Pharmacotherapeutic group: Ophthalmologicals / Other anti-infectives ATC code: S01AX05
Bibrocathol is a bismuth-containing substance with antiseptic, astringent, and mucosal and wound secretion-inhibiting properties. Its mechanism of action is attributed to its phenolic molecular structure consisting of tetrabromopyrocatechol and bismuth hydroxide, which causes protein precipitation and contraction of the superficial tissue layers. These effects lead to the formation of a protective membrane against pathogenic invasion and to non-specific inhibition of inflammation and secretion.
The efficacy and safety of bibrocathol in the form of a 2% eye ointment for the treatment of blepharitis were investigated in two double-blind, placebo-controlled, randomised studies in patients with moderate blepharitis or blepharoconjunctivitis whose condition did not require antibiotic treatment. A total of 200 patients were treated for 2 weeks with application 3 times daily, and a total of 196 patients were treated for an average of 10 days with application 3 times daily, respectively. In the first study, the primary endpoint was the assessor-evaluated mean change in a composite score of five disease signs (eyelid oedema, erythema, signs of secretion, hyperaemia, and meibomian gland induration) after two weeks of treatment. The maximum score was 20. The primary endpoint of the second study was similar but evaluated a composite of only four of the aforementioned signs (excluding hyperaemia), with a maximum score of 16. Both studies met their criteria: in the first study, the Least Square Mean (LSM) change from baseline (baseline score approximately 14) to day 15 was -8.621 in the bibrocathol group and -5.996 in the placebo group (LSM difference 2.625 [95% CI: -3.360; -1.890], p<0.0001). In the second study, the baseline score was 10.5 points and the primary outcome difference was -2.32 points [95% CI: -2.84; -1.80], p<0.0001. In both studies, the primary endpoints were supported by secondary outcome results in the form of patient assessments regarding relief of ocular symptoms. Both studies confirmed the efficacy and safety of bibrocathol in the form of a 2% eye ointment.
⚠️ Warnings
Wool fat may cause local skin reactions (e.g. contact dermatitis). Contact lenses should not be worn during treatment with Posiforlid.