June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Phase 1 Study of an Intravitreal Axitinib Hydrogel-based Implant for the Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
Author Affiliations & Notes
  • James Gilbert Wong
    Strathfield Retina Clinic, Strathfield, New South Wales, Australia
  • Andrew Chang
    Sydney Retina Clinic, Sydney, New South Wales, Australia
  • Robyn H Guymer
    CERA, Melbourne, Victoria, Australia
  • Sanjeewa Wickremasinghe
    CERA, Melbourne, Victoria, Australia
  • Erin Reilly
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Nicki Bell
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Srilatha Vantipalli
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Andrew A Moshfeghi
    Roski Eye Institute, University of Southern California, Los Angeles, California, United States
  • Michael H Goldstein
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   James Wong, Ocular Therapeutix (F); Andrew Chang, Ocular Therapeutix (F); Robyn Guymer, Ocular Therapeutix (F); Sanjeewa Wickremasinghe, Ocular Therapeutix (F); Erin Reilly, Ocular Therapeutix (E); Nicki Bell, Ocular Therapeutix (E); Srilatha Vantipalli, Ocular Therapeutix (E); Andrew Moshfeghi, Allegro (C), Allegro (F), Allergan (C), Genentech (C), Genentech (F), Graybug (C), Novartis (F), Novartis (C), Ocular Therapeutix (C), Ocular Therapeutix (I), OptiSTENT (I), Placid0 (I), Pr3vent (C), Pr3vent (I), Regeneron (C), Regeneron (F); Michael Goldstein, Ocular Therapeutix (E)
  • Footnotes
    Support  Ocular Therapeutix, Inc
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 218. doi:
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      James Gilbert Wong, Andrew Chang, Robyn H Guymer, Sanjeewa Wickremasinghe, Erin Reilly, Nicki Bell, Srilatha Vantipalli, Andrew A Moshfeghi, Michael H Goldstein; Phase 1 Study of an Intravitreal Axitinib Hydrogel-based Implant for the Treatment of Neovascular Age-Related Macular Degeneration (nAMD). Invest. Ophthalmol. Vis. Sci. 2021;62(8):218.

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

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Purpose : OTX-TKI, an intravitreal, bioresorbable, hydrogel-based implant, is designed to deliver the small molecule tyrosine kinase inhibitor, axitinib, in a sustained-release formulation to the vitreous & can potentially address the need for a novel treatment approach for nAMD that provides a longer duration of action. Here we report the preliminary safety, tolerability & biological activity of OTX-TKI in subjects with nAMD.

Methods : Prospective, multi-center, open-label, dose escalation Phase 1 study is ongoing. Subjects with nAMD (treatment-naïve or with a history of anti-VEGF therapy) were eligible to receive intravitreal placement of OTX-TKI. Three cohorts were evaluated: Cohort 1: 200 µg (n=6); Cohort 2: 400 µg (n=7); Cohort 3 (enrolling): 3a) 600 µg (n=5/6) & 3b) 400 µg + anti-VEGF induction therapy (n=2/6). Assessments included: Spectral-domain optical coherence tomography (SD-OCT) imaging to assess central subfield thickness (CSFT), best-corrected visual acuity (BCVA), & adverse event collection. Assessments were performed at baseline, day 0 (injection), days 3, 7, 14, & continued monthly until implants were no longer visible.

Results : No ocular serious adverse events have been reported to date (200 µg: 9-10.5 months; 400 µg: 12+ months; 600 µg: 4.5 months; 400 µg + Anti-VEGF: 3 months ongoing follow-up). No changes in intraocular pressure were observed in any subject & no subject required steroids. CSFT was noted to remain mostly stable in the 200 µg group. In the 400 & 600 µg groups, many subjects showed a decrease in CSFT & demonstrated a clinically meaningful reduction in intraretinal &/or subretinal fluid by 2 months. Reduction was maintained for up to 13 months in one subject in the 400 µg group, while in the 600 µg group, up to 4.5 months (only subject to reach this time point so far). Implants exhibited little movement in the vitreous & were generally no longer visible after 9 - 10.5 months (200 µg).

Conclusions : OTX-TKI appears to be generally well-tolerated to date with a favorable safety profile. Preliminary signs of biological activity, as evidenced by a decrease in CSFT in the 400 µg & 600 µg groups by two months, has been observed in many subjects with durability up to 13 months. Minimal movement & consistent resorption of implants has been observed. Study is still enrolling, and additional follow-up of current dose groups is ongoing.

This is a 2021 ARVO Annual Meeting abstract.


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