June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
AR-14034 SR Implant Inhibits Retinal Vascular Leakage In A VEGF Challenge Model For Up To 12 Months
Author Affiliations & Notes
  • Meredith Weksler
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Alan McDougal
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Stuart Williams
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Tyler Pegoraro
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Ed Randles
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Mitchell A. deLong
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Casey C Kopczynski
    Aerie Pharmaceuticals Inc, Durham, North Carolina, United States
  • Footnotes
    Commercial Relationships   Meredith Weksler Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment); Alan McDougal Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment); Stuart Williams Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment); Tyler Pegoraro Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment); Ed Randles Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment); Mitchell deLong Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment); Casey Kopczynski Alcon (formerly Aerie Pharmaceutical, Inc), Code E (Employment)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2114. doi:
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      Meredith Weksler, Alan McDougal, Stuart Williams, Tyler Pegoraro, Ed Randles, Mitchell A. deLong, Casey C Kopczynski; AR-14034 SR Implant Inhibits Retinal Vascular Leakage In A VEGF Challenge Model For Up To 12 Months. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2114.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : VEGF challenge models are routinely used to assess potential therapies for Diabetic Macular Edema (DME) and neovascular age-related macular degeneration (nAMD). Current clinical treatments, in particular anti-VEGF immunotherapy, are effective, yet require frequent intravitreal (IVT) injections to maintain the optimal therapeutic effect. Two species, rabbit and miniature swine were used to evaluate a preclinical extended-release anti-VEGF therapy, AR-14034 SR Implant. The implant delivers the small molecule drug axitinib, an inhibitor of all isoforms of the VEGF receptor.

Methods : AR-14034 SR Implants were delivered IVT OU to rabbits and miniature swine, and either placebo-injected or naïve animals were utilized as controls. In the rabbit, three dose levels were evaluated at 1 and 2 months, and a single dose level was evaluated for further duration of effect at 3, 6, 9, and 12 months. In the miniature swine, two dose levels were evaluated at day 41. To evaluate efficacy of the implant, VEGF165 was administered IVT OU to induce retinal blood vessel leakage which was quantified using fluorescein angiography in both species. Retinal vessel leakage was scored in a masked fashion on a scale from 0-4.

Results : In the rabbit, all dose levels of the AR-14034 SR Implant provided significantly reduced retinal vessel leakage compared to control eyes at the 1- and 2-month timepoints. The single dose level in rabbits demonstrated statistically significant reductions in retinal vessel leakage following VEGF165 challenge at all timepoints out to 12 months. In the miniature swine, both implant dose levels significantly reduced retinal vessel leakage at day 41.

Conclusions : These studies demonstrate the potential of AR-14034 SR Implant as a long-term treatment for nAMD and DME.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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