Therapies such as RYZUMVI (Phentolamine Ophthalmic Solution 0.75%), MYDCOMBI, OMIDRIA, and others are expected to drive growth in the mydriasis market over the coming years.
DelveInsight has released a comprehensive report titled “Mydriasis – Market Insights, Epidemiology, and Market Forecast-2034”, providing detailed analysis of historical and projected epidemiology as well as market trends for mydriasis across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
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Some of the key facts of the Mydriasis Market Report:
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The mydriasis market is projected to experience consistent growth, with a robust compound annual growth rate (CAGR) anticipated between 2024 and 2034. This upward trend is largely attributed to the increasing incidence of age-related eye conditions—such as cataracts, glaucoma, and macular degeneration—which are leading to a rise in eye exams and surgical procedures requiring pupil dilation.
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Leading companies like Omeros Corporation, Ocuphire Pharma, and others are actively developing treatments aimed at expanding therapeutic options in the mydriasis space.
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In the U.S., the growing prevalence of chronic health conditions such as diabetes and hypertension is also contributing to increased demand for routine eye examinations, many of which involve pharmacologic dilation to detect potential complications.
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Despite the growing need, the mydriasis treatment market continues to face several significant challenges. These include a limited number of safe and effective therapies, especially for long-term use, a lack of treatments targeting the root causes, and insufficient research and development of innovative drugs. There is also a clear need for better diagnostic tools to accurately assess the type and severity of mydriasis in patients.
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Currently, RYZUMVI is the only approved medication specifically designed to rapidly reverse pharmacologically induced mydriasis, underscoring the lack of available treatments for individuals seeking quick recovery of normal vision after dilation. Moreover, there are no emerging drugs in the pipeline targeting this specific condition, highlighting a notable treatment gap in the market.
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In 2023, across the 7 major markets (7MM), eye examinations and routine check-ups made up around 338 million of the total ophthalmic cases. That year also saw approximately 8.6 million cataract surgeries, 538,000 glaucoma procedures, 1.6 million refractive surgeries, 505,000 vitreoretinal surgeries, and 2.9 million surgeries falling under other categories.
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Geographically, the United States accounted for the largest share, contributing 53% of the total eye exams and surgeries. The EU4 and the UK made up 32%, while Japan represented the remaining 15%.
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Approved in September 2023, RYZUMVI is the first FDA-approved eye drop designed to reverse pharmacologically induced mydriasis (pupil dilation) caused by agents like phenylephrine or tropicamide
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Key Mydriasis companies such as Théa Laboratories, Omeros Corporation, Ocuphire Pharma, and others are evaluating new drugs for Mydriasis to improve the treatment landscape.
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Promising Mydriasis therapies include RYZUMVI (Phentolamine Ophthalmic Solution 0.75%), MYDCOMBI, OMIDRIA, and others.
Mydriasis Overview
Mydriasis refers to the abnormal enlargement of the pupils, typically due to non-physiological factors. Under normal conditions, pupils dilate in dim lighting to improve vision and constrict in bright light to protect the retina. However, in mydriasis, the pupils remain dilated even in bright environments, suggesting an underlying problem.
This condition results from an imbalance between the sympathetic and parasympathetic nervous systems. While the sympathetic system promotes dilation, the parasympathetic system—primarily via the oculomotor nerve (cranial nerve III)—regulates constriction. Damage to the oculomotor nerve or the iris sphincter can impair this balance, leading to persistent dilation. Mydriasis is commonly associated with traumatic brain injuries, elevated intracranial pressure, or certain neurological conditions. It may also be triggered by medications such as anticholinergics or by recreational substances like cocaine and ecstasy.
Common symptoms include sensitivity to light (photophobia), blurred vision, and discomfort in brightly lit settings. In some cases, patients may also experience headaches or eye pain, particularly when the dilation stems from trauma or neurological causes. A fixed, dilated pupil on one side can be a warning sign of increased intracranial pressure and may require urgent medical intervention.
