US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration.
Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD).
Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients.
Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end.
“The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss."
The company detailed how the process will involve a multi-centre parallel-group trial, based mainly out of US clinics, and with randomised subjects. The enrolled patients will receive either OTX-TKI, or Regeneron Pharmaceuticals’ Eylea (aflibercept).
A 2022 Global Data analysis found that the global market for age-related macular degeneration stood at around $9.2 billion and is expected to grow to $30.2 billion by 2031. It also found that 43.9% of the viable market was in North America.
Global Data is the parent company of Pharmaceutical Technology.
Dr. Arshad Khanani, principal investigator for the OTX-TKI pivotal Phase 3 trial, said: “OTX-TKI has shown the potential to reduce treatment burden while maintaining vision and anatomy for patients with wet AMD. The OTX-TKI pivotal trial design is unique as it is based on the latest FDA guidance for wet AMD.
