Positive results seen in phase 2 trial of Aerie’s dexamethasone intravitreal implant
Aerie Pharmaceuticals announced positive topline results for a phase 2 clinical trial of AR-1105 in macular edema associated with retinal vein occlusion, according to a press release.
The two-stage trial evaluated two formulations of the dexamethasone intravitreal implant with different steroid release profiles. In the initial safety stage, five patients received the first clinical formulation, a 340 µg dexamethasone dose in an intravitreal injection. In the second stage, 44 patients were randomly assigned to receive either the first or second formulation.
Both formulations demonstrated positive results, measured by increased best corrected visual acuity and reductions in macular edema. The first formulation demonstrated earlier peak efficacy, while the second formulation showed a longer duration effect of up to 6 months.
The formulations were well-tolerated, and the study presented no unexpected safety findings.
“The profiles of the different cohorts demonstrate the flexibility of our PRINT sustained-release technology platform in enhancing the management and durability of treatment effects. This product candidate would be a welcome addition to currently available steroid treatments with its potential for 5 to 6 months of sustained efficacy,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release
New clinical trials of AR-1105 are not expected until the second half of 2021, after the company evaluates results in clinical trial programs for wet age-related macular degeneration, diabetic macular edema and dry eye.
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