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Fluocinolone Intravitreal Implants Appear Effective for Uveitis: Presented at AAO

By Deanna M Green, PhD

ANAHEIM, CA -- November 20, 2003 -- Fluocinolone acetonide intravitreal implants reduce the rate of recurrence and the need for adjunctive therapy in patients with posterior uveitis, while improving visual acuity, according to findings presented here November 16^th at the 2003 American Academy of Ophthalmology Annual Meeting.

Significant increases in intraocular pressure (IOP) and cataract incidence, however, are also observed, said Glenn J. Jaffe, MD, Duke University Eye Center, Durham, North Carolina. Dr. Jaffe and the Fluocinolone Acetonide Implant Uveitis Study Group evaluated the safety and efficacy of a sustained-release fluocinolone acetonide intravitreal implant in patients with posterior uveitis.

Conventional treatments for uveitis include topical, systemic, and injectable immunosuppressives and corticosteroids. One major disadvantage of these treatments is that patients often require frequent administration over a long period of time.

Fluocinolone acetonide is an insoluble, synthetic corticosteroid that can be implanted into the sclera of the affected eye. An important advantage of this treatment is its controlled release of drug over a long period of time.

The multicentre study included 278 patients (mean age 43.5) with symptoms of recurrent non-infectious uveitis lasting over 1 year. Patients were randomised to receive either a 0.5 mg or 2.0 mg implant. The implant was designed to release 0.5 mcg/day - 2 mcg/day of the drug over a 3-year period. Efficacy and safety were assessed after 34 weeks of treatment in comparison to the non-implanted fellow eye.

Recurrence of symptoms was reported in only 2.9% of eyes receiving the fluocinolone implant. This was a significantly lower incidence than that reported in the non-implanted eye (43.7%, P < .001).

Visual acuity also improved significantly in implanted eyes. These patients showed an average 1-line improvement, from 20/68 at baseline to 20/58 at 34 weeks. Moreover, 26% of patients showed a 3-line or greater improvement in visual acuity. No significant improvement was seen in the non-implanted fellow eye.

While 59% of patients required systemic therapy before implantation, only 13% required such therapy at 34 weeks (P < .001). Similar reductions were seen for periocular steroid injection and topical corticosteroid use.

A significant increase in IOP was observed in eyes that were implanted with fluocinolone, from 14.6 at baseline to 19.1 at 34 weeks. Notably, the need for cataract extraction was also higher in the implanted eye, 13.5 versus 1.5% in the control eye. The severe complication rate was about 12%.

Dr. Jaffe concluded that "significant improvements in recurrence rates, use of adjunctive therapy, and visual acuity were observed following implantation as compared to the fellow eye." He also noted that "the expected adverse events, including increases in IOP and cataract incidence, were managed by conventional means."

"These patients will be followed for an additional 2.5 years," Dr. Jaffe added.


[Study Title: Fluocinolone acetonide intravitreal implant in patients with uveitis affecting the posterior segment of the eye. Abstract PA005]

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