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Safety Profile
- Drug safety is improved with the delivery system ( carbomer + polyvinyl alcohol ) that reduces systemic
absorption via the nasolacrimal duct thus it provides a 90% decrease in systemic exposure.
- Timogel has no significant change in heart beat rate.
- The nature of the gel provides protection to the ocular surface from drying, so alleviates symptoms of the (Dry eye syndrome) associated with the use of aqueous timolol maleate eye drops like:
burning sensation, foreign body sensation, sensation of pressure.
- Low timolol concentration decreases side effects accompanied with the receptor antagonist.
Plasma levels of timolol
- 90% lower after Timolol 0.1% application.

Chart description
- AUC measured between 10 minutes before and 12 hours after administration.
- After ocular administration of timolol, it's Cmax and AUC values in plasma were about 10 folds lower after timolol 0.1% than after timolol 0.5% solution that indicates that Timogel 0.1% provides a higher safety profile than timolol 0.5% solution.
Heart Beat Rate
- Change from baseline in peak heart rate in an exercise test after a 2 weeks treatment is studied.

Chart description
- Double masked study in 24 healthy volunteers reported a statistically smaller drug induced decrease from baseline in peak heart rate in an exercise test with Timolol 0.1% (mean 4.6 beats/min. than with timolol 0.5% solution twice daily (mean 19 beats/min.)
- Timogel caused no significant change from baseline in heart rate during a test while a statistically significant difference was detected with the aqueous timolol 0.5% solution.
Safety
Profile
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