Paul Smith shares an update on Orasis Pharmaceutical's CSF-1 drug and what to expect this year.
Paul Smith, president and chief operating officer at Orasis Pharmaceuticals, shares a pipeline update on what to expect for the company and its CSF-1 drug this year.
Editor's note: This transcript has been edited for clarity.
Hello, I'm Paul Smith, president and chief operating officer at Orasis Pharmaceuticals. It's a pleasure to join you here from the SECO meeting in Atlanta.
This is an exciting meeting for us, because we just announced a few short days ago, a major milestone for the company. And that was the FDA acceptance of our submission for CSF-1, which included the announcement of our PDUFA date later this year. And I think, you know, as anyone involved in drug development would tell you, this is a non trivial step on the path toward approval and commercialization. So we're very excited and all eagerly awaiting that October date later this year.
And while this is a major milestone for the company, it's not done without partnership from the eye care community. And so we are truly excited about the work we've been doing together with optometry and ophthalmology as we have worked over these last few years to develop an optimized formulation for presbyopes. That means not only providing a product that will allow them to take a break from their glasses, it also means designing something that truly represents that patient and their needs.
We also have the opportunity to share at the OIS meeting this week, the idea that formulation really matters. And as we're pioneering this new space, we were able to share and remind some of the audience who've been following us that CSF-1 is an optimized formulation of low dose pilocarpine at 0.4%. It's formulated preservative-free in a vehicle that is at a near neutral pH and also includes multiple lubricating agents. So that's a product that truly balances efficacy, safety, and comfort, and will help them meet presbyopes where they are.
It's also exciting that our phase 3 data continue to be presented at various meetings and Dr. Jade Coats is presenting data this week from our NEAR-1 study, which showed that CSF-1 is truly a drug that is going to benefit a broad range of patients who may want to manage their vision in different ways. Those data are going to show that the CSF-1 performs and as early as 20 minutes after the first dose and provide significant results out to 8 hours.
Now, the relevance of these data and a lifestyle category again is that different patients are going to want to manage their vision in different ways. So whether you have a patient that is simply looking for a break from the readers for a specific social activity or occasion, or you have somebody who wants to extend that effect out to a full day, CSF-1 will truly meet them where they are. So we look forward to keeping the eye care market informed and are very excited to be next in this new and expansive category.