This article was originally published in a sponsored newsletter.
At the most recent Clinical Trials at the Summit meeting, I had the honor of presenting first-time clinical trial results on the 36-month data from the CALM Registry. This study assessed outcomes following treatment of chronic non-infectious uveitis affecting the posterior segment with the 0.18 mg fluocinolone acetonide intravitreal implant (IVT FAi/FAi; Yutiq, Alimera). This real-world data was collected from patients at participating US sites who were at least 18 years old and treated with the 0.18 mg FAi.
Safety data, including uveitis recurrence, optical coherence tomography (OCT), visual acuity, vitreous haze, intraocular pressure (IOP) measurements, adverse events, cataract extractions, and IOP-lowering surgeries, were collected at each follow-up visit. The study examined 267 eyes of 200 patients (63% female; 89% pseudophakic). The majority (69%) were white. Eighty-five percent of patients were diagnosed with posterior or panuveitis, most of which were idiopathic cases, and the most commonly known diagnosis was sarcoidosis.
I will outline the results below:
Recurrence of Uveitis and New Implants
In the 12 months before FAi, 84% of eyes had at least 1 recurrence of uveitis; but 36 months after implantation, 16.5% of eyes had at least 1 recurrence of uveitis. During the study, 4.5% of eyes received more than 1 FAi: 3.7% received 2 implants and 0.8% received 3.
Central Subfield Thickness (CST)
Reduction in CST was maintained post-FAi: The proportion of eyes with CST of at least 300 µm decreased from 56% at baseline to 40% at 36 months.
Visual Acuity
Throughout the 36 months of the trial, the proportion of eyes with visual acuity of 20/40 or better was stable post-FAi, and 19% of patients had an increase of at least 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters vs baseline.
IOP
IOP remained stable throughout the study: 17% of patients had IOPs greater than 10 mmHg more than baseline and 5.6% had IOPs more than 30 at any given point. The overall rate of IOP-lowering incisional surgery was 4.5%, which was categorized into tube surgeries (3%) and trabeculectomies 1.1%. The rate of selective laser trabeculoplasty was 1.1% as was the rate of micro-invasive glaucoma surgery (MIGS).
The 0.18 mg IVT FAi provided long-term improvements in inflammatory flares with no new safety signals in the treatment of chronic non-infectious uveitis affecting the posterior segment. Three years after implantation, the FAi not only showed long-term control of the disease with a substantial reduction in the rate of uveitis flares vs pre-FAi, but also demonstrated improved OCT findings and stable vision. The evidence from this real-world registry builds on controlled clinical studies and hopefully will provide physicians with another option to treat this disease.
