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No systemic complications observed with intravitreal sirolimus for noninfectious uveitis
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DENVER — Intravitreal sirolimus does not seem to have any systemic adverse events in the treatment of noninfectious uveitis, according to a presentation here.
In a poster presented at the Association for Research in Vision and Ophthalmology annual meeting, Daniel Rosberger, MD, and colleagues observed the whole-blood pharmacokinetics of intravitreal sirolimus in 14 patients who took part in the double-masked phase of the SAKURA Study 1.
“The Study 1 results showed fairly unequivocally that sirolimus is a very good monotherapy for noninfectious uveitis, obviating the need in most patients for systemic immunology,” Rosberger told Ocular Surgery News.
In the 6-month study, three patients received intravitreal sirolimus injections of 44 µg, six received injections of 440 µg, and five received injections of 880 µg at months 0, 2 and 4.
After the first injection, sirolimus in the blood increased, reaching a Cmax of 0.337 ng/mL, 1.97 ng/mL and 3.06 ng/mL, at a mean Tmax of 0.69, 1.3 and 4.2 days, for those injected with 44 µg, 440 µg and 880 µg, respectively. By day 30, sirolimus concentrations declined toward the limit of quantitation level, the study said.
The mean AUC0-60d was 1.5 ngday/mL, 15 ngday/mL and 30.5 ngday/mL, respectively.
The same pattern occurred after month 2 and month 4 injections, with no change in mean Cmax and AUC0-60d between the first and third injections.
“It shows that in addition to being effective in the eye and safe in the eye as we measured the adverse events, it also doesn’t cause any systemic complications, which was the third part of making [intravitreal sirolimus] a potentially very useful treatment modality for uveitis and, in this study, the noninfectious uveitis,” Rosberger said. - by Kristie L. Kahl
Disclosure: Rosberger reports no relevant financial disclosures.