First Patient Dosed in OTX-TKI Trial for Wet AMD

Clinical trials are important tools in determining the safety, efficacy, and tolerability of new therapeutic options. So it is important to learn when patients are dosed, what those dosages are, and how treatments impact their disease states. According to a news release from late July 2021, the first patient was dosed in a Phase 1 clinical trial evaluating OTX-TKI (axitinib intravitreal implant) for patients with wet age-related macular degeneration (wet AMD). If this treatment is effective, it could offer a more durable treatment option than the current standards-of-care.

OTX-TKI

Developed by biopharmaceutical company Ocular Therapeutix, Inc., OTX-TKI is described as:

a bioresorbable hydrogel that contains TKI particles in an injectable fiber. OTX-TKI is designed to deliver drug to the target tissues for an extended duration of up to 12 months, thereby potentially extending the dosing interval from the 1-2 month frequency needed with the current standard of care.
Within this trial, researchers will evaluate a higher OTX-TKI dose: 600mg delivered in a single implant. Then this treatment will be compared to 2mg aflibercept, which must be given every 8 weeks, in previously treated patients who received anti-VEGF treatment. Altogether, 20 patients will enroll – 15 who will receive OTX-TKI and 5 who will receive aflibercept. In a previous study, OTX-TKI showed durability, efficacy, and tolerability. Now, researchers will evaluate whether this same response can be replicated.

Wet Macular Degeneration (wMD)

Overall, two forms of macular degeneration, an eye disease which causes vision loss, exist: wet and dry. Dry macular degeneration (dMD) makes up around 85-90% of cases, while wet macular degeneration (wMD or Wet AMD) makes up the rarer and more severe form. However, the wet form usually begins as dMD. In wMD, abnormal blood vessels leak fluid into the macula (part of the retina). As the retina becomes wet, vision loss occurs. Risk factors include older age, being obese, having a family history of wMD, smoking cigarettes, and being Caucasian. Typically, wMD symptoms come on suddenly and progress rapidly, causing irreversible vision loss in months if not treated. Once symptoms appear, these include:

  • Reduced central vision
    • Note: This may also manifest as a gray, black, or red spot in central vision.
  • Difficulty recognizing faces, reading (due to blurriness), or adjusting to low light
  • Visual distortions
    • Note: For example, this could include straight lines looking wavy or bent.
  • Decreased color brightness or intensity
  • Requiring brighter light to perform activities
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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