Sydney’s Dr. Ivan Goldberg has welcomed news that the European Commission has approved the use of Travatan (travoprost) in minors to reduce intraocular pressure.
The Eye Drops Solution was granted an 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. Prior to this, the Alcon product was 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.
Paediatric glaucoma is responsible for 5 per cent 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.
In a statement released by Alcon’s parent company Novartis, Professor Stefano Gandolfi, MD, Head of Eye Clinic, University of Parma, Italy said, “Paediatric 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. 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.”
Speaking of the EC approval, Dr. Goldberg said, “management of childhood glaucomas is challenging and the consequences of management are life-long. Any additions to our armamentarium are valuable and important.
“It is particularly encouraging to see controlled prospective evidence of the highest level that demonstrates equipotency of this anti-glaucoma agent in infants and children compared with adults, where it has been used effectively for over a decade.
“It would be most helpful for patients and clinicians alike for this extension of the indications for use of travoprost and other prostaglandin agents to apply in Australia.”
The EU approval was based on a 12-week, Phase III, multicenter, double-masked, randomised, 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 paediatric patients were ocular hyperemia and growth of eyelashes.
According to the statement released by Alcon, 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 per cent over the course of a day.
