ANI Pharmaceuticals Announces Positive Six-Month Topline Data from the Phase 4 Open-Label, Single-Arm SYNCHRONICITY Trial Evaluating Fluocinolone Acetonide Intravitreal Implant in Patients with Chronic Non-Infectious Uveitis
ANI Pharmaceuticals reported positive topline data from the Phase 4 SYNCHRONICITY trial for its Fluocinolone Acetonide Intravitreal Implant, meeting both co-primary endpoints with statistical significance. The trial demonstrated a mean improvement of +3.6 letters in best corrected visual acuity and a mean reduction of -157.5 microns in central subfield thickness at six months in the intent-to-treat population.
Key figures
- Phase Of Trial
- Phase 4
- N
- 108
- P value cst
- <0.0001
- P value bcva
- <0.0077
- Cataract rate
- 5%
- Cst change microns
- -157.5
- Bcva change letters
- 3.6
- Iop increase 25mmhg rate
- 18%
- Ocular hypertension rate
- 6%
- Treatment related ae rate
- 29%
- Surgical iop intervention rate
- 7%
AI analysis
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