ATROPT

What it is

ATROPT is atropine sulfate eye drops, available as a preservative-free, sterile, ophthalmic solution. Three concentrations are registered: 0.05% containing 500 micrograms of atropine sulfate per mL, 0.025% containing 250 micrograms per mL, and 0.01% containing 100 micrograms per mL. The eye drops are supplied as a clear, colourless solution in transparent polyethylene single-dose containers sealed in aluminium laminated foil sachets.

Approved indications

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

Dosing overview

ATROPT eye drops should be administered as one drop to each eye at night. To minimise the risk of systemic absorption, gentle pressure should be applied to the tear duct for one minute after application. Each container is for single use and should be discarded after administration of the dose. The lowest concentration consistent with the targeted response should always be used. The 0.05% concentration may be considered as the most appropriate initial treatment option in children with a higher risk of myopic progression. 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 dose reduction possible if annualised spherical equivalent progression is less than 1.0 D, and concentration reduction possible if progression is less than 0.5 D, particularly in children approaching puberty.

Key safety warnings

Photophobia is 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 is less than 10% for all low concentration atropine and similar to placebo. If children experience photophobia or glare, they may be offered photochromic glasses or sunglasses, with photophobia resolved in 72% of children reporting this effect by using photochromic lenses or sunglasses. Distance and near visual acuity in all atropine treatment groups who continued treatment up to 36 months were not significantly different from baseline, though a significant decrease in visual acuity was noted following cessation of atropine in the washout group. If children experience poor visual acuity, they may be prescribed progressive glasses, with poor near vision acuity improved in 96% of children by the use of multifocal lenses. Discontinuation of the atropine eye drops may lead to a rebound in myopia, with rates of myopia progression after a 12 month washout ranging from −0.56 to −0.68 D and axial elongation greater for higher concentrations. No systemic adverse events have been reported with low concentration atropine drops to date. In clinical trials, the most common adverse events reported were photophobia, blurred vision, poor visual acuity and allergy.

Contraindications

ATROPT 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. ATROPT is also contraindicated in cases of hypersensitivity to any of the ingredients.

PBS listing

ATROPT 10 mg per mL eye drops in 15 mL bottles is listed on the PBS as 1 item with unrestricted access, at an ex-manufacturer price of A$16.50.

Regulatory history

ATROPT received initial ARTG approval on 13 September 2021. The medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.