The Opthea Ltd (ASX: OPT) share price opened higher on Wednesday after receiving an important regulatory waiver from the US FDA
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The Opthea Ltd (ASX: OPT) share price is up 8.39% to $1.55 this morning. The rise comes after receiving an initial Pediatric Study Plan (iPSP) waiver from the US Food and Drug Administration (FDA) for OPT-302.
Opthea is committed to improving vision in patients suffering from retinal eye diseases. OPT-302 is the company’s lead product candidate. The product also has the potential to address the unmet medical need within the eye disease market.
Another milestone for the Opthea share price
An iPSP is a pre-requisite for a marketing application of new medicine for a biopharmaceutical company in the US. Additionally, the iPSP provides the FDA with details regarding the company’s proposed strategy. In particular, for the investigation of a new medical product in a pediatric population.
On Wednesday, Opthea received an iPSP waiver for OPT-302. This applied to all subsets of the pediatric population (full pediatric age group from birth to <17 years) for the treatment of wet age-related macular degeneration (wet AMD), a leading cause of visual impairment in the developed world in people over the age of 50.
Wet AMD affects approximately 1 million people in the United States and 2.5 million in Europe. Furthermore, the company believes that the global aging population will result in a significant increase in the number of wet AMD cases. The disease affects central vision and the ability to see fine detail. Wet AMD is caused by abnormal growth and leakage of blood vessels. This occurs at the back of the eye, which results in degeneration of the retina and vision loss.
Comments from the CEO
The iPSP waver means Opthea will not have to conduct an additional study in the pediatric population. Opthea CEO, Dr. Megan Baldwin commented on the waiver:
The agreed iPSP waiver is an important regulatory milestone in the US that is required to be completed before Opthea is able to submit a marketing application for OPT-302 to the FDA. Opthea will continue the process to further fulfilling regulatory requirements by focusing on our pivotal Phase 3 clinical trials in adult patients that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD.
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Motley Fool contributor Kerry Sun has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.