お知らせ • Jul 13
Ani Pharmaceuticals Announces Positive Six-Month Topline Data from Phase 4 Synchronicity Trial Evaluating Fluocinolone Acetonide Intravitreal Implant in Patients with Chronic Non-Infectious Uveitis
ANI Pharmaceuticals, Inc. announced positive topline data from its Phase 4, open-label, single-arm SYNCHRONICITY clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS). Both co-primary endpoints assessing mean change from baseline in best corrected visual acuity (BCVA) letter score as measured by ETDRS and mean change from baseline in central subfield thickness (CST) as measured by SD-OCT at 6 months in the intent-to-treat (ITT) population (n=108) were met with statistical significance. Patients in the ITT population had a mean change in baseline BCVA of +3.6 letters gained. SYNCHRONICITY (NCT05322070) was a prospective, Phase 4, open-label, single-arm, two year follow-up study conducted in the U.S. to evaluate the inflammatory control associated with fluocinolone acetonide intravitreal implant, 0.18 mg, designed to deliver a continuous low-dose corticosteroid, for the treatment of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. In the SYNCHRONICITY trial patients received fluocinolone acetonide intravitreal implant 0.18 mg as an intravitreal injection in the designated study eye and were followed for 24 months after treatment. Primary endpoints measured at 6 months were mean change from baseline in BCVA letter score in the study eye measured by ETDRS and mean change from baseline CST as measured by SD-OCT. Patients enrolled in the study had to have a diagnosis of active, recurrent, unilateral or bilateral NIU-PS with a duration of at least 3 months from initial diagnosis. The study population had a mean age of 64 years and the majority of participants were female (65%). The mean (SD) central subfield thickness (CST) was 505.7 (141.3) microns. Baseline BCVA in the study eye had a mean (SD) of 62.5 (11.6) ETDRS letters. At baseline, 69% of study participants had a history of ocular surgery prior to enrollment. However, patients were excluded from the study if they had ocular surgery within 12 weeks of Day 1 of the study. The most common adverse events reported were consistent with prior trials of fluocinolone acetonide intravitreal implant 0.18 mg. Study evaluated patients with chronic NIU-PS in the U.S. Most patients in the study were treated by retina specialists. Full results to be presented at an upcoming medical meeting. ILUVIEN is an intravitreal implant designed to release the corticosteroid fluocinolone acetonide in the eye for up to 36 months. ILUVIEN was approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 2025 FDA approved the consolidation of the labeling for two bioequivalent strengths of fluocinolone acetonide into one Prescribing Information for ILUVIEN, thereby expanding the ILUVIEN label to include an indication for the treatment of chronic NIU-PS. ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8. ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product. Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. For patients with non-infectious uveitis affecting the posterior segment, hypotony has been observed within 24 hours of injection and has resolved within 2 weeks. Patients should be monitored following the intravitreal injection. Patients may experience temporary blurred vision after injection of the implant. Prolonged use of corticosteroids may result in the development of glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be routinely monitored during the course of the treatment. The use of corticosteroids may result in posterior subcapsular cataract formation. The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of ophthalmic corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber. Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of ILUVIEN for diabetic macular edema include: cataract (82%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%), posterior capsule opacification (9%), eye irritation (8%), vitreous detachment (7%), conjunctivitis (4%), corneal oedema (4%), foreign body sensation in eyes (3%), eye pruritus (3%), ocular hyperaemia (3%), optic atrophy (2%), ocular discomfort (2%), photophobia (2%), retinal exudates (2%), anterior chamber cell (2%), and eye discharge (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: anemia (11%), headache (9%), renal failure (9%), and pneumonia (7%).