The Australian Therapeutic Goods Administration (TGA) has approved the use of Aspen Pharmacare’s Eikance 0.01% atropine drop, developed to slow myopia progression in children and young teenagers.
Eleisha Dudson, president of the Cornea and Contact Lens Society (CCLS) in New Zealand, said the TGA approval is great news for myopia management in Australia and New Zealand. “It’s an encouraging step towards the possibility of New Zealand having this or a similar drop available here, which would no doubt increase access and reduce costs to our patients. It may also be the first step to getting different concentrations available under Medsafe, rather than compounded formulations continuing to be the norm.”
In Australia, Eikance (atropine sulfate monohydrate) is now available on prescription for children aged four to 14 when myopia progresses by one or more diopters per year. The TGA approval follows two key randomised, double-blind clinical trials on myopic children aged four to 12 and six to 12 years, who were treated with atropine 0.01% eye drops and followed up for two to five years to assess the drops’ effectiveness and safety.
Aspen Pharmacare New Zealand’s medical manager Anita Jina said that while she didn’t want to comment on specific products, she confirmed the company is currently “exploring opportunities in this country”. Medsafe, however, said there were no applications for regulatory approval of atropine 0.01% eye drops in New Zealand currently under process.
