atropine sulfate (DE-127) / Santen - LARVOL DELTA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025 (European Medicines Agency) - "The European Medicines Agency has recommended the refusal of a paediatric use marketing authorisation (PUMA) for Atropine sulfate FGK, a medicine intended for the treatment of myopia (short-sightedness) in children aged 6 to 10 years. The Agency issued its opinion on 22 May 2025. The company that applied for authorisation, FGK Representative Service GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion." "

CHMP • Ophthalmology

Economic Modelling of Myopia Management: A Systematic Literature Review (ISPOR 2025) - "Key Cost Effectiveness Findings: Atropine formulations: 0.05% was the most cost-effective Atropine concentration for controlling myopia progression compared to 0.025% and 0.01% in children in Hong Kong...Anti-VEGF Treatments: Ranibizumab was more cost-effective than verteporfin photodynamic therapy (vPDT) for treating myopic choroidal neovascularisation (mCNV) in the UK and China. Conbercept was found to be slightly more cost-effective than ranibizumab in China... This SLR highlighted the diverse economic modelling approaches used to assess myopia management strategies, predominantly evaluated in Asian populations. With the increasing prevalence of myopia, its geographic spread and long-term clinical manifestations, there is a need for more comprehensive framework for economic evaluations in myopia."

Review • Ophthalmology

Systematic Literature Review on the Economic Burden of Myopia (ISPOR 2025) - "Australia: Lifetime CPP for traditional myopia management (TMM) was $7,437 and for spectacles was $7,280 China: Lifetime CPP for TMM was $8,006 and low-dose atropine treatment was $4,453... This SLR highlights the substantial financial impact of myopia and the urgent need for cost-effective management strategies. Despite high prevalence, there is scarcity of published economic studies in myopia and the findings have limited generalisability due to the predominance of studies in Asian populations."

HEOR • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Atropine Ophthalmic Solution to Reduce Myopia Progression in Pediatric Subjects: The Randomized, Double-Blind Multicenter Phase II APPLE Study. (PubMed, Asia Pac J Ophthalmol (Phila)) - "Atropine doses of 0.005% and 0.01% effectively reduced myopia progression in children but no effect was noted with 0.0025%. All doses of atropine were safe and well tolerated."

Clinical • Journal • P2 data • Dermatology • Ophthalmology • Pediatrics • Pruritus

Atropine Ophthalmic Solution to Reduce Myopia Progression in Pediatric Subjects: The Randomized, Double-Blind Multicenter Phase II APPLE Study. (PubMed, Asia Pac J Ophthalmol (Phila)) - "Atropine doses of 0.005% and 0.01% effectively reduced myopia progression in children but no effect was noted with 0.0025%. All doses of atropine were safe and well tolerated."

Clinical • Journal • P2 data • Dermatology • Ophthalmology • Pediatrics • Pruritus

Myopia imaging biomarkers to predict atropine response by optical coherence tomography and fundus photography (ARVO 2022) - "Therefore, the GCL+ thickness and Redness may be associated with atropine response, suggesting their potential use as biomarkers to predict drug response before treatment."

Biomarker • Diabetic Retinopathy • Ophthalmology • Retinal Disorders