ANI Pharmaceuticals公布ILUVIEN葡萄膜炎Phase 4六个月积极数据

ANI Pharmaceuticals, Inc. (ANIP) announced positive six-month topline results from its Phase 4 SYNCHRONICITY trial evaluating ILUVIEN (fluocinolone acetonide intravitreal implant 0.18 mg) in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS).
Indication
Chronic non-infectious uveitis of the posterior segment (chronic NIU-PS) is a serious inflammatory eye condition that can lead to vision loss. ILUVIEN is designed to deliver sustained corticosteroid therapy directly to the eye, reducing inflammation and helping preserve vision in patients who often have limited treatment options.
Trial Design
The SYNCHRONICITY study was an open-label, single-arm Phase 4 trial conducted in the U.S. with 108 patients treated primarily by retina specialists. The trial assessed both efficacy and safety of the fluocinolone acetonide intravitreal implant 0.18 mg over six months.
Key Findings
The study met both co-primary endpoints with statistical significance:
- Best corrected visual acuity (BCVA): Patients gained a mean of +3.6 letters from baseline at six months (p<0.0077).
- Central subfield thickness (CST): Patients showed a mean reduction of -157.5 microns at six months (p<.0001).
These improvements highlight meaningful gains in vision and reduction of retinal swelling for patients with chronic NIU-PS.
Safety Profile
Adverse events were consistent with prior trials of the implant. In the safety population, 29% of patients experienced treatment-related events. The most common were ocular hypertension in 6% and cataract in 5%. Additionally, 18% of patients had an intraocular pressure increase of =25 mmHg, and 7% required laser or surgical intervention to lower eye pressure.
Company Commentary
"We are encouraged by the positive results from the SYNCHRONICITY trial, which continue to support the use of fluocinolone acetonide intravitreal implant in patients with chronic NIU-PS being treated by retina specialists," said Nikhil Lalwani, President and Chief Executive Officer of ANI Pharmaceuticals. "We look forward to sharing detailed results at medical conferences and continuing to engage the retina community."
Next Steps
Full results and additional analyses will be presented at upcoming medical meetings in the fourth quarter of 2026.
ANIP has traded between $62.61 and $99.50 over the past year. The stock closed Friday's trading (July 10, 2026) at $82.07, down 2.04%.
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