Latest news with #SYD-101
Yahoo
5 days ago
- Business
- Yahoo
Sydnexis Announces European Commission Approval of SYD-101, the First and Only Pharmaceutical Treatment for Slowing the Progression of Pediatric Myopia
Exclusive-Licensing Partner Santen Will Commercialize SYD-101 Under the Brand Name Ryjunea® in the European Union DEL MAR, Calif., June 05, 2025--(BUSINESS WIRE)--Sydnexis, Inc., ( a pre-commercial stage biopharmaceutical company today 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. "This marks a significant milestone for Sydnexis and, most importantly, for pediatric patients with progressive myopia, their families, and physicians as the first and only approved pharmaceutical treatment option in Europe," said Perry Sternberg, Chief Executive Officer of Sydnexis. "This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention." The marketing approval from the EC follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Santen, a Japan-based company specialized in eye health, offering innovative products and services in over 60 countries worldwide, licensed the rights from Sydnexis to commercialize SYD-101 in the regions of Europe, Middle East, and Africa (EMEA) and will launch SYD-101 under the brand name Ryjunea. "The EU approval of SYD-101 is a recognition of the compelling safety and efficacy data generated from our landmark STAR study," said Patrick Johnson, Ph.D., President of Sydnexis. "This validates the potential benefit that SYD-101 can provide to pediatric myopes in Europe and we are excited about our continued interactions with the Food and Drug Administration (FDA) leading up to our October 23 PDUFA date." Myopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. By 2050, global prevalence is projected to increase and affect more than 740 million children and adolescents and 5 billion people in total. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening co-morbidities later in life. "As a Pediatric Ophthalmologist with a rapidly growing number of myopia patients around the world, the EU approval of SYD-101 is truly exciting and it provides an important new tool for physicians to combat this global epidemic," said Dr. Donny Suh, Gavin Herbert Eye Institute, University of California at Irvine. "The benefits of low-dose atropine have long been recognized in the eye care community, but we now finally have an approved and thoroughly vetted treatment option. This marks a new era in our ability to slow the progression of myopia and protect the vision of millions of children worldwide." About Sydnexis, Inc.: Founded in 2014, Sydnexis, Inc. ( is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital. View source version on Contacts For media inquiries, please contact: media@
Business Wire
5 days ago
- Business
- Business Wire
Sydnexis Announces European Commission Approval of SYD-101, the First and Only Pharmaceutical Treatment for Slowing the Progression of Pediatric Myopia
DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis, Inc., ( a pre-commercial stage biopharmaceutical company today 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. 'This marks a significant milestone for Sydnexis and, most importantly, for pediatric patients with progressive myopia, their families, and physicians as the first and only approved pharmaceutical treatment option in Europe,' said Perry Sternberg, Chief Executive Officer of Sydnexis. 'This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention.' The marketing approval from the EC follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Santen, a Japan-based company specialized in eye health, offering innovative products and services in over 60 countries worldwide, licensed the rights from Sydnexis to commercialize SYD-101 in the regions of Europe, Middle East, and Africa (EMEA) and will launch SYD-101 under the brand name Ryjunea. 'The EU approval of SYD-101 is a recognition of the compelling safety and efficacy data generated from our landmark STAR study,' said Patrick Johnson, Ph.D., President of Sydnexis. 'This validates the potential benefit that SYD-101 can provide to pediatric myopes in Europe and we are excited about our continued interactions with the Food and Drug Administration (FDA) leading up to our October 23 PDUFA date.' Myopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. By 2050, global prevalence is projected to increase and affect more than 740 million children and adolescents and 5 billion people in total. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening co-morbidities later in life. 'As a Pediatric Ophthalmologist with a rapidly growing number of myopia patients around the world, the EU approval of SYD-101 is truly exciting and it provides an important new tool for physicians to combat this global epidemic,' said Dr. Donny Suh, Gavin Herbert Eye Institute, University of California at Irvine. 'The benefits of low-dose atropine have long been recognized in the eye care community, but we now finally have an approved and thoroughly vetted treatment option. This marks a new era in our ability to slow the progression of myopia and protect the vision of millions of children worldwide.' About Sydnexis, Inc.: Founded in 2014, Sydnexis, Inc. ( is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital.
