Local steroids are often a first-line treatment for uveitic conditions, offering intraocular inflammation control without systemic immunosuppression. In recent years, changes in FDA approvals, supply chains, and corporate ownership have affected the availability and use of several of these agents. This article reviews recent developments in the US market for locally delivered steroid therapies—including product discontinuations, relaunches, and label expansions—and considers their clinical implications for uveitis management.
Retisert
Bausch + Lomb introduced the 0.59 mg fluocinolone acetonide intravitreal implant Retisert in April 2005, after it received US Food and Drug Administration (FDA) approval as a treatment for chronic noninfectious posterior uveitis. The implant delivers fluocinolone acetonide at approximately 0.6 µg/day initially, tapering to 0.3–0.4 µg/day, with sustained release over approximately 30 months. Retisert was evaluated in the Multicenter Uveitis Steroid Treatment (MUST) Trial, which found cataract formation in nearly all phakic eyes by 3 years, IOP-lowering medications needed in about 77%, and glaucoma surgery required in 37%. Despite these risks, Retisert significantly reduced uveitis recurrences and decreased reliance on systemic immunosuppression compared to systemic therapy. The surgical implant is especially valuable in cases of uveitis that do not respond to systemic immunosuppression, in uveitic conditions contained only to the eye where immunosuppression could not be approved, or in patients who are intolerant to systemic immunosuppression.
Earlier this year, Bausch + Lomb sent a letter to customers announcing that Retisert will be discontinued in April 2026, citing difficulties in securing manufacturing components. Patients currently benefiting from this implant will need to consider alternative treatments—such as the injectable 0.18 mg fluocinolone acetonide intravitreal implant Yutiq (ANI Pharmaceuticals) or the 0.7 mg dexamethasone intravitreal implant Ozurdex (AbbVie), or alterations in systemic immunosuppression. However, no approved implant currently matches Retisert’s 0.59 mg dose and duration of effect.
Triesence
Alcon received FDA approval for Triesence (triamcinolone acetonide injectable suspension, 40 mg/mL) in November 2007 for use in sympathetic ophthalmia, temporal arteritis, noninfectious uveitis, other ocular inflammatory conditions unresponsive to topical steroids, and as an aid to visualization during vitrectomy. Unlike Kenalog-40 (Bristol Myers Squibb), Triesence is preservative-free, eliminating benzyl alcohol to reduce risks of intraocular toxicity.
Triesence was manufactured and distributed by Novartis following that company’s acquisition of Alcon in 2011. During and after the COVID-19 pandemic in 2020, Triesence faced a prolonged drug shortage due to manufacturing disruptions. During a 2-year period when Triesence was unavailable in the United States, some physicians turned to off-label Kenalog-40, despite its preservative content. In 2023, Harrow acquired exclusive US rights to Triesence, relaunching the product in late 2024 after stabilizing its supply chain
and obtaining FDA pass-through reimbursement.
The reintroduced Triesence included a 486% price increase, from approximately $161 to $944 per dose. Despite this, no other FDA-approved intravitreal steroid matches Triesence’s combination of preservative-free formulation and intraoperative applications.
Yutiq / Iluvien
In October 2018, the FDA approved Yutiq for chronic noninfectious uveitis affecting the posterior segment. The injectable intravitreal insert releases steroid over up to 36 months and is indicated specifically for intraocular inflammation.
In 2023, EyePoint Pharmaceuticals licensed Yutiq’s US commercial rights to Alimera Sciences. The company already marketed its own 0.19 mg fluocinolone acetonide intravitreal implant, Iluvien, which had received FDA approval in 2014 for diabetic macular edema (DME). Iluvien is also approved in Europe and the Middle East for noninfectious posterior uveitis.
Last year, ANI Pharmaceuticals acquired Alimera Sciences, including both Yutiq and Iluvien; that deal closed in the fall of 2024. Following the acquisition, ANI expanded Iluvien’s US label to include chronic noninfectious posterior uveitis—bringing parity with its US indications and aligning it with its approved European use in uveitis. RP