JAN 06, 2015
Glaucoma, Pediatric Ophth/Strabismus
Alcon announced that its Travataneye drop solution has been approved in the European Union for pediatric patients with glaucoma or ocular hypertension.
The new approval is based on a 12-week, phase 3, multicenter, double-masked, randomized, parallel-group study (n=152). Travatanwas shown to be safe and effective in children from two months to less than 18 years of age at the same dose as for adults. No data are available for children younger than two months of age.
Reduction in IOP was seen after the second week of treatment and was consistently maintained throughout the 12-week study period, with mean IOP reductions similar in patients treated with travoprost or timolol. The most frequently reported adverse reactions to Travatan in pediatric patients were ocular hyperemia and growth of eyelashes.