Yahoo
01-05-2025
- Business
- Yahoo
Sydnexis Announces Three Abstracts Accepted for Poster Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting
DEL MAR, Calif., May 01, 2025--(BUSINESS WIRE)--Sydnexis, Inc., ( a pre-commercial stage biopharmaceutical company, announces that three abstracts have been accepted for poster presentations at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting taking place from May 4 to 8 in Salt Lake City, UT. These posters present clinical data related to the STAR Study, Sydnexis' groundbreaking pivotal phase 3 clinical trial evaluating SYD-101, a novel and proprietary low-dose atropine formulation to slow the progression of pediatric myopia. Two of the posters feature baseline methodologies and a 36-month analysis of myopia progression in a globally diverse population of 282 patients. The third poster highlights the benefits of SYD-101. "We are pleased to share what makes SYD-101's proprietary formulation novel in our landmark STAR Study, which is the largest ever clinical trial completed for the treatment of slowing the progression of pediatric myopia," said Patrick Johnson, Ph.D., President at Sydnexis. "We look forward to this first of many opportunities to engage with the broader ophthalmology community about how the landmark study may impact future treatment paradigms for the growing pediatric myopia epidemic." Sydnexis recently announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SYD-101 and assigned a PDUFA target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option available in the United States for the treatment of the progression of pediatric myopia. Abstract and Poster Details Title: The natural history of myopia progression in a large diverse pediatric Author: Janet K. Cheetham, Pharm.D., Sydnexis Inc. et alDate: Tuesday, May 6, 2025Location: Calvin L. Rampton Salt Palace Convention Center Poster HallPoster: A0117 Title: Methods and baseline of a large, multi-center, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study).Lead Author: Patrick Johnson, Ph.D., Sydnexis Inc. et alDate: Tuesday, May 6, 2025Location: Calvin L. Rampton Salt Palace Convention Center Poster HallPoster: A0118 Title: Effect of pH and BAK in low-dose atropine on pupil dilation in dutch belted Author: Tim Murphy, M.S., Sydnexis Inc. et alDate: Tuesday, May 6, 2025Location: Calvin L. Rampton Salt Palace Convention Center Poster HallPoster: A0132 About Pediatric Myopia: Myopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. By 2050, global prevalence is projected to increase and affect more than 740 million children and adolescents and 5 billion people in total. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening comorbidities later in life. About Sydnexis, Inc.: Founded in 2014, Sydnexis, Inc. ( is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital. View source version on Contacts For media inquiries, please contact: media@
Business Wire
01-05-2025
- Business
- Business Wire
Sydnexis Announces Three Abstracts Accepted for Poster Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting
DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis, Inc., ( a pre-commercial stage biopharmaceutical company, announces that three abstracts have been accepted for poster presentations at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting taking place from May 4 to 8 in Salt Lake City, UT. These posters present clinical data related to the STAR Study, Sydnexis' groundbreaking pivotal phase 3 clinical trial evaluating SYD-101, a novel and proprietary low-dose atropine formulation to slow the progression of pediatric myopia. Two of the posters feature baseline methodologies and a 36-month analysis of myopia progression in a globally diverse population of 282 patients. The third poster highlights the benefits of SYD-101. 'We are pleased to share what makes SYD-101's proprietary formulation novel in our landmark STAR Study, which is the largest ever clinical trial completed for the treatment of slowing the progression of pediatric myopia,' said Patrick Johnson, Ph.D., President at Sydnexis. 'We look forward to this first of many opportunities to engage with the broader ophthalmology community about how the landmark study may impact future treatment paradigms for the growing pediatric myopia epidemic.' Sydnexis recently announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SYD-101 and assigned a PDUFA target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option available in the United States for the treatment of the progression of pediatric myopia. Abstract and Poster Details Title: The natural history of myopia progression in a large diverse pediatric population. Lead Author: Janet K. Cheetham, Pharm.D., Sydnexis Inc. et al Date: Tuesday, May 6, 2025 Location: Calvin L. Rampton Salt Palace Convention Center Poster Hall Poster: A0117 Title: Methods and baseline of a large, multi-center, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study). Lead Author: Patrick Johnson, Ph.D., Sydnexis Inc. et al Location: Calvin L. Rampton Salt Palace Convention Center Poster Hall Poster: A0118 Title: Effect of pH and BAK in low-dose atropine on pupil dilation in dutch belted rabbits. Lead Author: Tim Murphy, M.S., Sydnexis Inc. et al Date: Tuesday, May 6, 2025 Location: Calvin L. Rampton Salt Palace Convention Center Poster Hall Poster: A0132 About Pediatric Myopia: Myopia is the most common eye disease in children, impacting approximately one-third of children and adolescents worldwide. By 2050, global prevalence is projected to increase and affect more than 740 million children and adolescents and 5 billion people in total. Once considered a benign refractive condition, even at low levels, myopia is now associated with many serious irreversible sight-threatening comorbidities later in life. About Sydnexis, Inc.: Founded in 2014, Sydnexis, Inc. ( is a privately held, pre-commercial stage biopharmaceutical company based in San Diego, California. Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia and the risk of associated co-morbidities. The Phase 3 clinical trial is now completing the fourth-year randomized withdrawal for exploratory endpoints and third year results will be announced upon completion of the fourth year of the study. The company is venture-backed by four major investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital.
