Ryjunea (atropine sulfate) / Sydnexis, Santen - LARVOL DELTA

Topical atropine for myopia prevention : Current study situation (PubMed, Ophthalmologie) - "Topical atropine is effective and well tolerated. Unresolved questions regarding dosing in non-Asian populations, treatment duration and long-term effects on complications should be addressed by further studies."

Journal • Review • Ophthalmology • Pediatrics

The FDA is convening an advisory meeting to review and discuss Sydnexis, Inc’s SYD-101, an investigational formulation of low-dose atropine intended for the treatment of pediatric progressive myopia (PPM). (Eyes On Eyecare) - "SYD-101 has the potential to become the first and only pharmaceutical treatment approved for progressive myopia in patients aged 3 to 14...The eye drop’s clinical performance in the phase 3 Study of Atropine for the Reduction of Myopia Progression (STAR) study (NCT03918915) was reported pre-NDA and post-NDA submission."

FDA filing • Ophthalmology

Cost-Effectiveness Analysis of Low-Dose Atropine Eye Drops (0.01%) for the Treatment of Myopia in Children: A United Kingdom Perspective. (PubMed, Pharmacoeconomics) - "Adding SYD-101 (0.01%) to SoC can be considered a cost-effective option for treating pediatric myopia in the United Kingdom over a lifetime horizon. These results support the integration of SYD-101 (0.01%) into routine clinical practice to enhance long-term visual outcomes and lower healthcare expenses."

HEOR • Journal • Ophthalmology • Pediatrics

Workforce challenges to implementation of myopia management in Europe: an electronic/telephone expert survey. (PubMed, Front Ophthalmol (Lausanne)) - "The European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency recently approved the first commercial preparation of low-concentration atropine, Ryjunea, for use in children aged 3 years and older to slow the progression of myopia...Policies and implementation pathways for myopia management in children are required to ensure equitable access. European guidelines for training in myopia management and national pathways and standards of care should be developed and endorsed by professional organisations to enable children and young people at risk of myopia progression to access appropriate interventions in a timely and economical fashion."

Journal • Ophthalmology • Pediatrics

Treatment Response to A Novel Low-Dose Atropine Formulation (SYD-101) in Children with Fast-Progressing Myopia: A Subgroup Analysis from the STAR Study (ARVO 2026) - "Younger children and those with milder myopia showed the strongest response to 0.01%, while children with higher baseline myopia demonstrated greater benefit from 0.03%. These findings suggest that treatment is most effective when initiated early, before myopia advances."

Clinical • Ophthalmology

STAAR: The Safety and Efficacy of SYD-101 in Children With Myopia (clinicaltrials.gov) - P3 | N=852 | Completed | Sponsor: Sydnexis, Inc. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

Sydnexis Receives Complete Response Letter from FDA for SYD-101 to Slow Pediatric Myopia Progression (Businesswire) - "Sydnexis’ NDA for SYD-101 was supported by the results of the Phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial....The FDA acknowledged in the complete response letter (CRL) that this primary endpoint was met but stated its view that the data do not support the effectiveness of low-dose atropine in children with myopia. No deficiencies were noted related to safety or product quality."

CRL • Ophthalmology

Sydnexis Announces European Commission Approval of SYD-101, the First and Only Pharmaceutical Treatment for Slowing the Progression of Pediatric Myopia (Businesswire) - "Sydnexis, Inc...announced that the European Commission (EC) has granted marketing authorization for SYD-101, the company’s proprietary low-dose atropine formulation, for slowing the progression of pediatric myopia. As the first and only approved pharmaceutical treatment option to treat myopia progression in EU countries, this approval marks a significant advancement in pediatric eye care. The approval is backed by data from the STAR study, Sydnexis’ pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities in children 3 to 14 years old at treatment initiation."

EMA approval • Ophthalmology

STAAR: The Safety and Efficacy of SYD-101 in Children With Myopia (clinicaltrials.gov) - P3 | N=852 | Active, not recruiting | Sponsor: Sydnexis, Inc. | Trial primary completion date: May 2025 ➔ May 2024

Trial primary completion date • Ophthalmology

The natural history of myopia progression in a large diverse pediatric population (ARVO 2025) - "Methods This analysis is from the vehicle-control group of a multicenter, randomized, double-masked clinical study (SYD-101-001; the STAR study) in children aged 3-14 years with myopia of -0.50 to -6.00 diopters (D)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Ophthalmology

Methods and baseline of a large, multicenter, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study) (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P3 data • Ophthalmology

Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of Pediatric Myopia (Businesswire) - "Sydnexis, Inc....today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, for slowing the progression of pediatric myopia....The CHMP positive opinion was primarily supported by data from the STAR study..."

CHMP • Ophthalmology

Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia (Businesswire) - "Sydnexis...today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States....The NDA application is based on three-year primary and secondary endpoints from the STAR Study, Sydnexis’ pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities."

FDA filing • PDUFA • Ophthalmology

STAAR: The Safety and Efficacy of SYD-101 in Children With Myopia (clinicaltrials.gov) - P3 | N=852 | Active, not recruiting | Sponsor: Sydnexis, Inc. | Trial primary completion date: Jun 2024 ➔ May 2025

Trial primary completion date • Ophthalmology

STAAR: The Safety and Efficacy of SYD-101 in Children With Myopia (clinicaltrials.gov) - P3 | N=852 | Active, not recruiting | Sponsor: Sydnexis, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date • Ophthalmology