Phase 3 initiation
Amp Volatility Score
Catalyst Info & Data Links
TITLE: AR-1105 for macular edema associated with retinal vein occlusion - Phase 3
Phase 2b - Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
WHAT IS THE NEXT CATALYST EVENT?
Phase 3 To be Initiated
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Aerie is currently exploring sustained-release drug delivery technology to treat diabetic macular edema (DME). Our product candidate AR-1105 is an intravitreal, fully biodegradable PRINT®-manufactured implant that releases the steroid dexamethasone. Our expectation is that this implant will provide a six-month duration of action, thereby reducing treatment burden relative to other treatments for DME.1
We filed an Investigational New Drug (IND) application for AR-1105 (Dexamethasone Intravitreal Implant) in December 2018. The FDA has reviewed the IND and it is now in effect. A Phase 2 study in the treatment of macular edema due to retinal vein occlusion (RVO) was initiated in March 2019.
Nov 5, 2020 quarterly call
"We also remain excited about the recently announced topline Phase 2 results for AR-1105, which indicated up to six months of sustained efficacy for patients with macular edema associated with retinal vein occlusion, a significantly differentiated profile for a retinal steroid implant. The potential of AR-1105 in the United States and especially European retina markets could be quite meaningful and we are evaluating the clinical and regulatory path in both markets."
DME, diabetic macular edema, dexamethasone intravitral implant, RVO, retinal vein occlusion, dexamethasone, intravitreal implant
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