Unidentified Analyst: Hey, good morning. This is (ph) on for Tom. Just — thanks for taking our question. So, just two for us. So, for ADX-2191, could you provide additional color on how the recent priority review for ocular lymphoma may help other indications such as PVRL and retinitis pigmentosa? And for the second question, so for the visual acuity data, what will be the best strategy moving forward? Is this something you will try to include when you submit the safety data? Thanks.
Todd Brady: Hi, Sung. Good morning. Both of those are superb questions. Our regulatory strategy for ADX-2191 was quite intentional, and that is the idea is to get — submit an NDA for ocular lymphoma first. The reason is that methotrexate, which is the active ingredient of 2191, is standard of care for treatment of ocular lymphoma. It’s been injected in eyes for 30 years with acceptable safety and activity. After that, subsequent NDA submissions or so-called supplemental NDAs, where the bar is somewhat lower, because safety and the chemistry manufacturing controls aspects of ADX-2191 have already been evaluated in the original NDA submission. That’s why I highlighted this morning the safety results from the Phase 3 GUARD trial in proliferative vitreoretinopathy.
Those are particularly important for the lymphoma submission, because the FDA always assesses not only activity, but also safety. And in this case, we have a new formulation designed to be vitreous compatible with a lower volume and a higher density and so forth, and all that will be assessed from a safety standpoint as part of the lymphoma review. We were absolutely thrilled with the Phase 3 GUARD results in terms of safety. In terms of proliferative vitreoretinopathy, it appeared to be actually safer to administer methotrexate 2191 than it was not to administer 2191, which makes sense because methotrexate is a compound, is anti-inflammatory and may mitigate some of the trauma associated with surgery. But by and large, I think we have a compelling submission for lymphoma based not only on the safety, but also on the activity from the scientific literature.
The visual acuity data was quite remarkable and unexpected from the 12-month safety trial of Reproxalap. There is a 120-day update as part of a standard NDA review, which focuses on safety in particular. Obviously, the 12-month safety trial, the final data from the 12-month safety trial will be highlighted in that safety update, including the visual acuity data. What actually winds up in the label, I think, depends on negotiation with the FDA, but also we intend to publish the results of the safety trial. I think relative to other 12-month safety trials in dry disease, the visual acuity results are quite remarkable. And as I mentioned in my prepared comments, should stand to differentiate Reproxalap from our potential competition in the dry eye space.
Unidentified Analyst: Great. Thank you.
Todd Brady: Thanks, Sung.
Operator: Thank you. Our next question is from Catherine Novack from Jones Research. Catherine, please go ahead. Your line is open.
Catherine Novack: Hi, good morning. Thanks for taking my question. Just wanted to kind of extend on the last question. Can you — what was the change in visual acuity for the vehicle group in the safety study? And how clinically significant is this 37% improvement in in the treatment group?
