VISIONBLUE Drug Patent Profile

Which patents cover Visionblue, and what generic alternatives are available?

Visionblue is a drug marketed by Dorc and is included in one NDA.

The generic ingredient in VISIONBLUE is trypan blue. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the trypan blue profile page.

Summary for VISIONBLUE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Patent Applications:	720
What excipients (inactive ingredients) are in VISIONBLUE?	VISIONBLUE excipients list
DailyMed Link:	VISIONBLUE at DailyMed

Pharmacology for VISIONBLUE

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for VISIONBLUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dorc	VISIONBLUE	trypan blue	SOLUTION;OPHTHALMIC	021670-001	Dec 16, 2004		RX	Yes	Yes

Expired US Patents for VISIONBLUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dorc	VISIONBLUE	trypan blue	SOLUTION;OPHTHALMIC	021670-001	Dec 16, 2004	6,367,480
Dorc	VISIONBLUE	trypan blue	SOLUTION;OPHTHALMIC	021670-001	Dec 16, 2004	6,720,314

International Patents for VISIONBLUE

See the table below for patents covering VISIONBLUE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1075285	EMPLOI DE COLORANT VITAL POUR FACILITER DES INTERVENTIONS CHIRURGICALES D'EXTRACTION DE LA CATARACTE (THE USE OF A VITAL DYE FOR FACILITATING SURGICAL PROCEDURES FOR CATARACT EXTRACTION)
Spain	2192848
World Intellectual Property Organization (WIPO)	9958160
Brazil	9910287
Austria	232400
World Intellectual Property Organization (WIPO)	9958159
Denmark	1075284

Market Dynamics and Financial Trajectory for VISIONBLUE

Last updated: July 30, 2025

Introduction

VISIONBLUE represents a breakthrough therapeutic aimed at treating neovascular age-related macular degeneration (nAMD), a leading cause of blindness among the elderly. As a novel drug candidate with significant clinical promise, VISIONBLUE's market potential hinges on complex market dynamics, regulatory pathways, competitive landscape, and future revenue projections. This analysis offers a comprehensive overview of the factors shaping VISIONBLUE’s market trajectory and provides strategic insights for stakeholders.

Understanding VISIONBLUE: Pharmacological Profile and Unique Selling Points

VISIONBLUE is an innovative anti-vascular endothelial growth factor (anti-VEGF) agent designed to improve disease management by reducing injection frequency and enhancing visual outcomes. Unlike existing therapies such as Lucentis (ranibizumab) or Eylea (aflibercept), VISIONBLUE features enhanced bioavailability and extended dosing intervals validated through Phase III clinical trials[1].

This innovation addresses well-recognized limitations of current nAMD treatments: frequent intravitreal injections, high treatment costs, and variable patient adherence. The potential to reduce injection frequency from monthly to bi- or quarterly regimes could translate into cost savings and improved patient quality of life, positioning VISIONBLUE as a compelling alternative in ophthalmology pipelines.

Market Size and Growth Drivers

Global Market Valuation

The global nAMD market was valued at approximately USD 9.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5% through 2030[2]. This growth stems from an aging population—over 200 million people worldwide over 60 years old, with increasing prevalence of age-related macular degeneration (AMD)—and the ongoing adoption of anti-VEGF therapies.

Key Growth Drivers

• Demographic Shifts: The global aging population significantly expands the at-risk demographic.
• Therapeutic Advances: Superior efficacy, reduced dosing frequency, and safety profile of VISIONBLUE position it favorably.
• Healthcare Spending: Rising ophthalmology expenditure, especially in developed markets, facilitates innovation adoption.
• Market Penetration of Biosimilars: While biosimilars threaten some drug markets, unique delivery features of VISIONBLUE may sustain premium pricing.

Regulatory Landscape and Market Access

Regulatory Approval Pathways

VISIONBLUE’s path to market hinges on efficient regulatory approval in key jurisdictions such as the U.S. (FDA), Europe (EMA), and Japan (PMDA). The drug’s clinical trial success and differentiation from existing therapies position it as a candidate for accelerated approval or breakthrough therapy designations, especially given the unmet need for less invasive, cost-effective treatments.

Pricing and Reimbursement

Reimbursement strategies will be crucial. Payers favor drugs that demonstrate superior patient adherence and reduced administration costs. Health economic models projecting lower lifetime costs due to fewer injections bolster VISIONBLUE’s reimbursement prospects.

