Azyter: first macrolide preparation for ocular use

Azithromycin is now available as eye drops for the treatment of purulent bacterial or trachomatous conjunctivitis. Azyter (azithromycin) is presented in single-dose units containing 15mg/g of the active ingredient. Administered twice daily for 3 days, it has a shorter dose regimen than many other ophthalmic anti-infectives. As a macrolide, azithromycin has a broad spectrum of activity. It is effective against the majority of bacteria responsible for common eye infections, including Gram-positive cocci (eg, Staphylococcus aureus), Gram-negative species (eg, Haemophilus influenzae) and intracellular pathogens (eg, Chlamydia trachomatis).

In a randomised, double-blind study in 670 children aged 1–10 years with conjunctivitis caused by Chlamydia trachomatis, the 60-day clinical cure rate achieved with azithromycin eye drops was non-inferior to that achieved with an oral azithromycin dose (96.3% vs 96.6%).

Azithromycin eye drops were also evaluated in a randomised, investigator-blinded study in adults and children with purulent bacterial conjunctivitis. Participants received azithromycin drops twice daily for 3 days or tobramycin 0.3% drops every 2 hours for 2 days then 4 times daily for 5 days. The clinical cure rate for azithromycin at day 9 in the per-protocol analysis (n=471) was non-inferior to that of tobramycin (87.8% vs 89.4%), with a similar microbiological resolution rate.

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Further Information: Spectrum Thea Pharma