Intravitreal FA Insert Effectively Controls Uveitis Recurrences

Quan Dong Nguyen, MD, MSc, Byers Eye Institute, Stanford University School of Medicine

Quan Dong Nguyen, MD, MSc

Use of a 0.18 mg fluocinolone acetonide intravitreal insert (FAi) effectively lowered the rate of uveitis recurrences and cumulative total recurrent episodes compared with a sham for patients with chronic non-infectious posterior uveitis (NIPU), according to phase 3 findings presented at the 2018 ARVO annual meeting.

In the double-masked study, the 1-year recurrence rate was just 37.9% in the FAi arm compared with 97.6% in the sham group (P <.001). More than 1 recurrence was experienced by 18.4% of those in the FAi group and for 67% in the sham group. One patients in the FAi arm had 5 or more recurrences compared with 16.7% in the sham group.

“Cumulative damage often results from recurrent episodes of diseases in eyes with uveitis, which can lead to severe loss of vision,” lead investigator Quan Dong Nguyen, MD, MSc, Byers Eye Institute, Stanford University School of Medicine, told MD Magazine.

“Treatment with an intravitreal injection, performed in an office setting, of sustained-release fluocinolone implant can lead to significant decrease in the rate of recurrences of inflammation over 1 year as well as the overall total number of recurrent episodes,” he said. “Such outcomes will be of benefits in preserving vision for the patients.”

The phase 3 study randomized 129 patients with NIPU to receive FAi (n = 87) or sham (n = 42). All patients had a greater than 1 year history of recurrent NIPU and had experienced 2 separate recurrences that required 3 or more months of systemic therapies to resolve or the use of 2 or more steroid injections.

For the enrolled participants, the mean duration of disease was 7.8 years (±6.7) in the FAi group and 5.6 years (±6.8) in the sham arm. Systemic therapy was received for prior uveitic recurrences for approximately half of patients in each arm. Baseline intraocular pressure (IOP) was 13.9 (±3.1) mmHg in the FAi group and 13.6 (±3.1) mmHg in the sham arm.

In patients with cataracts in phakic eyes, which were present in approximately a quarter of patients at baseline, extraction was possible for 33.3% of patients in the FAi arm compared with just 4.8% in the sham group.

There was a 1.3 (±3.6) mmHg mean change in IOP from baseline in patients treated with FAi compared with a 0.2 (±4.2) mmHg change in the sham arm. The mean IOP at 12 months was 15.2 (±4.3) mmHg in the FAi group and 13.8 (±3.5) mmHg in the sham arm. The IOP changed by ≥12 mmHg for 18.4% of patients in the FAi group and for 9.5% in the sham arm.

Despite more patients experiencing an increase in IOP in the FAi arm, the utilization of IOP-lowering medication and surgeries was similar between the groups. IOP medications were prescribed to 26.4% and 26.2% and surgery was required for 3.4% and 4.8% of patients in the FAi and sham arms, respectively.

The 0.19 mg FAi treatment, which is also known as Yutiq, was also explored in another phase 3 study for patients with NIPU. In this trial, 36.6% of patients treated with FAi had a recurrence at 12 months compared with 71.2% of patients in the sham group (P <.001).

In this trial, IOP increased by 2.0 mmHg in the FAi group compared with no increase in the sham arm; however, the need for IOP-lowering medication was the same between the arms at approximately 50%. Of those with phakic eyes at baseline, 18% had cataract surgery in the FAi group compared with 8.6% in the sham arm.

EyePoint Pharmaceuticals, the company marketing Yutiq, submitted a new drug application containing data from the 2 phase 3 studies to the FDA, which was accepted in March 2018. Under the Prescription Drug User Fee Act (PDUFA), the agency will decide on the application by November 5, 2018.

Another 0.19 mg FAi using the same technology, known as Iluvien, is approved for patients with diabetic macular edema (DME) who have been treated with corticosteroids without significant increase in IOP. The treatment, which is licensed to Alimera Sciences by EyePoint, is currently being considered for regulatory approval for NIPU in Europe.

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