Atropine sulfate FGK
Opinion
EMA has issued an opinion on this medicine
atropine
Medicine
Human
Opinion
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Atropine sulfate FGK. The medicine was intended for the treatment of myopia (short-sightedness) in children aged 6 to 10 years.
The Agency issued its opinion after re-examination on 18 September 2025. The Agency had issued its initial opinion on 22 May 2025. The company that applied for authorisation of Atropine sulfate FGK is FGK Representative Service GmbH.
Atropine sulfate FGK was developed as a medicine to slow the progression (worsening) of myopia in children aged 6 to 10 years with myopia between -0.50 and -6.00 dioptres (D). A dioptre is a measure of a person’s ability to see; a negative dioptre indicates difficulty seeing in the distance.
Atropine sulfate FGK contains the active substance atropine sulfate and was to be available as eye drops. Atropine sulfate is authorised in several countries of the European Union for slowing the progression of myopia in children and the treatment of other eye conditions, and for dilating the pupil before an eye examination.
Myopia is usually caused by the eyeball becoming longer. The active substance in Atropine sulfate FGK, atropine sulfate, binds to receptors (targets) in the eye called muscarinic receptors, blocking their activity. The exact way in which Atropine sulfate FGK works is not fully understood, but by blocking these receptors, it is thought to stimulate changes to the shape of the eye, which in turn prevent further elongation of the eyeball and therefore slow the progression of the myopia.
The company presented data from three main studies. The first study involved 576 children aged 3 to 17 years who had myopia of -0.50 to -6.00 D. For the first 3 years of the study, children were given either atropine sulfate at a concentration of 0.01% or 0.02%, or placebo eye drops (a dummy treatment). The main measure of effectiveness was the proportion of patients’ eyes whose myopia had worsened by less than 0.5 D after 3 years of treatment with either atropine sulfate 0.02% or placebo.
The second main study involved 250 children aged 6 to 16 years who had myopia of at least -1.00 D. Children were treated with atropine sulfate 0.01% or placebo for 2 years. The third main study involved 187 children aged 5 to 12 years who had myopia ranging from -1.00 to -6.00 D. Children were either treated with atropine sulfate 0.01% or with placebo for 2 years. In both studies, the main measure of effectiveness was the change in myopia after 2 years of treatment.
In May 2025, the Agency was concerned that the three main studies submitted by the company failed to show effectiveness of Atropine sulfate FGK for the treatment of myopia in children. In the first main study, there was no statistically significant difference between Atropine sulfate 0.02% and placebo in terms of the proportion of children whose myopia progressed by less than 0.50 D after 3 years of treatment. This means that the small difference observed may be due to chance. Results from the first main study suggested that Atropine sulfate FGK 0.01% may be more effective than placebo. However, the European Medicines Agency considered that, since the study failed to show effectiveness of the 0.02% concentration, it was unclear why the lower 0.01% concentration would be shown effective. Additionally, the second and third main studies failed to show effectiveness of the 0.01% concentration.
These concerns did not change after re-examination of the data provided and following the advice from a panel of experts. The Agency therefore maintained its opinion that the effectiveness of Atropine sulfate FGK had not been sufficiently demonstrated and recommended refusing marketing authorisation.
The company informed the Agency that there was no ongoing clinical trial with Atropine sulfate FGK at the time of publication.
Product details
- Name of medicine
- Atropine sulfate FGK
- Active substance
- atropine sulfate
- International non-proprietary name (INN) or common name
- atropine
- Therapeutic area (MeSH)
- Myopia
- Anatomical therapeutic chemical (ATC) code
- S01X
- EMA product number
- EMEA/H/C/006385
- Marketing authorisation applicant
- FGK Representative Service GmbH
- Opinion adopted
- 18/09/2025
- Opinion status
- Negative
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