Ocugen, Inc., a leading biotechnology company dedicated to the development of gene and cell therapies and vaccines, recently revealed that its Phase 1/2 ArMaDa clinical trial for OCU410, a Modifier Gene Therapy designed to treat geographic atrophy, has received positive feedback from the Data and Safety Monitoring Board (DSMB).
Following this development, Ocugen's shares experienced a 4 percent surge, trading at $1.57 in Nasdaq's pre-market activity.
The DSMB has recently assembled and given the green light to continue with the medium dose for OCU410 in the dose-escalation phase of the trial. Building on this, Ocugen has announced the commencement of enrollment for the medium dose of OCU410.
In the existing Phase 1/2 clinical trial, three patients with geographic atrophy have been administered the treatment. Ocugen plans to deliver the medium dose of OCU410 to an extra three patients (part of Cohort 2), and the high dose to three more patients (forming Cohort 3) in the dose-escalation phase of the study.
Peter Chang, the DSMB Chair for the OCU410 clinical trial, stated, “The DSMB supports moving on to the medium dose phase for treating patients with geographic atrophy. Up until now, OCU410 has not been linked to any significant adverse events. This signifies a crucial step towards establishing the ideal dosing regime and marks a significant milestone for OCU410’s clinical development."
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