Alcon, the worldwide pharmaceutical pioneer in eye treatments and second-biggest Novartis branch reported that Travatan, an eye drop treatment created for those suffering from glaucoma, has been allowed an with some extra provisions by the European Commission. Basically the drug is now extended to pediatric patients aged between two months and eighteen years old. Travatan treats ocular pressure(IOP), a symptom of pediatric glaucoma or ocular hypertension.
So far, the medicine has been proved to reduce hoisted intraocular pressure in grown-up patients with visual hypertension or open-angle glaucoma. Glaucoma is a dynamic eye illness that gradually destroys the optic nerve. The disease leads to progressive and permanent sight loss up to the point of blindness if adequate treatment is not provided. IOP is seen as the most important risk element for glaucoma.
Professor Stefano Gandolfi, MD, Head of the Eye Clinic at University of Parma, Italy, stated that approving Travatan for children now allows specialists to prescribe the drug so children and youngsters have an alternative to manage their IOP level daily.
About of 5% of blind children in the world attained this condition because of pediatric glaucoma. There is no cure for glaucoma and once the eyesight is lost, it can never be recovered.
Lifted IOP is the main known changeable risk element for glaucoma and can normally be kept under control with every day eye drops, or in critical serious cases, with a medical intervention.
Jeff George, Global Head of Alcon stated that his company is satisfied to get the new European pediatric evidence of Travatan. He considers the approval will further reinforce Alcon`s all inclusive glaucoma collection of treatments. He also added that the EU decision is recognition of the company’s engagement to treat this blindness- threatening medical condition.
The EU endorsement came after a 12-week, Phase III, group study where patients were randomly selected in two parallel groups. The main results of the study showed that after the second week of treatment the drug managed to constantly reduce the ocular pressure. The medicine showed no-adult efficacy even if taken in the same dosage as grown-ups. The data is only applicable to children above two months old. In the clinical study, the recurrent side effects in response to the drug were visual hyperemia and increase of eyelashes.
Travatan is the first and only medicine of its kind allowed in the European Union. The drug does not contain benzalkonium chloride (BAK) though it is a multiple- dosage prostaglandin analogue. Adult clinical trials with the drug indicated a solid IOP drop by 30% during a day.
Image Source: Alcon.com