PANTHER Study offers 1-year results for fluocinolone acetonide intravitreal implant

Examples of Improvement and Failure Following Treatment with Fluocinolone Intravitreal Implant on OCT (top row) and FA (bottom row) (Images courtesy of Sumit Sharma, MD)

The FDA-approved fluocinolone acetonide intravitreal implant, 0.18 mg (Yutiq; EyePoint Pharmaceuticals) is a low-dose steroid implant indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.¹ It is known to provide excellent control of retinal inflammation in noninfectious uveitis, and previous clinical data have demonstrated a favorable safety profile.²

To explore inflammation control in patients with ongoing, active noninfectious uveitis, we developed the PANTHER study (NCT04340505). PANTHER is an ongoing, prospective, investigator-initiated study analyzing the use of the fluocinolone acetonide implant in patients with active noninfectious uveitis (N = 31).

Fluorescein angiography (FA) and optical coherence tomography (OCT) are mainstays of monitoring noninfectious uveitis affecting the posterior segment. FA images can show leakage, whereas OCT does not show frank cystoid macular edema. By contrast, OCT can show significant cystoid macular edema, whereas FA images have minimal leakage. For these reasons, PANTHER focuses on both ultrawide-field FA and OCT images at baseline and following the fluocinolone acetonide implant.

The primary outcome measures in PANTHER are the incidences of inflammation control and recurrence following the fluocinolone acetonide implant. Imaging measures were assessed using semiautomated analysis, which allows us to quantify the amount of leakage seen on FA and changes in central subfield thickness via OCT. A key distinguishing factor of PANTHER is that all included patients had active uveitis at baseline. Of the 31 patients initially enrolled, 29 patients continued through the 1-year mark.

At 1 year, it was interesting to find that patients had a high chance of needing rescue therapy within the first 6 months (38% of patients), but after 6 months the need for rescue therapy decreased significantly (7% of patients).

Thirteen of 29 patients received rescue therapy in the first year. Of the 13, 6 received a repeat fluocinolone acetonide implant. Of those who were treated with a second implant, 3 improved, 1 had no response, and 2 are awaiting further follow-up. It was up to the investigating clinician to determine whether a patient needed rescue therapy, and criteria included worsening examination findings or worsening metrics on FA and OCT.

At 1 year, FA and OCT measures were worse on average in patients who needed rescue therapy compared with nonrescue patients. At baseline, patients who had more leakage on FA and edema on OCT were more likely to need rescue therapy. In addition, there was a larger difference in OCT measures between rescued and nonrescued patients compared with FA metrics.

Additionally, the safety data are reassuring. None of the patients needed incisional surgery, and no serious adverse events were reported. Looking at the 1-year data, we saw that there were no safety issues, including in patients who received a second implant.

Even though there was a high rescue rate after 1 year, the patients who did well did exceptionally well. Because a large portion of patients in the clinical trials for the fluocinolone acetonide implant had inactive noninfectious uveitis at baseline, it is to be expected that the rescue rate would be different in this study because all patients had active noninfectious uveitis.⁴ The fluocinolone acetonide implant is a low-dose steroid that does a great job in providing consistent basal inflammation control over 36 months, and we look forward to obtaining more long-term data in years 2 and 3.

Sumit Sharma, MD

P: 800-223-2273

Sharma practices at the Cole Eye Institute, Cleveland Clinic, in Cleveland, Ohio. He is a consultant/contractor with AbbVie, Alimera, Bausch & Lomb, EyePoint Pharmaceuticals, Regeneron, Genentech/Roche, Clearside Biomedical, and receives financial support from Gilead, Genentech/Roche, Santen, and IONIS.

References

1 Yutiq. Package insert. EyePoint Pharmaceuticals; 2022.

2 Jaffe GJ, Pavesio CE, Study Investigators. Effect of a fluocinolone acetonide insert on recurrence rates in noninfectious intermediate, posterior, or panuveitis: three-year results. Ophthalmology. 2020;127(10):1395-1404. doi:10.1016/j.ophtha.2020.04.001

3 Hamdan A, Sharma S, Chen C, et al. Imaging-based risk factors for rescue in uveitis patients treated with injectable fluocinolone acetonide. Poster presented at: The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting; May 1-4, 2022; Denver, CO.

4 Jaffe GJ, Foster CS, Pavesio CE, Paggiarino DA, Riedel GE. Effect of an injectable fluocinolone acetonide insert on recurrence rates in chronic noninfectious uveitis affecting the posterior segment: twelve-month results. Ophthalmology. 2019;126(4):601-610. doi:10.1016/j.ophtha.2018.10.033