Aerie Pharmaceuticals reported positive topline results for the company’s phase 2 clinical trial evaluating AR-1105 (dexamethasone intravitreal implant) in patients with macular edema associated with retinal vein occlusion.
AR-1105 Phase 2 Highlights
- The phase 2 clinical trial (AR-1105-CS201) was conducted at 19 centers in the United States. A total of 49 patients completed the study.
- The objective of the phase 2 clinical trial was to evaluate two formulations of AR-1105, clinical formulation #1 (CF-1) and clinical formulation #2 (CF-2) with different steroid release profiles. The clinical trial was conducted in two stages. In the initial safety stage, five patients were enrolled in a single cohort to receive CF-1, delivering a 340µg dose of dexamethasone in a single intravitreal injection. In stage 2, 44 patients were randomized 1:1 to receive either CF-1 or CF-2.
- The results demonstrated positive and sustained treatment effects with both formulations as shown by increases in best corrected visual acuity 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 6 months.
- Both formulations, CF-1 and CF-2, were well tolerated with no unexpected safety findings.
- Adverse events were consistent with other corticosteroid treatments and intravitreal injection procedures.
- Further details will be provided at an upcoming ophthalmology conference.
“The results of this study are very exciting. The formulation of AR-1105 appears to indicate that this therapy candidate may have the potential to deliver a long-acting treatment for patients with macular edema secondary to retinal vein occlusion,” Michael Singer, MD, Director of Clinical Research at Medical Center Ophthalmology Associates and Clinical Professors of Ophthalmology at the University of Texas Health Science Center in San Antonio, said in a company news release.
“We are very pleased with the AR-1105 clinical trial results, our first successful clinical trial from our retina program. 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 five to 6 months of sustained efficacy. Additionally, achieving up to six months of sustained efficacy is an important hurdle for Aerie as it would help validate the broad potential of our sustained release technology,” said Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie. “As we have previously stated, we do not plan to initiate any new clinical trials for this product candidate until the second half of 2021, after we have seen the results of our other clinical trial programs, including our AR-13503 sustained release implant for wet age-related macular degeneration and diabetic macular edema, and AR-15512 for dry eye. In the interim, we plan to discuss the results with retina specialists as well as the regulatory agencies in both the United States and the European Union to determine the optimal path forward for AR-1105.”
The product candidate AR-1105 is a bioerodible implant that, if approved, is designed to steadily release the steroid dexamethasone over a 6-month period. It is administered by intravitreal injection, a commonly used, in-office treatment method. In addition to its duration of effect, AR-1105 offers the potential for a favorable safety profile based on peak drug levels. The market for retinal disease therapeutics totals nearly $7 billion in the United States and $4 billion in Europe.