Also, as I announced in my prepared comments, Reproxalap appears to be the only topically administered drug ever to demonstrate an improvement in chronic visual acuity, something that normally doesn’t happen as we age over 12 months. Therefore, I would think that there are many potential partners that are interested in Reproxalap. I can tell you that our partnering conversations are robust and, as I mentioned in my prepared comments, involved multiple parties across a wide array of terms. I do expect that partners would want to be involved with Reproxalap prior to label negotiations, which, in our case, I would expect to occur in the September to October timeframe. Regarding allergic conjunctivitis, we continue to see that indication as a major differentiator for any dry eye disease drug.
As you mentioned, there’s a considerable overlap between dry eye disease and allergic conjunctivitis. And it’s difficult for many healthcare providers to distinguish between those two diseases. Thus, a compound or drug that can treat both of them simultaneously should be of considerable value. Our main goal, at this point, Yigal, is to demonstrate the activity of Reproxalap in allergic conjunctivitis. We have two published papers, one of Phase 2 trial, one of Phase 3 trial, demonstrating activity of Reproxalap in patients with allergic conjunctivitis across two different clinical trial models. The INVIGORATE II trial, which is our second allergen chamber trial, will be announced, as I mentioned in my prepared comments this morning, in the first half of this year.
And I think pending the results of those trials, pending the partnership discussions with Reproxalap, that we can then make a decision about the — a need to submit a new drug application for Reproxalap in allergic conjunctivitis.
Yigal Nochomovitz: Great. Thank you.
Todd Brady: Thanks, Yigal.
Operator: Thank you. Our next question comes from Justin Kim from Oppenheimer & Co. Justin, please go ahead. Your line is open.
Justin Kim: Hi, good morning, Todd and team. Thanks for taking the questions and congrats on the progress. With Reproxalap and 2191 sort of locked in for regulatory review over the course of the year, I just wanted to ask how you think about commercialization for these assets, how they sort of may differ and how to think about the timeline for investment or commercialization as sort of a review process progresses?
Todd Brady: Good morning, Justin. Thanks for the question. As Bruce mentioned in his prepared comments, we are well capitalized for initial launches for both compounds. There are certain synergies, particularly in the back office, for launching both compounds. The sales efforts though are different. Reproxalap is obviously targeted towards optometrists and anterior segment ophthalmology. ADX-2191 is targeted towards retinal surgeons, particularly those that treat the rare retinal diseases that relate to 2191. I think that the breadth of sales activity and marketing activity regarding ADX-2191 is quite limited. And the reason I say that is because: A, retinal physicians are already using methotrexate to treat at least two of the diseases we’ve highlighted this morning; and B, there’s a limited number of physicians that treat these diseases.
I think there are something like 50 to 60 ocular oncologists in the United States. And therefore, I don’t really consider ADX-21 to be a sales and marketing effort per se, but rather more of a market access effort, making physicians aware that compounding methotrexate is no longer necessary and making physicians aware that ADX-2191 is in theory clinically superior to compounded methotrexate because the volume is lower, the volume for injection is lower, the density is higher, all of that designed to reduce the side effects that you typically see with methotrexate injection into the eye, which is something called punctate keratitis. As we announced last year as a result of the Phase 3 GUARD trial in proliferative vitreoretinopathy, the adverse events of keratitis was significantly lower than what one would expect with compounded methotrexate at least as has been published in the scientific literature.