Mydriasis Market Outlook
Mydriasis, or abnormal pupil dilation, can result from a variety of causes, including medications, neurological disorders, or physical trauma. The main objective of treatment is to normalize pupil size, ease symptoms like photophobia and blurred vision, and manage the root cause of the condition.
Treatment strategies depend on the specific underlying cause. The first step in managing mydriasis is accurate diagnosis to determine its origin.
Treatment practices differ between countries, with certain mydriatic agents being preferred depending on regional protocols. Commonly used agents include tropicamide, phenylephrine, and MYDRIASERT. In the United States, phenylephrine (1.0%) is often favored for its rapid onset and short duration, particularly in surgical contexts. Similarly, tropicamide and phenylephrine are frequently used in the UK and Germany to induce pupil dilation for diagnostic and therapeutic procedures.
These drugs function by targeting receptors in the iris: tropicamide works by blocking muscarinic receptors, thereby relaxing the iris sphincter muscle, while phenylephrine activates alpha-adrenergic receptors to stimulate the iris dilator muscle—both resulting in pharmacologically induced pupil dilation.
Mydriasis can also occur due to certain drugs, such as anticholinergics (e.g., atropine, scopolamine) and stimulants (e.g., cocaine, amphetamines). If the condition is medication-induced, stopping the drug often allows symptoms to resolve naturally within a few hours or days. In cases where quicker recovery is needed, reversal eye drops can help return the pupil to normal size, restore vision clarity, and reduce light sensitivity, minimizing daily disruptions.
In more severe scenarios—such as third nerve palsy or elevated intracranial pressure—mydriasis may signal a medical emergency, requiring immediate evaluation and possibly surgical treatment. In certain instances, medications like pilocarpine or alpha-blockers like dapiprazole (commonly used for glaucoma) may be prescribed to promote pupil constriction.
Overall, mydriasis management is a comprehensive process aimed at addressing both the cause and the symptoms to enhance patient well-being and visual comfort.
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Mydriasis Marketed Drugs
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RYZUMVI (Phentolamine Ophthalmic Solution 0.75%): Viatris/Ocuphire Pharma
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MYDCOMBI: Eyenovia
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OMIDRIA: Rayner Surgical/Omeros
Scope of the Mydriasis Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Mydriasis Companies: Théa Laboratories, Omeros Corporation, Ocuphire Pharma, and others
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Mydriasis Therapies: RYZUMVI (Phentolamine Ophthalmic Solution 0.75%), MYDCOMBI, OMIDRIA, and others.
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Mydriasis Therapeutic Assessment: Mydriasis current marketed and Mydriasis emerging therapies
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Mydriasis Market Dynamics: Mydriasis market drivers and Mydriasis market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
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Mydriasis Unmet Needs, KOL’s views, Analyst’s views, Mydriasis Market Access and Reimbursement
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Key benefits of the Mydriasis Market Report:
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The Mydriasis market report covers a descriptive overview and comprehensive insight of the Mydriasis Epidemiology and Mydriasis market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Mydriasis market report provides insights into the current and emerging therapies.
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The Mydriasis market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Mydriasis market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Mydriasis market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Mydriasis Patient Share (%) Overview at a Glance
5. Mydriasis Market Overview at a Glance
6. Mydriasis Disease Background and Overview
7. Mydriasis Epidemiology and Patient Population
8. Country-Specific Patient Population of Mydriasis
9. Mydriasis Current Treatment and Medical Practices
10. Unmet Needs
11. Mydriasis Emerging Therapies
12. Mydriasis Market Outlook
13. Country-Wise Mydriasis Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Mydriasis Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Mydriasis Pipeline Insights, DelveInsight
“Mydriasis Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Mydriasis market. A detailed picture of the Mydriasis pipeline landscape is provided, which includes the disease overview and Mydriasis treatment guidelines.
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.
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