at Day 4 of 80%," concluded Dr. Treft. "Based on this study, it appears that Vigamox can be used to treat bacterial conjunctivitis in patients of all ages."

[Study title: Vigamox Ophthalmic Solution (A New Fourth-Generation Fluoroquinolone) for the Treatment of Bacterial Conjunctivitis in Neonates. Abstract PO014]