June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
U.S. Phase 1 Study of Intravitreal Axitinib Implant (OTX-TKI) for Neovascular Age-related Macular Degeneration
Author Affiliations & Notes
  • Andrew A Moshfeghi
    Ophthalmology, University of Southern California Keck School of Medicine, Los Angeles, California, United States
  • Arshad M. Khanani
    Sierra Eye Associates, Reno, Nevada, United States
  • David Aaron Eichenbaum
    Retina Vitreous Associates of Florida, Saint Petersburg, Florida, United States
  • Charles Clifton Wykoff
    Retina Consultants of Texas, Houston, Texas, United States
  • Stephen Couvillion
    California Retina Consultants, Santa Barbara, California, United States
  • Samantha Xavier
    Florida Eye Clinic, Altamonte Springs, Florida, United States
  • Nathan Steinle
    California Retina Consultants, Santa Barbara, California, United States
  • Peter Kaiser
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Rabia Gurses Ozden
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Andrew Moshfeghi Allergan, ALIMERA, Regeneron, Regenxbio, Genentech, Novartis, Ocular Therapeutix, Pr3vent, Placid0, VALITOR, SCINEURO, OcuTerra, Waldo, Code C (Consultant/Contractor), Regeneron, Genentech, Novartis, Code F (Financial Support), Pr3vent, OptiSTENT, Placid0, VALITOR, WALDO, Ocular Therapeutix, Code I (Personal Financial Interest); Arshad Khanani Abbvie, AdverumBiotechnologies, AGTC, Alimera Sciences, Allergan, Apellis Pharmaceuticals, Arrowhead, Pharmaceuticals, AsclepiXTherapeutics, AvicedaTherapeutics, Bausch & Lomb , BroadWingBio, CholgeneTherapeutics, 4D Molecular Therapeutics, Eyepoint Pharmaceuticals, FronterraTherapeutics, Gemini Pharmaceuticals, Genentech, GraybugVision, Gyroscope Therapeutics, IVERIC bio, Janssen Pharmaceuticals, Kato Pharmaceuticals, KartosTherapeutics, Kodiak Sciences, Kriya Therapeutics, Ocular Therapeutix, Oculis, Ocuterra, Opthea, Oxurion, Novartis, Perfuse, PolyPhotonix, Ray Therapeutics, RecensMedical, Regeneron Pharmaceuticals, REGENXBIO, Roche, Stealth Biotherapeutics Therapeutics, Thea Pharma, UNITY Biotechnology, Vanotech, Code C (Consultant/Contractor), AdverumBiotechnologies, AnnexonBiosciences, Apellis Pharmaceuticals, AsclepiXTherapeutics, 4D Molecular Therapeutics, Gemini Pharmaceuticals, Genentech, GraybugVision, Gyroscope Therapeutics, IVERIC bio, Janssen Pharmaceuticals, Kodiak, Neurotech, NGM Biopharmaceuticals, Novartis, Ocular Therapeutix, Oculis, Ocuterra, Opthea, Oxurion, RecensMedical, REGENXBIO, Roche, UNITY Biotechnology, Code F (Financial Support); David Eichenbaum Alimera, Allegro, Allergan, Clearside, Dutch Ophthalmic, EyePoint, Genentech, Inc., Gyroscope, Kodiak, Notal Vision, Novartis, Orbit Biomedical, Ocular Therapeutix, Recens Medical, Regeneron, Code C (Consultant/Contractor), Alimera, Alkahest, Allergan, Chengdu, Clearside, Genentech, Inc., Iveric (Opthotech), Mylan, NGM, Novartis, Ophthea, Regeneron , Code F (Financial Support), Boston Image Reading Center, Clearside, Hemera, Network Eyecare, US Retina, Code I (Personal Financial Interest); Charles Wykoff Acucela, Adverum, Alimera Sciences, Allegro, Allergan, Apellis (C, S), Arctic Vision, Bausch and Lomb, Bayer, Chengdu Kanghong Biotechnologies, DORC , EyePoint, Genentech,Gyroscope, IVERIC Bio, Kodiak Sciences, Merck, NGM Biopharmaceuticals, Novartis, ONL Therapeutics, Opthea, Oxurion, Palatin, Polyphotonix, Recens Medical, Regeneron, RegenXBio, Roche, Takeda, Thea Open Innovation, , Code C (Consultant/Contractor), Adverum, Aerie Pharmaceuticals, Aldeyra, Apellis, Gemini Therapeutics, Genentech, Graybug Vision, IONIS Pharmaceutical, Kodiak Sciences, LMRI, Neurotech Pharmaceuticals, NGM Biopharmaceuticals, Novartis, Opthea, Outlook Therapeutics, Recens Medical, Regeneron, RegenXBio, Roche, Samsung Bioepis, Santen, Senju, Taiwan Liposome Company, Xbrane BioPharma, Code F (Financial Support); Stephen Couvillion Genentech, Code C (Consultant/Contractor), Ocular Therapeutix, Code F (Financial Support); Samantha Xavier Allegro Ophthalmics, Ocular Therapeutix, Code F (Financial Support); Nathan Steinle Alimera, Allergan, Apellis, Bausch and Lomb, Genentech, Inc., Novartis, Opthea, Oyster Point Pharma, Regeneron, Regenxbio, Roche, Vortex Surgical, Zeiss, Code C (Consultant/Contractor), Genentech, Inc., Novartis, Ocular Therapeutix, Regeneron, Regenxbio, Roche, Zeiss, Code F (Financial Support), Regeneron, Vortex Surgery, Code I (Personal Financial Interest); Peter Kaiser AbbVie/Allergan, Aerie, Aerpio, Alcon, Allegro, Annexon Biosciences, AsclepiX, Bayer, Bausch + Lomb, Biogen Idec, Boerenger Ingelheim, Carl Zeiss Meditec, Clearside, Eyevensys, Formycon/BioEq GmbH, Galecto, Galimedix, Glaukos, iRenix, jCyte, Kala, Kanghong, Kodiak, NGM Biopharmaceuticals, Novartis, Ocugenix, Ocular Therapeutix, Oculis, Regenexbio, Retinal Sciences, Roivant, Santen, SciFluor, Shire, Spark, Stealth, Takeda, Verana Health [Digisight], Code C (Consultant/Contractor); Rabia Gurses Ozden Adverum, Code C (Consultant/Contractor), Ocular Therapeutix, Code E (Employment)
  • Footnotes
    Support  Clinical trial sponsor: Ocular Therapeutix, Inc.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 936. doi:
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      Andrew A Moshfeghi, Arshad M. Khanani, David Aaron Eichenbaum, Charles Clifton Wykoff, Stephen Couvillion, Samantha Xavier, Nathan Steinle, Peter Kaiser, Rabia Gurses Ozden; U.S. Phase 1 Study of Intravitreal Axitinib Implant (OTX-TKI) for Neovascular Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2023;64(8):936.

