Introduction to Triesence
Triesence, a preservative-free synthetic corticosteroid, has been a crucial medication in ophthalmology for visualization during vitrectomy and the treatment of ocular inflammatory conditions unresponsive to topical corticosteroids. After a prolonged period of shortage, Harrow Inc. has announced significant updates on the relaunch of Triesence.
Historical Context and Shortage
Triesence has been on the FDA Drug Shortage List for over five years, with all inventories depleted in the U.S. market for more than two years. This shortage forced ophthalmologists and retina specialists to rely on less ideal, off-label solutions, such as modifying preserved Kenalog-40, which posed potential risks to patients[1][4][5].
Relaunch Update
Harrow has made substantial progress in relaunching Triesence. The company has successfully manufactured the first of three commercial-scale process performance qualification (PPQ) batches of Triesence. The second and third PPQ batches are scheduled, and if these meet specifications, the new production process will be deemed complete, allowing Harrow to relaunch Triesence in 2024[1][4].
Manufacturing and Quality Assurance
The manufacturing process for Triesence involves complex steps, including analytical testing. Teams from South America, Europe, and the United States have collaborated to reinvent this process, ensuring the drug meets the required standards. This global effort underscores the commitment to delivering a high-quality product[1][4].
Market Analysis
Unmet Need in Ophthalmology
The relaunch of Triesence addresses a critical unmet need in ophthalmology. The drug's unique formulation, which is preservative-free, makes it superior to alternatives like Kenalog. Despite its higher price point of $944 per vial, justified by increased regulatory and manufacturing costs, Triesence offers safer and more effective treatment options for eye care professionals[2].
Market Potential
Harrow aims to produce over 500,000 units of Triesence annually, targeting a significant market growth. The initial inventory of 39,000 units is expected to be pre-ordered by strategic accounts, indicating strong demand. This positions Harrow for substantial market expansion in the ophthalmology sector[2].
Clinical Trials and Regulatory Compliance
While specific clinical trials data for the relaunch of Triesence is not detailed, the drug's FDA approval and the rigorous PPQ process ensure it meets stringent regulatory standards. The successful completion of PPQ batches is a critical step in ensuring the drug's safety and efficacy, aligning with broader trends in clinical trials where regulatory compliance is paramount[1][4].
Impact on Patient Care
The relaunch of Triesence brings much-needed relief for both eye care professionals and their patients. During the shortage, many were forced to use less ideal solutions, which posed potential risks. With Triesence back in the market, ophthalmologists can now provide safer, more effective treatments, improving surgical outcomes and patient care[5].
Pre-Commercialization Activities
Harrow’s commercial leadership is initiating pre-commercialization activities, including discussions with strategic accounts to pre-order the expected initial inventory of Triesence. Ophthalmologists and surgery centers interested in securing a quantity allocation can complete a form on Harrow’s website for an immediate supply review[1][4].
Billing and Ordering
Triesence is billed as a single-use vial of 40 milligrams or 40 units based on the HCPCS descriptor (J3300 Injection, triamcinolone acetonide, preservative-free, 1 mg). This clarity in billing and ordering processes will help streamline the distribution and use of the drug[5].
Market Projections
The relaunch of Triesence is expected to have a positive impact on Harrow’s market position and financial performance. Given the high demand and the drug’s unique benefits, Harrow is poised for significant market growth. The company’s ability to maintain a consistent and reliable supply will be crucial in sustaining this growth[2].
Conclusion
The relaunch of Triesence marks a significant milestone in addressing the unmet needs in ophthalmology. With its preservative-free formulation and FDA approval, Triesence offers safer and more effective treatment options. Harrow’s commitment to quality and regulatory compliance ensures that the drug will meet the high standards expected by healthcare professionals and patients.
Key Takeaways
- Relaunch Update: Harrow has completed the first of three PPQ batches for Triesence, with the second and third batches scheduled.
- Market Need: Triesence addresses a critical unmet need in ophthalmology, offering a safer alternative to preserved corticosteroids.
- Market Potential: Harrow aims to produce over 500,000 units annually, targeting significant market growth.
- Clinical Impact: The relaunch improves surgical outcomes and patient care by providing a safer and more effective treatment option.
- Pre-Commercialization: Harrow is engaging in pre-commercialization activities, including pre-orders from strategic accounts.
- Billing and Ordering: Clear billing and ordering processes are in place to facilitate the distribution of Triesence.
FAQs
Q: What is Triesence used for?
Triesence is used for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.
Q: Why was Triesence on the FDA Drug Shortage List?
Triesence was on the FDA Drug Shortage List for over five years due to manufacturing and supply chain issues, leading to a complete depletion of inventories in the U.S. market.
Q: What makes Triesence superior to other corticosteroids?
Triesence is preservative-free, making it a safer and more effective option compared to alternatives like Kenalog.
Q: How much does Triesence cost?
Triesence costs $944 per vial, a price justified by increased regulatory and manufacturing costs.
Q: What are the next steps in the relaunch of Triesence?
The next steps include the completion of the second and third PPQ batches. If these meet specifications, Harrow will relaunch Triesence in 2024.
Sources
- Eyewire News: Harrow Provides Triesence Relaunch Update.
- Seeking Alpha: Harrow - The Triesence Relaunch.
- Fortune Business Insights: Clinical Trials Market Size, Share, Industry Trends, Growth, 2032.
- Retinal Physician: Harrow Provides Triesence Relaunch Update.
- Harrow Investors: Harrow Relaunches TRIESENCE.
