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

STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03. (PubMed, Ophthalmol Ther) - P3 | "Atropine sulfate 0.01% and 0.03% effectively slowed myopia progression in children, with greatest efficacy in Fast Progressors Subgroup 1. Both concentrations were well tolerated with manageable side effects, supporting atropine sulfate as a treatment option for pediatric myopia."

Journal • Ophthalmology • Pediatrics

Economic evaluation, resource utilisation, and associated economic burden of myopia management: a systematic literature review. (PubMed, J Glob Health) - "Among the paediatric population, the most cost-effective interventions included digital strategies for early prevention and screening, low-dose atropine (0.05%) with an incremental cost-effectiveness ratio of 234 USD/Spherical Equivalent Refraction reduction, and non-pharmacological defocus incorporated multiple segment lenses (7074 USD/quality-adjusted life year (QALY) gained). In adults, ranibizumab was cost-effective (35 288 USD/QALY gained) for pathologic myopia, while small incision lenticule extraction surgery yielded long-term savings (15 USD/QALY gained)...s Myopia presents a substantial economic burden, highlighting the need for optimising cost-effective interventions to reduce severity, prevent long-term vision loss, and lessen the financial burden. However, limited data, geographical bias, methodological inconsistencies, and heterogeneity in outcomes emphasise the need for more standardised, comprehensive evaluations to ensure broader applicability."

HEOR • Journal • Review • Ophthalmology • Pediatrics

Efficacy and Safety of Low-Concentration Atropine in Slowing Myopia Progression in Children in Japan: The Randomized, Double-Blind Phase II/III ORANGE Study. (PubMed, Ophthalmol Sci) - "Both concentrations were well tolerated. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Clinical • Journal • P2/3 data • Ophthalmology

Awareness of Myopia Associated Complications and Perspectives on Myopia Management Among Parents of Children with Myopia in France and the UK. (PubMed, Patient Relat Outcome Meas) - "UK parents reported higher adoption rates of myopia control methods, including orthokeratology (47% France, 68% UK), atropine (46% France, 63% UK), and red-light therapy (44% France, 67% UK)...UK parents adopted control methods more frequently than French parents. Financial burden remains a significant concern, emphasizing the need for enhanced parental education and affordable access to myopia control."

Journal • Cataract • Glaucoma • Ophthalmology

A Balancing Act: Low-Dose Atropine Significantly Slows Pediatric Myopia Progression Without a Clinically Meaningful Risk of Rebound (Accelerated Myopia Progression Following Treatment Cessation) (ISPOR-EU 2025) - "LDA significantly slows progression of paediatric myopia versus control over two years of treatment without a clinically meaningful rebound effect or safety concerns associated with MDA or HDA. These findings may inform guidelines and decision making to expand access to effective myopia control options."

Clinical • Ophthalmology • Pediatrics

After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Atropine sulfate FGK. (European Medicines Agency)

European regulatory • Ophthalmology

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