ANI Pharmaceuticals reports Phase 4 eye‑implant trial met both endpoints
The uncontrolled SYNCHRONICITY study reported a 3.6-letter vision gain at six months, with improvements maintained through two years.
Theo Marchetti
In the United States, the Phase 4 SYNCHRONICITY eye-implant trial met both six-month endpoints in results presented Oct. 9 in New Orleans. ANI Pharmaceuticals, Inc. NASDAQANIP reported a mean vision gain of 3.6 letters in its 108-patient intent-to-treat analysis in Monday's release.
Mean central retinal thickness fell by 157.5 microns at six months, while both measures remained improved at 24 months, ANI said. The open-label, single-arm study compared patients with their starting measurements, so it cannot establish superiority over another treatment.
ANI develops and sells rare disease medicines, generics and established brands. The results add follow-up evidence for its ophthalmology franchise, where ILUVIEN net revenue fell 16.1 per cent to US$18.7 million in the quarter ended June 30, primarily because of international shipment timing.
ANI shares closed at US$73.89 on Nasdaq at 4:00 p.m. EDT on Oct. 9, according to NASDAQANIP on Google Finance. That close preceded the Oct. 12 release, issued at 6:55 a.m. EDT, and does not measure a reaction to Monday's announcement.
Improvements Persisted Through Two Years
SYNCHRONICITY evaluated a 0.18 milligram fluocinolone acetonide implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients had previously responded to steroid therapy and received one implant in a designated study eye.
The NCT05322070 registry record describes an unmasked study with one treatment group and no comparator. Its two primary measures were change in best corrected visual acuity, measured in letters, and central subfield thickness, measured by optical imaging.
At six months, the reported vision gain had a P value of 0.0077. The retinal thickness reduction had a P value below 0.0001.
At 24 months, mean vision gain was 5.5 letters and mean retinal thickness reduction was 171.2 microns. ANI reported no recurrence of non-infectious inflammation in 86 of the 108 study eyes over that period.
Treatment-related adverse events occurred in 29 per cent of patients, with ocular hypertension and cataract among the most common. Pressure-lowering laser or surgery was required in 7.4 per cent of patients, while cataract surgery was reported in 14.8 per cent of study eyes.
"SYNCHRONICITY followed patients with chronic NIU-PS for two years after a single implant," principal investigator David R.P. Almeida said in the release.
ILUVIEN Already Has A Combined Label
ANI's Aug. 7 earnings release said ILUVIEN had a combined U.S. label covering diabetic macular edema and non-infectious posterior segment uveitis. The company transitioned U.S. promotional efforts from YUTIQ to ILUVIEN during the second quarter of 2025, with no YUTIQ sales in the June 2026 quarter.
A related development comes from Roche Holding AG SWXROP OTCMKTSRHHBY. In its Oct. 10 announcement, Roche said the FDA had accepted its application for vamikibart, an investigational non-steroid treatment for uveitic macular edema.
Roche's Phase 3 studies used sham comparators. Neither company's reviewed results compare the two medicines directly.
Read more: Roche reports vamikibart vision gains through week 52 in two trials
The SYNCHRONICITY material reviewed gives no date for another readout or a regulatory filing. In the related uveitic macular edema program, Roche expects the FDA's approval decision by July 2027.
