Last updated: March 27, 2026
What is NDC 00406-9062?
NDC 00406-9062 corresponds to Vyzulta (latanoprostene bunod) ophthalmic solution, indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It was approved by the FDA in December 2017.
Market Size and Demand Dynamics
Current Market Volume
The global glaucoma medication market was valued at approximately $3.7 billion in 2022. Projected CAGR is around 4.8% through 2027, reaching approximately $4.6 billion.
Market Share of Vyzulta
- As of 2023, Vyzulta captures an estimated 3-4% of the U.S. ophthalmic treatment market for glaucoma.
- Annual sales revenue approximates $70-100 million in the U.S.
- Growth driven by increasing diagnosis rates and expanding ophthalmology practices.
Competitive Landscape
- Main competitors include prostaglandin analogs (e.g., Latanoprost, Travoprost), beta-blockers, and other combination therapies.
- Vyzulta offers a dual mechanism—raising interest among prescribers.
Factors Influencing Demand
- Rising prevalence: Global glaucoma prevalence is projected to reach 111 million by 2040.
- Older populations: Aging demographics increase demand.
- Formulation advancements: Once-daily dosing supports adherence.
Pricing Overview
Current Price Points
- Average wholesale price (AWP) for Vyzulta in the U.S.: approximately $470-$500 per 2.5 mL bottle.
- Insurance reimbursement typically reduces net patient cost; co-pays range from $10-$50.
- Comparable prostaglandin analogs priced from $400-$550.
Market Penetration Factors
- Patent protection until at least 2030.
- Insurance coverage policies influence patient access.
- Physician familiarity and preference impact prescriptions.
Revenue Projections
| Year |
Estimated Market Share |
Sales Volume (Units) |
Revenue (USD millions) |
| 2023 |
3% |
200,000 |
70 |
| 2024 |
4.5% |
300,000 |
110 |
| 2025 |
6% |
400,000 |
150 |
| 2026 |
7.5% |
500,000 |
185 |
| 2027 |
9% |
600,000 |
200 |
Note: These projections assume steady adoption growth, with no significant new entrants or generic competition within forecasted periods.
Price Projections and Outlook
- Domestic prices are expected to stabilize around $470-$510 per bottle, adjusted for inflation and reimbursement dynamics.
- Competitive pricing pressures may emerge if generics or biosimilars enter the market post-patent expiry.
- International markets could see different pricing, especially in regions with lower healthcare spending.
Policy and Regulatory Considerations
- Patent exclusivity exists until at least 2030; further extensions are unlikely without new patents.
- Pricing regulations vary; potential drug price caps or negotiation mechanisms in healthcare systems could influence future prices.
- Ongoing real-world evidence collection could impact prescriber perception and reimbursement.
Key Takeaways
- Vyzulta remains a niche ophthalmic treatment with moderate market share.
- Market size is driven by glaucoma prevalence, rising older population, and formulary adoption.
- Prices hover around $470-$500 per bottle, with growth predicated on increased prescribing and payer acceptance.
- Revenue projections indicate slow, steady growth to approximately $200 million in the U.S. by 2027.
- Potential competition and regulatory changes could impact long-term pricing strategies.
FAQs
1. How does Vyzulta compare with other glaucoma treatments?
Vyzulta offers a dual mechanism of action, combining nitric oxide donation with prostaglandin analog effects. It may provide additional intraocular pressure reduction with once-daily dosing but faces competition from well-established prostaglandin analogs.
2. What factors could alter price projections?
Introduction of generics, changes in insurance reimbursement, patent challenges, or new clinical evidence influencing prescriber preference.
3. Is Vyzulta approved outside the U.S.?
As of 2023, Vyzulta has U.S. approval. Other markets are evaluating regulatory pathways; some countries may have approval processes pending.
4. What is the typical reimbursement landscape for Vyzulta?
Reimbursement is primarily through Medicare, commercial insurers, and Medicaid, with co-pays varying. Reimbursement rates influence patient out-of-pocket costs and prescribing habits.
5. Are there ongoing clinical trials affecting Vyzulta’s future?
Yes, ongoing studies assess efficacy, long-term safety, and comparative effectiveness. Positive results could boost market penetration and value.
Sources
- Grand View Research. (2023). Glaucoma Drugs Market Size, Share & Trends Analysis.
- FDA. (2017). FDA approves Vyzulta for glaucoma.
- IQVIA. (2023). United States Prescription Audit.
- EvaluatePharma. (2022). Ophthalmology market forecasts.
- Medicare Reimbursement Data. (2023).
[1] Grand View Research. (2023). Glaucoma Drugs Market Size, Share & Trends Analysis.
[2] FDA. (2017). FDA approves Vyzulta for glaucoma.
[3] IQVIA. (2023). United States Prescription Audit.
[4] EvaluatePharma. (2022). Ophthalmology market forecasts.
[5] Medicare Reimbursement Data. (2023).
