Ocugen completes dosing of GARDian3 trial for OCU410ST ahead of schedule
Ocugen have recently announced that they have completed enrolment and dosing in their pivotal phase 2/3 trial of OCU410ST ahead of schedule.
Ocugen have recently announced that they have completed enrolment and dosing in their pivotal phase 2/3 trial of OCU410ST ahead of schedule. The trial, known as GARDian3, involves 63 participants across 14 sites in the US, and is designed to evaluate the safety and efficacy of OCU410ST delivered through a single subretinal injection.
Participants will be enrolled in a 2:1 ratio to either the treatment group or to an untreated control group. This means that participants are randomly assigned to receive the treatment or the placebo, and the people who look at and measure the results don’t know which group each person was in. This helps to prevent their expectations from influencing how they judge the results.
Due to its mechanism, OCU410ST has the potential to work for participants with various genetic mutations in the ABCA4 gene resulting in Stargardt disease. This trial hopes to build on the promising early results observed in the phase 1 clinical trial, with the primary endpoint being a reduction in atrophic lesion size at 12-months. You can read more about the treatment and findings from the phase 1 clinical trial in our previous article here.
Ocugen also hope that data provided at the 12-month follow-up stage will be used to support the Biologics License Application, an important milestone in the regulatory process that demonstrates the necessary safety ad efficacy standards of a product are met. We look forward to hearing more exciting updates from Ocugen throughout the year as this trial progresses.