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

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Abstract

Purpose : OTX-TKI is a novel, bioresorbable, hydrogel implant designed to deliver a potent tyrosine kinase inhibitor, axitinib, for 6 or more months and can potentially address challenges with current anti-VEGF therapy for neovascular age-related macular degeneration (nAMD). The study was designed to assess the safety, tolerability, and biological activity of a single OTX-TKI implant in nAMD patients.

Methods : Randomized, controlled, double-masked, multicenter, Phase 1 clinical trial in the United States. Neovascular AMD adult subjects who were previously treated with anti-VEGF intravitreal injections and were free of excess intraretinal and subretinal fluid were included in the study. Subjects were randomized 3:1 to receive either a single OTX-TKI 600µg implant on Day 0 and aflibercept 2mg at Month 1, or aflibercept 2mg Q8W. Incidence and severity of adverse events (AEs), changes in visual acuity (BCVA using ETDRS letters), central subfield thickness, and number of rescue injections (supplemental anti-VEGF injections) were assessed.

Results : The study enrolled 21 subjects (n=16 for OTX-TKI and n=5 for aflibercept). OTX-TKI was well tolerated with no reports of drug-related ocular or systemic serious AEs were reported in either group. Following dosing with OTX-TKI, BCVA and CSFT remained stable for at least 7 months with minimal changes from baseline. At Month 7, mean change in BCVA for OTX-TKI and aflibercept (-1.3 and -1.0 letters, respectively) and mean change in CSFT for OTX-TKI and aflibercept (+9.2 and +0.4 µm, respectively) were comparable. Eighty percent (80%) of OTX-TKI subjects did not receive rescue therapy for up to 7 months.

Conclusions : In this 7-month interim analysis, OTX-TKI produced a stable and sustained effect on BCVA and CSFT that was comparable to nAMD standard of care aflibercept Q8W. OTX-TKI was generally well tolerated with a favorable profile. The study is ongoing and follow-up continues to Month 12.

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

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