Systemic therapy of corticosteroids and immunosuppressants better preserved vision in patients with uveitis compared to Bausch & Lomb‘s long-lasting corticosteroid intraocular implant in a clinical trial supported by the National Eye Institute, a branch of the National Institutes of Health.
In 7 years, visual acuity remained stable in patients receiving systemic therapy and declined by an average of 1 line on an eye chart among patients with the implant, according to the study.
“This trial provides good evidence that for the average patient with uveitis, systemic therapy would be the 1st choice of treatment,” chair of the report’s writing committee Dr. John Kempen said in prepared remarks. “The visual outcome over the long run was better, on average, there were fewer adverse outcomes, and the cost is less.”
The team’s findings were published in the Journal of the American Medical Association.
Bausch & Lomb’s fluocinolone intraocular implant won FDA approval in 2005 and early data showed that the implant was effective at controlling inflammation, but also had local ocular side effects. The Multicenter Uveitis Steroid Treatment Trial (MUST) assessed whether the long-lasting implant was improvement over systemic therapy for patients with uveitis.
The study enrolled 255 uveitis patients and randomized them to either receive the fluocinolone implant or systemic treatment with corticosteroids and immunosuppressants.
For the 1st 2 years, visual acuity stayed the same between the 2 groups. After 7 years, the difference in visual acuity emerged. The team reported that patients treated with an implant experienced reactivations of uveitis after 5 years, which coincided with a decline in visual acuity.
“These results emphasize the importance of longer follow-up for studies of treatments for chronic diseases that are likely to require years of treatment,” the manuscript’s lead statistician, Elizabeth Sugar, said.
Patients in the implant group were more likely to develop cataracts, intraocular pressure elevation and other ocular side effects, according to the study. Patients who were treated with systemic therapy had increased risk of needing antibiotics.
“We were able to avoid most of the systemic adverse outcomes that people worry about with systemic corticosteroid and immunosuppressive therapy by following expert panel guidelines. The result is meaningful not just in ophthalmology but in other disease areas, because many different fields use this strategy to treat the inflammatory diseases of many different organs,” Kempen said.
“The results of this trial suggest that oral corticosteroids and immunosuppression may be a preferable initial choice for therapy of more severe uveitis,” chair of the Must research group, Dr. Douglas Jabs said. “However, the implant may have a role in treating patients where systemic therapy fails to control inflammation or patients cannot tolerate the oral medications.”
“Must results provide guidance to clinicians and their patients in making informed decisions about uveitis treatment,” NEI program director Sangeeta Bhargava added.
