Myopia Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Ziemer Group, NIDEK CO., LTD, 2EyesVision, Carl Zeiss AG, Alcon, CooperVision

March 26 09:54 2025
Myopia Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Ziemer Group, NIDEK CO., LTD, 2EyesVision, Carl Zeiss AG, Alcon, CooperVision
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Myopia pipeline constitutes 8+ key companies continuously working towards developing 10+ Myopia treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

Myopia Pipeline Insight, 2025 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Myopia Market.

 

The Myopia Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the Myopia Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Myopia treatment therapies with a considerable amount of success over the years.

  • Myopia companies working in the treatment market are Sydnexis, Inc., Laboratorios Sophia S.A de C.V., Vyluma, Inc., Hai Yen Eye Care, Qilu Pharmaceutical Co., Ltd., Eyenovia Inc., Santen Pharmaceutical, University of Waterloo, iVeena Delivery Systems, Ocumension (Hong Kong) Limited, Cloudbreak Therapeutics, LLC, Bayer, Novartis, Center For Excellence In Eye Care, LENZ Therapeutics, Inc, and others, are developing therapies for the Myopia treatment

  • Emerging Myopia therapies in the different phases of clinical trials are- SYD-101, Alleance®, NVK-002, BHVI1, QLM3004, Atropine 0.1%, DE-127, ClearCare, IVMED 85, OT-101 Ophthalmic Solution, CBT-009, VEGF Trap-Eye (BAY86-5321), Ranibizumab, ketorolac (Acular LS), Aceclidine + Brimonidine, and others are expected to have a significant impact on the Myopia market in the coming years.

  • In March 2025, Sydnexis, Inc., a pre-commercial biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101, setting a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would become the first and only pharmaceutical treatment available in the United States for slowing the progression of pediatric myopia.

  • In November 2024, Eyenovia’s stock price has dropped by over two-thirds following the failure of a Phase III study of its drug-device combination for myopia to meet its primary endpoint

  • In July 2024, CooperVision, a global leader in myopia management, successfully wrapped up its role as a Gold sponsor at the 5th World Congress of Paediatric Ophthalmology and Strabismus (WCPOS V). The event emphasized CooperVision’s commitment to advancing pediatric eye health in Asia and reinforced its position as a pioneer in myopia control. WCPOS V, organized by the World Society of Paediatric Ophthalmology and Strabismus, attracted more than 1,200 pediatric ophthalmologists, researchers, and industry leaders from around the world, demonstrating its significant impact and global reach.

  • In May 2024, Dopavision, an innovative company focused on revolutionizing pediatric eye care, has revealed topline results from its MyopiaX-1 proof-of-concept clinical trial (NCT04967287). The six-month results of this randomized, controlled trial show that MyopiaX is safe and well-tolerated. MyopiaX employs targeted photobiomodulation to the eye, aiming to control the progression of myopia in children.

 

Myopia Overview

Myopia, also known as nearsightedness, is a common vision condition where distant objects appear blurry while close objects can be seen clearly. This occurs when the eye is too long relative to the focusing power of the cornea and lens, causing light rays to focus at a point in front of the retina instead of directly on its surface. Myopia can be corrected with glasses, contact lenses, or refractive surgery.

 

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Emerging Myopia Drugs Under Different Phases of Clinical Development Include:

  • SYD-101: Sydnexis, Inc.

  • Alleance®: Laboratorios Sophia S.A de C.V.

  • NVK-002: Vyluma, Inc.

  • BHVI1: Hai Yen Eye Care

  • QLM3004: Qilu Pharmaceutical Co., Ltd.

  • Atropine 0.1%: Eyenovia Inc.

