ARTG Entry

EIKANCE

ARTG entry for EIKANCE (atropine sulfate), ARTG 408371 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

EIKANCE is a preservative-free, sterile ophthalmic solution containing atropine sulfate available in three strengths: 0.05% (500 micrograms per 1 mL), 0.025% (250 micrograms per 1 mL), and 0.01% (100 micrograms per 1 mL). The eye drops are a clear, colourless solution packed in transparent polyethylene single-dose containers sealed in aluminium laminated foil sachets. EIKANCE is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Treatment to slow the progression of myopia when initiated in children aged from 4 to 14 years.

Dosing overview

EIKANCE eye drops should be administered as one drop to each eye at night. Treatment should be supervised by an eyecare professional, and at least 2 measurements at least 6 months apart are recommended prior to initiation or dosage changes. To minimise the risk of systemic absorption, gentle pressure should be applied to the tear duct for one minute after application. The lowest concentration of atropine eye drops consistent with targeted response should always be used. The 0.05% concentration may be considered the most appropriate initial treatment option in children with a higher risk of myopic progression, while older children at low risk of progression may be initially treated with 0.025% or 0.01% atropine. Dose adjustments, both up and down, may be warranted over the course of treatment based on response and tolerability, with one step dose reductions or increases possible depending on spherical equivalent progression rates.

Key safety warnings

Photophobia was dose related, particularly in the short term, with much higher incidence in the first two weeks of treatment compared to 12 months, when overall incidence was less than 10% for all low concentration atropine. If children experience photophobia or glare, they may be offered photochromic glasses or sunglasses, with photophobia resolved in 72% of children using these aids. Discontinuation of the atropine eye drops may lead to a rebound in myopia, with faster rates of myopia progression observed after cessation, and greater axial elongation at higher concentrations. The mean age of myopia stabilisation is around 15.6 years, with loss of clinical effect and rebound increased myopia progression demonstrated if therapy is ceased prior to this time point, although possible myopia rebound should be considered during discontinuation. Limited clinical evidence is available for the long-term safety of atropine eye drops in children and adolescents, and regular eye health clinical reviews are recommended if long term treatment is planned, including monitoring of anterior segment development, intraocular pressure, retinal health and myopia progression.

Contraindications

EIKANCE eye drops are contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected. If used in glaucoma susceptible patients, an estimation of the depth of the angle of the anterior chamber should be performed prior to the initiation of therapy. EIKANCE is contraindicated in hypersensitivity to any of the ingredients. EIKANCE eye drops should not be used in children less than 4 years of age.

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

EIKANCE 0.01% (atropine sulfate 100 microgram/1 mL) was first listed on the Australian Register of Therapeutic Goods on 13 September 2021. EIKANCE 0.05% and 0.025% strengths were subsequently registered on 17 February 2026.

TGA Public Summary — ARTG 408371