Triesence (triamcinolone acetonide injectable suspension 40 mg/mL) was originally developed and manufactured by Alcon, receiving US Food and Drug Administration (FDA) approval in 2007 to treat ocular inflammatory conditions unresponsive to topical corticosteroids, as well as for visualization during vitrectomy. When Novartis acquired Alcon in 2010, it took over manufacturing and marketing of Triesence. However, beginning around 2019, supply chain problems disrupted production. Triesence was on the FDA Drug Shortage List for 5 years and was unavailable in the United States for more than 2 years.

In January 2023, Harrow acquired the US commercial rights to Triesence from Novartis and began working to rebuild the entire supply chain and manufacturing process. In October 2024, Harrow successfully relaunched the product, restoring access to this medication for retina surgeons. In our conversation, which has been edited for length and clarity, Amir H. Shojaei, PharmD, PhD, Harrow’s chief scientific officer, discusses the opportunities and challenges of reviving Triesence.

Retinal Physician: What impact did the unavailability of Triesence have on ophthalmologists? How is Harrow addressing those challenges?

Amir Shojaei: When Triesence first went on shortage and then became unavailable, it had a clear impact. Younger surgeons, especially those in training, didn’t have access to it at all. Experienced surgeons had to look for alternatives, which often meant using compounded products or off-label options—neither of which were ideal solutions.

When Harrow acquired the product, our goal was twofold. First, we had to bring Triesence up to current Good Manufacturing Practice standards and reintroduce it to the market. Second, we needed to make sure the ophthalmic community knew the product was available again. That includes clear communication, education, and support around reimbursement, which is critical to enabling its use in clinical practice.

Our approach is focused on ensuring a reliable long-term supply, maintaining high manufacturing standards, and supporting accessibility through appropriate reimbursement. Together, those steps are helping to restore Triesence’s role in ophthalmic care.

RP: What were the main challenges in reestablishing commercial-scale manufacturing for Triesence?

Amir Shojaei: Because of the lapse in production, a lot of work had to be done. When you transfer an NDA and try to restart production, [FDA] regulators expect you to meet current standards. FDA standards have been raised since 2007, and to relaunch Triesence we had to meet substantially higher burdens regarding testing and production than they did 20 years ago.

It’s a bit like discovering a hidden treasure—you need to polish and restore it before it’s ready to be put on display. To recreate the manufacturing process, we had to track down retired experts and learn why certain methods were originally used. Solving the underlying issues required some creative problem-solving. After that, we had to bring everything up to modern standards.

RP: What changes, if any, were made to the formulation or production process during the redevelopment of Triesence?

Amir Shojaei: The formulation and composition haven’t changed at all. It’s exactly the same product. But because sterility standards, testing protocols, and other requirements have evolved, we had to adapt to meet those new expectations.

The key component of Triesence is its unique formulation. It is a suspension with a defined particle size range, which is a feature that makes it effective. Achieving those characteristics requires highly precise testing and accurate reproduction of those tests. As a result, we had to re-engineer certain aspects of the process. Although the formulation itself remained unchanged, we updated the analytical testing methods and incorporated technology that wasn’t available in 2007 but is available today.

RP: How did you ensure the new manufacturing process met FDA standards?

Amir Shojaei: To bring Triesence back, we had to manufacture 3 consecutive commercial-scale batches under the FDA’s current standards and testing criteria (Figure 1). These process performance qualification (PPQ) batches had to pass a comprehensive series of tests. Once they did, we received the green light that the product was ready for market distribution. That served as our road map.

In terms of analytical work, we implemented a broader set of tests for particle size and conducted extensive analysis on the drug substance to ensure supply chain integrity—from raw materials to the active ingredient. We also evaluated all other manufacturing components to confirm they were properly tested and compliant. All this testing was applied to the PPQ batches. Once everything passed, we reached the point where the product could be introduced to the market. That’s exactly what Harrow did—we announced in October of last year that Triesence was back on track and ready for reintroduction.

