- Opthea (OPT) has received an initial Pediatric Study Plan (iPSP) waiver from the U.S. Food and Drug Administration (FDA) for OPT-302
- OPT-302 is a treatment against wet age-related macular degeneration
- As part of the regulatory review process, biopharmaceutical companies usually need to submit a iPSP
- Opthea has received the waiver from the FDA for all subsets of the paediatric population
- On the market this morning, Opthea is up 11.5 per cent and is trading at $1.60 per share
Opthea (OPT) has received an initial Pediatric Study Plan (iPSP) waiver from the U.S. Food and Drug Administration (FDA) for OPT-302.
OPT-302 is a treatment against wet age-related macular degeneration (AMD), a form of macular degeneration that causes sight-loss in the due to blood vessels growing under the retina.
Notably, the company’s lead candidate is currently in phase-three clinical development.
As part of the regulatory review process, biopharmaceutical companies that are planning to submit a marketing application of a new medicine with the FDA are required to provide an iPSP. The iPSP shows the company’s proposed strategy for the investigation of the new medicinal product in the pediatric population.
A waiver in developing an iPSP for certain conditions may be agreed to by the agency.
Opthea has received the waiver from the FDA for all subsets of the paediatric population for the treatment of wet AMD.
“The agreed iPSP waiver is an important regulatory milestone in the U.S. that is required to be completed before Opthea is able to submit a marketing application
for OPT-302 to the FDA,” CEO Dr Megan Baldwin said.
“Opthea will continue the process to further fulfilling regulatory requirements by
focusing on our pivotal phase three clinical trials in adult patients that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD,” he added.
On the market this morning, Opthea is up 11.5 per cent and is trading at $1.60 per share at 12:43 pm AEDT.