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

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