Azyter: first macrolide preparation for ocular use

on the 29 July 2011

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.