Alimera Sciences, Inc. has completed enrollment for its phase 4 Synchronicity study, which is evaluating the safety and efficacy of YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for the treatment of chronic noninfectious uveitis (NIU) and related intraocular inflammation.
Refresh me on Alimera.
Founded in 2003 and based in Alpharetta, Georgia, the global biopharmaceutical company specializes in the commercialization and sales of prescription ophthalmic pharmaceuticals, with a primary focus given to diseases affecting the retina.
Of note, Alimera’s ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg—approved by the FDA in 2014—is indicated for the treatment of diabetic macular edema (DME) and marketed with an indication to treat noninfectious posterior uveitis in 17 European countries (but not currently in the U.S..)
Now let’s talk YUTIQ.
YUTIQ was approved by the FDA in 2018 to treat chronic NIU affecting the posterior segment of the eye. As a sustained release fluocinolone acetonide intravitreal implant, it was designed to be injected into the retina using Alimera’s proprietary continuous microdosing technology.
The intended effect: to deliver a sustained release of fluocinolone for up to 36 months.
Also of note, the formulation was originally developed and approved by EyePoint Pharmaceuticals before Alimera acquired the U.S commercial rights in May 2023 (see our coverage here).
Any precautions to take?
The formulation contains a corticosteroid designed to be delivered under aseptic conditions.
According to Yutiq’s prescribing information (PI), patients should be monitored for potential intraocular pressure (IOP) elevation and endophthalmitis following injection.
And this clinical study?
The phase 4 Synchronicity study (NCT05322070) is a prospective, multicenter, open-label, 2-year follow-up clinical trial that has thus far enrolled 110 patient eyes at 25 sites across the United States.
Participants in the study would receive an intravitreal injection of YUTIQ in their designated study eye, with a treatment period of 36 months (and data capture for the first 24 months of treatment).
Talk about the participants.
Participants (aged 18+) must be diagnosed with chronic NIU and related intraocular inflammation, and have responded to previous steroid therapy, according to Clinical Trials.
They must also have a best corrected visual acuity (BCVA) of the study eye 35-75 letters on the ETDRS chart (Snellen range 20/30 to 20/200).
See here for the full inclusion and exclusion criteria.
What’s being measured?
Per Alimera, the primary outcome measure includes the mean change from baseline in BCVA letter score in the study eye, as measured by:
- ETDRS at Month 6
- Mean change from baseline central subfield thickness (CST) at Month 6
Any secondary endpoints?
Quite a few…
- Time to recurrence of NIU inflammation in the study eye
- Presence of vascular leakage
- At Months 1, 3, 6, 12, 18, and 24
- Number of patients with resolution of macular edema
- At Months 1, 3, 6, 12, 18, and 24
- Mean change from baseline in BCVA letter score
- At Day 14, Months 1, 3, 12, and 18
- Mean change from baseline in CST
- At Months 1, 3, 12, 18, and 24
When can we expect results?
According to Clinical Trials, the study is slated to conclude by November 2025. Topline data will likely be released before then, though, so stay tuned!