The US Food and Drug Administration (FDA) has approved besifloxacin 0.6% ophthalmic suspension for the treatment of bacterial conjunctivitis caused by susceptible isolates of CDC coryneform group G, Corynebacterium pseudodiphtheriticum , Corynebacterium striatum , Haemophilus influenza , Moraxella lacunata , Staphylococcus aureus , Staphylococcus epidermidis , Staphylococcus hominis , Staphylococcus lugdunensis , Streptococcus mitis group, Streptococcus oralis , Streptococcus pneumonia , and Streptococcus salivarius bacteria.

Approval of this topical fluoroquinolone was based primarily on data from a randomized, double-blind, multicenter clinical trial of patients aged 1 to 98 years, showing that use of besifloxacin was significantly more effective for achieving clinical resolution of bacterial conjunctivitis symptoms than the non medicated vehicle alone (45% vs. 33%; 95% confidence interval, 3% – 22%). Microbiologic outcomes also revealed a statistically significant increase in eradication rate for causative pathogens (91% vs. 60%).

Source: www.medscape.com Accessed on 19/11/2009

 

The U.S. Food and Drug Administration have approved ganciclovir ophthalmic gel 0.15% as a topical treatment for acute herpetic keratitis.

The FDA's action was based on data from an open-label, randomized clinical trial (n = 164) and 3 randomized, single-blind studies (n = 213) conducted in Europe and Asia, showing that ganciclovir 0.15% ophthalmic gel was non inferior to acyclovir 3% ophthalmic ointment for achieving clinical resolution of dendritic ulcers at day 7 (77% vs. 72% and 72% vs. 69%, respectively). Both are standard-of-care therapies outside of the United States and selectively target herpes simplex virus DNA replication.

The recommended dosing regimen for ganciclovir ophthalmic gel is 1 drop instilled in the affected eye 5 times daily until the ulcer heals, and then 1 drop 3 times daily for 7 days. Adverse events most commonly reported in clinical trials included blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Source: www.medscape.com Accessed on 19/11/2009

 

The FDA has approved bepotastine besilate 1.5% ophthalmic solution for the twice-daily treatment of ocular itching associated with allergic conjunctivitis in patients aged 2 years and older.

Approval of the histamine H1 receptor antagonist was based primarily on data from 2 phase 3 double-blind, conjunctival allergen challenge studies (n = 237) showing that bepotastine significantly decreased ocular itching relative to use of the vehicle alone at 15 minutes and 8 hours post dose.

Adverse events reported in 2% to 5% of treated patients included eye irritation, headache, and nasopharyngitis.

Source: www.medscape.com Accessed on 19/11/2009