On November 30, 2007, the FDA approved triamcinolone acetonide injectable suspension (Triesence; Alcon), a preservative-free, synthetic steroid for visualization during vitrectomy and treatment of uveitis and other ocular inflammatory conditions. Triamcinolone had been used for years off label to treat retinal vascular diseases, in particular diabetic macular edema, with excellent success. With the approval of Triesence, the off-label use of triamcinolone acetonide injection (Kenalog-40) stopped. Moreover, the manufacturer of Keanlog-40 added additional wording to the label including a notation that the drug was for intramuscular or intra-articular use only, not for intraocular use, because adequate studies to demonstrate the safety of Kenalog injection use by subconjunctival, sub-Tenon, retrobulbar, and intraocular (intravitreal) injections have not been performed. They added that intraocular injection of corticosteroid formulations containing benzyl alcohol, such as Kenalog injection, is not recommended because of potential toxicity from the benzyl alcohol.

Recently, Novartis, the manufacturer of Triesence, announced that the drug will be backordered for almost 6 months with no alternative manufacturer available. The American Society of Retina Specialists (ASRS) is aware of the shortage and is closely monitoring the shortages. It is unclear what is causing the shortage, but supply chain issues have been blamed. Triesence is not the only retinal product in short supply. Fluorescein sodium (Akorn) is also backordered, and this has forced retinal surgeons to ration fluorescein angiography. Verteporfin (Visudyne; Bausch Health) is also in short supply due to a manufacturing problem at the Alcami Carolinas Corporation, the only factory able to make the drug.

For Triesence, we thankfully have alternatives. One could also use a dexamethasone implant (Ozurdex; Allergan/Abbvie), which is FDA approved for similar indications, or even off-label Kenalog. An opinion by the Ophthalmic Mutual Insurance Company (OMIC) in 2020 stated that off-label use of either Kenalog or compounded, preservative-free form from a 503A compounding pharmacy with a patient-specific prescription could be used if the FDA has noted a drug shortage. Since the FDA has placed Triesence on the FDA drug shortage list, the opinion covers off-label use. The OMIC opinion specifically notes that informed consent should include the usual risk/benefit discussion, with the addition of informing the patient that Kenalog is not approved for intravitreal injection and the manufacturer has recommended against ophthalmic use, but given the drug shortage, this is the only source of the drug.

Like everything disrupted by the pandemic, the global supply chain issues have affected retina surgeons. Hopefully, our world will return to normal soon. RP