  • DE-127: Santen Pharmaceutical

  • ClearCare: University of Waterloo

  • IVMED 85: iVeena Delivery Systems

  • OT-101 Ophthalmic Solution: Ocumension (Hong Kong) Limited

  • CBT-009: Cloudbreak Therapeutics, LLC

  • VEGF Trap-Eye (BAY86-5321): Bayer

  • Ranibizumab: Novartis

  • ketorolac (Acular LS): Center For Excellence In Eye Care

  • Aceclidine + Brimonidine: LENZ Therapeutics, Inc

 

Myopia Route of Administration

Myopia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

  • Oral

  • Parenteral

  • Intravenous

  • Subcutaneous

  • Topical

 

Myopia Molecule Type

Myopia Products have been categorized under various Molecule types, such as

  • Monoclonal Antibody

  • Peptides

  • Polymer

  • Small molecule

  • Gene therapy

 

Myopia Pipeline Therapeutics Assessment

  • Myopia Assessment by Product Type

  • Myopia By Stage and Product Type

  • Myopia Assessment by Route of Administration

  • Myopia By Stage and Route of Administration

  • Myopia Assessment by Molecule Type

  • Myopia by Stage and Molecule Type

 

DelveInsight’s Myopia Report covers around 10+ products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Myopia product details are provided in the report. Download the Myopia pipeline report to learn more about the emerging Myopia therapies

 

Some of the key companies in the Myopia Therapeutics Market include:

Key companies developing therapies for Myopia are – Ziemer Group, NIDEK CO., LTD, 2EyesVision, Carl Zeiss AG, Alcon, Haag-Streit Holding (Metall Zug), CooperVision, Topcon Healthcare Inc., and others.

 

Myopia Pipeline Analysis:

The Myopia pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Myopia with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Myopia Treatment.

  • Myopia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Myopia Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Myopia market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Myopia drugs and therapies

 

Myopia Pipeline Market Drivers

  • Increasing Prevalence, Technological Advancements, Growing Awareness, Rising Screen Time, Supportive Government Initiatives, are some of the important factors that are fueling the Myopia Market.

 

Myopia Pipeline Market Barriers

  • However, High Treatment Costs, Limited Access in Rural Areas, Lack of Awareness, Side Effects and Complications, Regulatory Challenges , and other factors are creating obstacles in the Myopia Market growth.

 

Scope of Myopia Pipeline Drug Insight

  • Coverage: Global

  • Key Myopia Companies: Sydnexis, Inc., Laboratorios Sophia S.A de C.V., Vyluma, Inc., Hai Yen Eye Care, Qilu Pharmaceutical Co., Ltd., Eyenovia Inc., Santen Pharmaceutical, University of Waterloo, iVeena Delivery Systems, Ocumension (Hong Kong) Limited, Cloudbreak Therapeutics, LLC, Bayer, Novartis, Center For Excellence In Eye Care, LENZ Therapeutics, Inc, and others

  • Key Myopia Therapies: SYD-101, Alleance®, NVK-002, BHVI1, QLM3004, Atropine 0.1%, DE-127, ClearCare, IVMED 85, OT-101 Ophthalmic Solution, CBT-009, VEGF Trap-Eye (BAY86-5321), Ranibizumab, ketorolac (Acular LS), Aceclidine + Brimonidine, and others

  • Myopia Therapeutic Assessment: Myopia current marketed and Myopia emerging therapies

  • Myopia Market Dynamics: Myopia market drivers and Myopia market barriers

 

Request for Sample PDF Report for Myopia Pipeline Assessment and clinical trials

 

Table of Contents

1. Myopia Report Introduction

2. Myopia Executive Summary

3. Myopia Overview

4. Myopia- Analytical Perspective In-depth Commercial Assessment

5. Myopia Pipeline Therapeutics

6. Myopia Late Stage Products (Phase II/III)

7. Myopia Mid Stage Products (Phase II)

8. Myopia Early Stage Products (Phase I)

9. Myopia Preclinical Stage Products

10. Myopia Therapeutics Assessment

11. Myopia Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Myopia Key Companies

14. Myopia Key Products

15. Myopia Unmet Needs

16 . Myopia Market Drivers and Barriers

17. Myopia Future Perspectives and Conclusion

18. Myopia Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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