RP: What steps is Harrow taking to ensure a reliable long-term supply of Triesence, and avoid future shortages?

Amir Shojaei: We’ve already secured a 5-year strategic supply agreement with our primary manufacturer. This agreement ensures continued production of Triesence well into the future. Although the term is 5 years, it’s a renewable agreement, and we fully expect it to be extended beyond that.

Harrow is a relatively young company, but everyone on our team shares a deep commitment to supply chain integrity. For every product, including Triesence, we build in redundancy at every stage. That means identifying and securing alternate suppliers for each component of the manufacturing process. If a product requires 10 raw materials, we don’t rely on just 1 source for each—we establish backup suppliers for all of them.

This approach isn’t unique to Triesence; it’s part of our broader strategy across the portfolio. But with Triesence, we prioritized this work due to the previous market absence. We reassessed every part of the supply chain. That includes the active pharmaceutical ingredient (API), which is often the most critical component. We’ve lined up redundant suppliers for the API, as well as for other key raw materials. Combined with our long-term manufacturing agreement, this puts us in a very strong position. We believe we’ve created a secure supply chain to ensure the reliable availability of Triesence.

RP: How is Harrow educating newer surgeons about Triesence?

Amir Shojaei: We regularly host speaker programs where experienced users of Triesence share how, when, and why they use the product. This gives newer or less familiar surgeons an opportunity to learn from those with hands-on experience.

In addition to speaker programs, our medical affairs team plays a key role. Our medical science liaisons engage directly with physicians to provide medically relevant information. These are not sales conversations—they’re focused on scientific discussion and education. Through both peer-to-peer engagement and medical outreach, we’re working to reintroduce Triesence and support its appropriate use in clinical practice.

RP: Are there plans to expand Triesence’s indications or develop alternative delivery methods?

Amir Shojaei: Yes, we’re actively exploring different approaches to deliver Triesence. Although the formulation would remain the same, we’re considering a “Triesence 2.0” concept—a new version with an alternative delivery method. This would provide surgeons with more options and extend the brand’s relevance and utility.

We’re also looking into expanding the approved indications. Ophthalmology, and particularly retina, is a tightly connected community. The more we engage with surgeons, the more we learn about other potential uses for Triesence. So, we’re taking a dual approach: expanding indications and innovating on delivery.

One thing we do at Harrow is listen closely to physicians. When surgeons propose clinical studies, we often support them—either by providing the product at no cost or sponsoring the study outright. These investigator-initiated studies can give us early signals about potential new indications. If those signals are strong, they may lead to larger, controlled studies required for regulatory approval.

RP: How are retina specialists responding to the return of Triesence? 

Amir Shojaei: Some surgeons are thrilled that the product is back. Others, who adapted to its absence, have been slower to readopt it into their practice. The decision by the Centers for Medicare and Medicaid Services (CMS) to provide a J-code (J3300) for Triesence has made a big difference. When surgeons don’t have to worry about out-of-pocket costs or budget constraints, they’re more likely to choose the product that offers the best clinical utility. And in that regard, Triesence stands out—it remains the only preservative-free corticosteroid approved for intraocular use and for visualization during surgery. So we’re seeing a second wave of interest. Even surgeons who had moved on are now taking a fresh look at the product. Overall, the feedback has been overwhelmingly positive.

RP: Is there anything else about Triesence or Harrow’s strategy that you’d like to highlight?

Amir Shojaei: I want to emphasize that the relaunch of Triesence reflects Harrow’s long-term commitment to the ophthalmology community. We’re not here to dabble—we’re here to stay. Harrow offers more than 16 branded, FDA-approved ophthalmic products, spanning both the front and back of the eye. That level of investment is rare, and it shows how deeply we’re committed to this space. Our goal is to grow further and go deeper—not just with Triesence, but across the ophthalmic landscape. This relaunch is part of a broader strategy to support physicians and patients for the long haul. RP