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.
Dr. Michael Singer discusses topline results from the AR-1105 (dexamethasone intravitreal implant) Phase 2 clinical trial in patients with macular edema due to retinal vein occlusion which were presented at the American Society of Retina Specialists.
About Diabetic Macular Edema
DME is an accumulation of fluid in the macula resulting from leaking blood vessels. DME is a manifestation of diabetic retinopathy, which causes damage to retinal vessels and vision impairment. Driven by rising rates of diabetes, the number of cases of diabetic retinopathy in the United States is expected to nearly double by 2050, rising from 7.7 million to 14.6 million.1 Approximately half of all people with diabetic retinopathy will develop DME.2
Sustained Release Steroid Implant
AR-1105 is an intravitreal, fully-bioerodible PRINT®-manufactured implant that releases the corticosteroid dexamethasone, a widely-used and well characterized anti-inflammatory drug. AR-1105 has not been approved by the U.S. Food and Drug Administration (FDA). 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
Aerie filed an Investigational New Drug (IND) application for AR-1105 (Dexamethasone Intravitreal Implant) in December 2018. A Phase 2 study (AR-1105-CS201) in the treatment of macular edema secondary to retinal vein occlusion (RVO) was initiated in March 2019. Conducted at 19 centers in the United States, the study objective was to evaluate two clinical formulations of AR-1105, CF-1 and CF-2 (each containing 340 µg dexamethasone), with different release profiles. Topline results of this study were reported in July 2020.
A total of 49 patients completed the study. Both formulations demonstrated sustained treatment effects in best corrected visual acuity (BCVA) and reductions in macular edema. Peak efficacy was observed earlier with CF-1, while CF-2 demonstrated a longer overall duration of effect of up to six months.1
Both formulations were well tolerated with no unexpected safety findings. Adverse events were consistent with other corticosteroid treatments and intravitreal injection procedures.1
Based on these positive results, Aerie is planning a Phase 3 clinical program in the United States and Europe.
- Data on file. Aerie Pharmaceuticals, Inc.