The 12-week trial demonstrated that we had visual acuity improvements in both study arms across each study visit and improving greater at each visit.
Welcome back for another Virtual Investor, What This Means segment featuring Outlook Therapeutics. My name is Janene Thomas, and I am CEO of JTCIR, and I will be moderating. I am very pleased to be joined by Dr. Jennifer Kissner. She is Senior Vice President of Clinical and Regulatory Affairs at Outlook Therapeutics. Welcome, Jennifer.
Thank you, Janene. Happy to be here.
Before we get started, I just want to inform our audience that Outlook Therapeutics is publicly listed and trades on Nasdaq under the ticker OTLK. During today's discussion, the company will be making forward-looking statements. I encourage everyone to view the company's website at outlooktherapeutics.com for SEC filings and the latest information. For our audience, Outlook Therapeutics recently announced that an analysis of the NORSE-8 data at week 12 showed ONS-5010 achieved a mean change in BCVA of 5.5 letters for ONS-5010 compared to 6.5 letters for ranibizumab. This was statistically non-inferior with a p-value of 0.0043. With that in mind, Jennifer, can you help us understand these 12-week data and how they compare to the previous data released in December at week eight?
Thanks, Janene. Appreciate the question. So, you'll recall that the NORSE-8 study is a phase three non-inferiority study that was requested by the FDA in order to provide a second adequate well-controlled trial of ONS-5010 to demonstrate safety and efficacy of the product. So, our recent release was of the complete data set from this 12-week trial. It was designed as a 12-week trial with an eight-week primary endpoint for efficacy. But the 12-week trial demonstrated that we had visual acuity improvements in both study arms across each study visit and improving greater at each visit. So, the two study arms were also non-inferior at week four and week 12 and narrowly missed the non-inferiority margin at week eight. So, what this means in context is that we have a trial that's demonstrating visual acuity gains across multiple visits.
We know from the natural history of the disease and literature that the average patient who goes untreated for wet AMD would actually lose a letter of vision per month. So, rather than losing three letters of vision, these patients have gained three, four, and five letters of vision. And this is also consistent with our NORSE-2 study where in the first three months, the two study arms were also dosed the same and demonstrated visual acuity gains at each visit. So, this gives us now two adequate well-controlled trials that are demonstrating a visual acuity improvement.
Jennifer, the company also announced for the first time the mean change in central retinal thickness data from NORSE-8. Can you put these data into context for investors?
I can. Thank you. So, central retinal thickness is an endpoint that is an anatomical measurement of the retinal thickness or the fluid in the back of the eye that is disturbing visual acuity. Physicians use this primarily as their means of determining how frequently a patient needs to be dosed with an anti-VEGF. And although the agency doesn't accept it as a primary endpoint, they certainly do look at it as additional evidence of activity of a product. So, in the NORSE-8 study, we reported that both study arms rapidly decreased the retinal thickness, which means they're reducing the fluid in the back of the eye, and that that reduction was not only maintained across the study but actually continued to improve at each visit. And the two study arms are not different.
So, again, this gives another layer of evidence to the totality of evidence that we will be presenting back to the FDA as the effect of ONS-5010 in these wet AMD patients.
Finally, Jennifer, the company has guided to refiling the BLA for ONS-5010 for Q1 calendar year of 2025. Can you provide any additional color on this timeline and the subsequent milestones in 2025 for the U.S. market?
I can. Thank you. Yes, we are excited about this data and to be able to present this back to the agency. So, we are targeting to refile our BLA before the end of this quarter. And then we'll set a clock with the FDA. So, the first thing that happens is the agency will provide us a letter within 30 days that acknowledges receipt of our filing. It will also provide us the confirmation of the classification, which this resubmission will be a Class 2, which means a six-month clock will be set for the review timeline. And that clock actually starts upon our filing, not upon the letter. So, six months from our filing, we will have then a review of the BLA.
That means that if we file here before the end of the Q1 , then before the end of the Q3 , we will have responses back from the agency.
This concludes the Virtual Investor, What This Means segment featuring Outlook Therapeutics. I'd like to extend a huge thank you to Dr. Jennifer Kissner for joining us today. And as a reminder, Outlook Therapeutics trades on Nasdaq under the ticker OTLK. And if you liked what you saw today, I encourage you to visit outlooktherapeutics.com for more information on the company and to sign up to follow the company to receive their alerts as well as follow their social channels to stay current on the latest information. You can also visit virtualinvestorco.com for a replay of today's event as well as our latest segments and event calendar. I want to thank everyone and wish you a great rest of your day.