Presbyopia Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, NICE Approvals, Mechanism of Action, ROA, IND, NDA Approval and Companies by DelveInsight

Presbyopia Clinical Trials

(Albany, USA) DelveInsight’s, “Presbyopia Pipeline Insight” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Presbyopia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

The report provides a detailed description of the Presbyopia drugs, including the mechanism of action, type, stage, route of administration, molecule type, clinical studies, inactive pipeline products, and NDA approvals (if any). The report also covers commercial and clinical activities of the pipeline products from the pre-clinical developmental phase to the marketed stage. Additionally, it presents the ongoing developments in the therapeutics segment, including collaborations, licensing, mergers & acquisitions (M&A), funding, designations, and other product-related details.

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Key Takeaways from the Presbyopia Pipeline Report

• DelveInsight’s Presbyopia pipeline report depicts a robust space with 10+ active players working to develop 10+ pipeline therapies for Presbyopia treatment.
• In April 2025, Tenpoint Therapeutics, Ltd. (“Tenpoint”), a global, clinical-stage biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BRIMOCHOL™ PF for the treatment of presbyopia, an age-related near-vision loss condition impacting approximately two billion people globally and 128 million people in the United States.
• In November 2024:- Alcon Research- The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population. Participants will be expected to attend 5 office visits for an individual duration of participation of approximately 64 days.
• In October 2024, LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application.
• The leading Presbyopia Companies such as Glaukos Corporation, Orasis Pharmaceuticals, Novartis, Cellix Bio, Visus Therapeutics, AbbVie, Vyluma, Lenz Therapeutics, Ocuphire Pharma, JIXING Pharmaceuticals, Eyenovia, among others.
• Promising Presbyopia Therapies such as LX-OPH-162, Research programme, STN 1013600, GLK-302, Nyxol, VTI-001, LNZ100, MicroLine (Pilocarpine Ophthalmic), CSF-1 (PresbiDrops), Nyxol, VT-101 (Brimochol), AGN-241622, and others.

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Presbyopia Emerging Drugs Profile

• LNZ100: Lenz Therapeutics

LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine, a selective muscarinic receptor agonist. It works by constricting the pupil, creating a pinhole effect that improves near vision. Unlike other pupil-constricting agents, aceclidine has a unique mechanism of action that decouples the miotic effect from the stimulation of the ciliary muscle, reducing the risk of myopic shift and accompanying brow ache. This allows LNZ100 to provide a broad patient population with a long-lasting and efficient treatment for presbyopia, a condition characterized by the gradual hardening of the lens and decline in near vision with age. Currently, the drug is in Phase III stage of its clinical trial for the treatment of presbyopia.

• GLK-302: Glaukos Corporation

Glaukos Corporation is developing GLK-302, a sterile ophthalmic topical cream containing the active ingredient pilocarpine, for the treatment of presbyopia. GLK-302 is designed to be applied to the eyelid, allowing the pilocarpine to be delivered through the dermis to the eye. The mechanism of action involves pilocarpine, a muscarinic acetylcholine receptor agonist, which acts on the M3 and M1 receptors in the eye to cause pupillary constriction and increase the depth of focus, thereby improving near visual acuity in presbyopic patients without significantly deteriorating distance vision. Currently, the drug is in Phase II stage of its clinical trial for the treatment of presbyopia.

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Presbyopia Companies

Some of the leading companies working in the pipeline are Visus Therapeutics, Glaukos Corporation, Cellix Bio, Orasis Pharmaceuticals, Cellix Bio, and others.

Presbyopia Drugs ROA

Presbyopia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Presbyopia Drug Molecule Type

Presbyopia Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

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Presbyopia Treatment Outlook:

The Presbyopia treatment pipeline is gaining momentum due to several key drivers, including the rising global prevalence of age-related vision disorders, increasing awareness and diagnosis rates, and growing demand for non-invasive and convenient treatment options like eye drops and intraocular lenses. Technological advancements in ophthalmology and the emergence of novel pharmacological therapies are further accelerating pipeline activity. Moreover, favorable regulatory support and increased investments in R&D by pharmaceutical companies are fueling innovation in the presbyopia space.

However, barriers persist, such as the high cost of advanced treatments, limited long-term efficacy data for newer therapies, and challenges in patient compliance, especially for drop-based regimens. Additionally, intense competition among emerging therapies and a cautious adoption rate by clinicians may hinder rapid market penetration. Safety concerns and side effects associated with certain investigational drugs also pose significant hurdles in the clinical development process.

Scope of the Presbyopia Pipeline Report

• Coverage- Global
• Presbyopia Companies- Glaukos Corporation, Orasis Pharmaceuticals, Novartis, Cellix Bio, Visus Therapeutics, AbbVie, Vyluma, Lenz Therapeutics, Ocuphire Pharma, JIXING Pharmaceuticals, Eyenovia, among others.
• Presbyopia Therapies- LX-OPH-162, Research programme, STN 1013600, GLK-302, Nyxol, VTI-001, LNZ100, MicroLine (Pilocarpine Ophthalmic), CSF-1 (PresbiDrops), Nyxol, VT-101 (Brimochol), AGN-241622, and others.
• Presbyopia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Presbyopia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

1. Introduction

2. Executive Summary

3. Presbyopia: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. Presbyopia – DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III)

8. LNZ100: Lenz Therapeutics

9. Drug profiles in the detailed report…..

10. Mid Stage Products (Phase II)

11. GLK-302: Glaukos Corporation

12. Drug profiles in the detailed report…..

13. Early Stage Products (Phase I)

14. Drug Name: Company Name

15. Preclinical Stage Products

16. Drug Name: Company Name

17. Drug profiles in the detailed report…..

18. Inactive Products

19. Presbyopia – Collaborations Assessment- Licensing / Partnering / Funding

20. Presbyopia – Unmet Needs

21. Presbyopia – Market Drivers and Barriers

22. Appendix

About DelveInsight

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