ANI Pharmaceuticals reports two‑year positive results from Phase 4 uveitis implant trial
ANI Pharmaceuticals announced that its Phase 4 SYNCHRONICITY trial of the fluocinolone acetonide intravitreal implant met both co‑primary endpoints in patients with chronic non‑infectious uveitis affecting the posterior segment. Visual acuity improved by 3.6 ETDRS letters at six months and 5.5 letters at 24 months, while central subfield thickness fell by 157.5 µm and 171.2 µm respectively. Over the 24‑month follow‑up, 79.6% of treated eyes showed no recurrence of inflammation. The safety profile was consistent with prior studies, with ocular hypertension and cataract as the most common adverse events.
Why it matters
The company says the data reinforce the clinical value of ILUVIEN for chronic NIU‑PS, which could support broader adoption by retina specialists and drive future sales. Investors may view the results as a catalyst for the stock, as reflected by a 2.65% price gain after the announcement.
Key facts
- 1The trial enrolled 108 patients in the United States. stocktitan.net
- 2Mean change from baseline in BCVA was +3.6 letters at month 6. stocktitan.net
- 3Mean change from baseline in BCVA was +5.5 letters at month 24. stocktitan.net
- 4Mean change from baseline in CST was –157.5 microns at month 6. stocktitan.net
- 5Mean change from baseline in CST was –171.2 microns at month 24. stocktitan.net
- 679.6% of study eyes experienced no recurrence of non‑infectious inflammation over 24 months. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.