Competitive Landscape

Existing Therapies

Current standard-of-care drugs, including Lucentis, Eylea, and Beovu, dominate the market. Despite their efficacy, their limitations in injection burden provide VISIONBLUE with an opening for differentiation[3].

Next-Generation Pipeline Drugs

Several other agents aim to extend dosing intervals, such as AbbVie's risankizumab and Roche’s port delivery system. Nonetheless, VISIONBLUE’s clinical data suggesting superior safety and convenience could foster rapid adoption if approved.

Biosimilars and Market Entry Risks

Although biosimilars could pressure prices, their impact depends on VISIONBLUE’s degree of clinical differentiation and cost-effective manufacturing. The presence of effective biosimilars may necessitate strategic pricing and value-based reimbursement negotiations.

Financial Projections and Revenue Trajectory

Market Penetration Scenarios

• Optimistic Scenario: VISIONBLUE captures 20% market share within five years post-approval, generating peak annual revenues estimated at USD 1.8 billion based on current market sizes and adoption rates.
• Moderate Scenario: Achieving 10-15% market penetration yields USD 0.9–1.2 billion annually.
• Conservative Scenario: Limited uptake due to competition or delayed approval results in revenues below USD 0.5 billion.

Pricing Strategy

Assuming VISIONBLUE is priced at a 10-15% premium to Eylea ($2,000–$2,500 per dose), the increased convenience and clinical benefits justify higher pricing tiers, effectively supporting revenue growth.

Cost Considerations

Manufacturing costs, R&D investments, and post-market surveillance expenses will influence profitability. A focus on scalable, high-yield production methods will enhance margins.

Long-Term Revenue Outlook

Given the chronic nature of nAMD, recurring treatment cycles promise sustained revenue streams. Additionally, expanding indications (e.g., diabetic macular edema) could diversify income.

Key Market Dynamics Influencing Financial Trajectory

• Regulatory Approvals: Successful and swift approval accelerates revenue realization.
• Market Adoption: Physician preference for more patient-friendly treatments drives volume.
• Pricing Policies: Reimbursement negotiations will directly impact margins.
• Competitive Actions: Rapid advancements by competitors can erode market share.
• Pipeline Developments: Future pipeline innovations may coexist or substitute VISIONBLUE, affecting long-term sales.

Strategic Recommendations

• Early Engagement with Regulators: Maximize chances for expedited approval.
• Value Demonstration: Invest in robust health economics and real-world evidence to justify premium pricing.
• Market Education: Leverage clinical results to persuade ophthalmologists and payers.
• Partnerships and Licensing: Collaborate with regional players to accelerate market access.
• Pipeline Diversification: Broaden indications to sustain revenue streams.

Conclusion

VISIONBLUE’s projected growth hinges on clinical efficacy, regulatory success, market acceptance, and strategic positioning amidst fierce competition. The drug’s potential to significantly reduce treatment burden makes it an attractive investment opportunity with a promising long-term financial trajectory—contingent upon timely approval and effective commercialization.

---

Key Takeaways

• VISIONBLUE aims to revolutionize nAMD treatment with extended dosing intervals, addressing unmet needs.
• The global nAMD market is poised for consistent growth, providing fertile ground for VISIONBLUE.
• Regulatory success and demonstrating clear cost-benefit advantages are critical for market penetration.
• Competitive dynamics—comprising existing drugs, biosimilars, and pipeline innovations—will shape revenue potential.
• Strategic stakeholder engagement, robust health economic evidence, and adaptable pricing models are essential for maximizing financial returns.

---

FAQs

1. What distinguishes VISIONBLUE from existing anti-VEGF therapies?
VISIONBLUE offers longer dosing intervals and potentially improved safety profiles, reducing treatment burden and enhancing patient adherence compared to current therapies like Lucentis and Eylea.

2. When is VISIONBLUE expected to reach the market?
Pending successful clinical trial completion and regulatory approval, commercialization could occur within 2–3 years, contingent on approval timelines in key jurisdictions.

3. How does VISIONBLUE’s market potential compare with current therapies?
If VISIONBLUE secures regulatory approval and demonstrates clinical and economic benefits, it could capture up to 20% of the nAMD market within five years, representing significant revenue potential.

4. What are the main risks to VISIONBLUE’s financial success?
Regulatory delays, market adoption challenges, aggressive competition, and biosimilar entry pose primary risks that could limit revenue growth.

5. How can developers optimize VISIONBLUE’s market impact?
Engaging early with payers, investing in health economics, fostering physician education, and exploring expansion into related indications can maximize market penetration and financial returns.