Alcon, the global leader in eye care and second-largest division of Novartis, announced that its treatment for patients with glaucoma, Travatan (40µg/mL travoprost) eye drops solution, has been granted an additional indication by the European Commission to decrease elevated intraocular pressure (IOP) in paediatric patients, aged two months to less than 18 years, with ocular hypertension or paediatric glaucoma.
Travatan is currently indicated to decrease elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma.
Glaucoma is a progressive eye disease that damages the optic nerve, resulting in gradual, irreversible loss of vision, and eventually blindness if left untreated or not adequately managed. Elevated eye pressure, or IOP, is considered the main risk factor for glaucoma.
"Pediatric glaucoma affects only a small number of children worldwide, so there is little data available about how to manage this sight-threatening disease in paediatric patients," said Professor Stefano Gandolfi, MD, Head of Eye Clinic, University of Parma, Italy. "The Travatan approval for this additional indication means that ophthalmologists now have a new medicine to prescribe to help children and adolescents control their IOP level every day."
Paediatric glaucoma is responsible for 5% of childhood blindness worldwide. Patients suffering from glaucoma have no cure and, if vision is lost, it cannot be restored. Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops, or in the most severe cases, with surgery.
"We are pleased to receive the new EU paediatric indication of Travatan, which further strengthens Alcon's globally-leading glaucoma portfolio. The addition of this indication demonstrates Alcon's long-term commitment and dedication to alleviating the patient burden of this sight-threatening disease," said Jeff George, Global Head of Alcon.
The EU approval is based on a 12-week, phase III, multicenter, double-masked, randomized, parallel-group study (n=152). The primary efficacy endpoint was the IOP change from baseline at Week 12 of the study. The effect on IOP was seen after the second week of treatment and was consistently maintained throughout the 12-week study period. Mean IOP reductions in the travoprost and timolol groups were similar. Travatran was shown to be safe and effective for use 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 below the age of two months. In the clinical study, the most frequently reported adverse drug reactions in pediatric patients were ocular hyperemia and growth of eyelashes.
Travatan, preserved with Polyquad, is the first and only, multi-dose prostaglandin analogue without benzalkonium chloride (BAK) approved in the EU, In previous clinical studies in adult patients, Travatan showed strong IOP-lowering efficacy, decreasing IOP by 30% over the course of a day.
Alcon provides a broad spectrum of pharmaceutical and surgical treatment solutions to address the needs of patients at all stages of glaucoma management and care. As a world leader in treatments for glaucoma patients, Alcon is committed to developing solutions for unmet medical needs. Alcon offers a broad range of pharmaceutical treatment options for patients with glaucoma to help lower elevated IOP: Simbrinza, Travatan, Duotrav, Azarga, Azopt and Izba.