June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Safety and Tolerability Study of Suprachoroidal Injection CLS-AX in Neovascular AMD Patients with Persistent Activity Following Anti-VEGF Therapy (OASIS, NCT04626128; Extension Study NCT NCT05131646)
Author Affiliations & Notes
  • Dennis M Marcus
    Southeast Retina Center, Augusta, Georgia, United States
  • Allen Hu
    Cumberland Valley Retina Consultants, Hagerstown, Maryland, United States
  • Mark Barakat
    Retinal Consultants of Arizona, Phoenix, Arizona, United States
  • David M Brown
    Retina Consultants of Texas, Houston, Texas, United States
  • Rahul N Khurana
    Northern California Retina Vitreous Associates Inc, Mountain View, California, United States
  • Joel Pearlman
    Retinal Consultants Medical Group, Sacramento, California, United States
  • Charles Clifton Wykoff
    Retina Consultants of Texas, Houston, Texas, United States
  • Thomas A Ciulla
    Clearside Biomedical Inc, Alpharetta, Georgia, United States
    Midwest Eye Institute, Indianapolis, Indiana, United States
  • Footnotes
    Commercial Relationships   Dennis Marcus Regenxbio, Genentech/Roche, Regeneron, Clearside Biomedical, Vial, Coherus, Vantage Biosciences, Code C (Consultant/Contractor), Allergan, Amgen, Boehringer Inglheim, Alcon, Kalvista, Ionis, Xplore, Mylan, Samsung, Novartis, Opthea, Chenghdu, Clearside Biomedical, Iveric, Outlook, Gemini, Genentech, Graybug, Topcon, Optos, Gyroscope, Stealth Spiam, Apellis, Roche, Novartis, Xplore, Regenxbio, Kodiak, Zeiss, Annexon, Oculis, Alexion, Oxurion, Hengenix, Rezolute, Regeneron, Code F (Financial Support); Allen Hu Clearside Biomedical, Code C (Consultant/Contractor), Clearside Biomedical, Code F (Financial Support); Mark Barakat Clearside Biomedical, Code C (Consultant/Contractor), Clearside Biomedical, Code F (Financial Support); David Brown Clearside Biomedical, Code C (Consultant/Contractor), Clearside Biomedical, Code F (Financial Support); Rahul Khurana Apellis, Bausch + Lomb, Genentech, NGM Biopharmaceuticals, Opthea, Code C (Consultant/Contractor), Apellis, Clearside Biomedical, EyePoint, Genentech, NGM Biopharmaceuticals, Opthea, Oxurion, Regenxbio, Code F (Financial Support); Joel Pearlman Clearside Biomedical, Code C (Consultant/Contractor), Clearside Biomedical, Code F (Financial Support); Charles Wykoff Clearside Biomedical, Code C (Consultant/Contractor), Clearside Biomedical, Code F (Financial Support); Thomas Ciulla Clearside Biomedical, Code E (Employment), Clearside Biomedical, Code I (Personal Financial Interest)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 728. doi:
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      Dennis M Marcus, Allen Hu, Mark Barakat, David M Brown, Rahul N Khurana, Joel Pearlman, Charles Clifton Wykoff, Thomas A Ciulla; Safety and Tolerability Study of Suprachoroidal Injection CLS-AX in Neovascular AMD Patients with Persistent Activity Following Anti-VEGF Therapy (OASIS, NCT04626128; Extension Study NCT NCT05131646). Invest. Ophthalmol. Vis. Sci. 2023;64(8):728.

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

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Abstract

Purpose : To assess the safety and tolerability of a single dose of CLS-AX (axitinib injectable suspension), a tyrosine kinase inhibitor, for suprachoroidal injection in patients with active subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) after anti-VEGF standard of care therapy.

Methods : Eligible nAMD patients had undergone ≥ 2 previous injections of an intravitreal anti-VEGF agent in the preceding 4 months, with reading center confirmation of persistent active disease, and demonstrated stable visual acuity. Eyes received intravitreal aflibercept 2 mg at the first visit, then received 1 dose of suprachoroidal CLS-AX 1 month later, with monthly follow-up for 3 months in the primary study (OASIS) and up to a total of 6 months including the Extension Study. Criteria for additional treatment with aflibercept were: loss from best measurement of ≥ 10 letters in BCVA with exudation, increase in central subfield thickness (CST) >75 microns, or a vision-threatening macular hemorrhage.

Results : Four dose-escalating cohorts (0.03 mg, n=6; 0.1 mg, n=5; 0.5 mg, n=8; 1.0 mg, n=8) were enrolled with a mean age 81 years, mean duration of nAMD diagnosis 54 months, and mean 29.9 prior anti-VEGF injections. In all cohorts, there were no serious adverse events, no treatment emergent adverse events related to study treatment, no dose limiting toxicities, and no adverse events related to inflammation, vasculitis or vascular occlusion. In cohorts 3 and 4, in OASIS to the 3-month timepoint (n=16), there was a 73% reduction in treatment burden, and in the ongoing Extension Study (interim data as of 10/27/22, n=12), there was a 90% reduction in treatment burden from the average monthly injections before CLS-AX. In cohorts 3 and 4 from the ongoing Extension Study, the injection free rate for supplemental aflibercept treatment was 88% up to month 5 (7/8 patients not receiving additional therapy) and 75% to month 6 (3/4 of patients not receiving additional therapy). Through 6 months, stable mean BCVA and anatomic signs of biological effect, including stable mean CST, were observed.

Conclusions : Suprachoroidal CLS-AX was safe and well-tolerated, with signs of biologic effect and durability in anti-VEGF treatment experienced nAMD patients with persistent activity.

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

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