Last updated: February 20, 2026
What is NDC 75907-0025?
NDC 75907-0025 describes Iluvien, a corticosteroid intravitreal implant developed by Alimera Sciences. It delivers fluocinolone acetonide for long-term management of diabetic macular edema (DME). Approved by the FDA in 2014, Iluvien's indications include diabetic macular edema in patients who have previously received corticosteroids.
Market Size and Dynamics
Key Therapeutic Area: Diabetic Macular Edema
- Prevalence: Approximately 7.7 million Americans have diabetic retinopathy, with DME affecting about 50% of these patients.[1]
- Market Potential: The global DME treatment market is projected to grow from $2.3 billion in 2022 to over $4 billion by 2028, with some sources citing a compound annual growth rate (CAGR) near 10%.[2]
- Current Standard of Care:
- Anti-VEGF agents (e.g., Lucentis, Eylea) have dominant share.
- Corticosteroids (triamcinolone, dexamethasone implants) serve as alternative, especially in cases resistant or contraindicated to anti-VEGF.
- Market Share of Iluvien:
- Estimated at less than 5% in the intravitreal implant segment; dominant players are dexamethasone (Ozurdex) and anti-VEGF agents.[3]
Competitive Environment
| Product |
Type |
Approval Year |
Market Penetration |
Market Share (Estimated) (2022) |
| Lucentis (Ranibizumab) |
Anti-VEGF |
2006 |
40-50% |
|
| Eylea (Aflibercept) |
Anti-VEGF |
2011 |
35-45% |
|
| Ozurdex (Dexamethasone) |
Corticosteroid implant |
2009 |
10-15% |
|
| Iluvien (Fluocinolone) |
Corticosteroid implant |
2014 |
<5% |
|
Pricing and Revenue Trends
- Iluvien (Per Dose): Average wholesale price (AWP) around $8,000–$9,000 per implant.[4]
- Annual Treatment Cost: Given the implant's longevity (up to 36 months), annualized costs approximate $3,000–$4,000.
- Revenue Growth:
- Limited market penetration constrains revenue. Estimated global sales of Iluvien in 2022 approximate $50–$75 million.
Price Projections
Short-term (Next 2 Years)
- Pricing Stability: No major inflation anticipated; pricing largely dictated by reimbursement patterns.
- Market Penetration: Slow growth due to competition from more established therapies and physicians' preference for anti-VEGF.
- Projected Revenue: Slight increase to $80–$100 million, driven by expanding indications and geographic markets, especially in Europe and Asia.
Long-term (Next 5 Years)
- Market Evolution Factors:
- Entry of biosimilars or generics could reduce price.
- New indications or combination therapies might reshape demand.
- Improved physician familiarity with Iluvien could lead to higher adoption in specific patient subgroups.
- Price Trends:
- Prices expected to remain stable or decline by 10–15%, aligning with typical drug market dynamics and biosimilar entries.
- Potential for volume-driven growth rather than price increase.
Price Comparison with Similar Products
| Product |
Dose Cost |
Duration |
Typical Annual Cost |
Market Share (Estimated) |
| Iluvien |
~$8,500 |
Up to 36 months |
~$3,000–$4,000 |
<5% |
| Ozurdex |
~$7,000 |
Up to 6 months |
~$14,000 (yearly) |
10–15% |
| Anti-VEGF (Eylea) |
~$2,000/month |
Monthly |
~$24,000/year |
40–50% |
Note: Cost figures are approximate averages based on wholesale and reimbursement data.
Regulatory and Reimbursement Landscape
- FDA Approval: Confirmed in 2014 for DME.
- Reimbursement:
- Medicare, Medicaid, and private insurers reimburse based on CPT codes for intravitreal injections.
- Reimbursement caps influence pricing strategies.[5]
- Off-label Use: Limited, especially outside approved indications.
Strategic Implications
- Market Share Expansion: Focus on multi-year durability and tailored patient selection.
- Pricing Strategy: Maintain competitive pricing relative to perceived value and reimbursement policies.
- Geographic Expansion: Emerging markets might present premium growth opportunities, despite pricing pressures.
Key Takeaways
- NDC 75907-0025 (Iluvien) operates in a competitive, slowly growing segment primarily dominated by anti-VEGF therapies.
- Price per implant remains stable, with minor declines expected in response to market dynamics and biosimilar pressures.
- Long-term revenue prospects hinge on increased adoption, geographic expansion, and potential new indications.
- Market share remains constrained but steady, with possible upside from tailored therapies for resistant cases.
FAQs
Q1: What factors influence the pricing of Iluvien?
Reimbursement policies, competition from other intravitreal implants, manufacturing costs, and negotiated discounts impact pricing strategies.
Q2: How does Iluvien compare cost-wise with alternatives?
It offers a longer-lasting implant but at higher per-dose prices compared to monthly anti-VEGF injections, which reduces treatment frequency.
Q3: What are the growth opportunities for Iluvien?
Expanding indications, increasing use in resistant DME cases, and geographic expansion into emerging markets.
Q4: Will biosimilars or generics affect Iluvien’s price?
Potentially, especially if patent challenges or biosimilar approvals occur, leading to price reductions.
Q5: What are the main barriers to increased market share?
Physician familiarity with existing therapies, safety concerns linked to corticosteroids (e.g., elevated intraocular pressure), and reimbursement hurdles.
Citations
- American Diabetes Association. (2022). Diabetic Retinopathy and Diabetic Macular Edema. Diabetes Care, 45(suppl 1), S105–S117.
- MarketsandMarkets. (2022). Diabetic Macular Edema Market.
- EvaluatePharma. (2022). Market share analysis of intravitreal therapies.
- IQVIA. (2022). Wholesale Price Data for Ophthalmic Implants.
- Centers for Medicare & Medicaid Services. (2021). Reimbursement policies for intravitreal injections.
[1] American Diabetes Association. (2022). Diabetes Care, 45(suppl 1), S105–S117.
[2] MarketsandMarkets. (2022). Diabetic Macular Edema Market.
[3] EvaluatePharma. (2022). Market share analysis.
[4] IQVIA. (2022). Wholesale Price Data.
[5] Centers for Medicare & Medicaid Services. (2021). Reimbursement policies.
