Question-and-Answer Session
Operator
Thank you, sir. (Operator's Instructions) Our first question today comes from John Gibbons of Odeon Partners.
John Gibbons - Odeon Partners
Hi, gentlemen. Nice support — thank you for all the updates. Bob, can you just explain to me or remind me again the difference between the RADICAL study and the DENALI study for the Visudyne?
Robert L. Butchofsky
Yeah, John. Thanks. The RADICAL study really looked at a couple of different questions. There were four treatment arms, and the broad question from the combination study was whether or not using Visudyne in combination with Lucentis and potentially a steroid gives you similar vision outcomes as compared to Lucentis monotherapy and if it gives you that, what is the impact on using combination therapy on the number of treatments required over the course of 12 or 24 months?
So the RADICAL study looked at whether or not there's a benefit of adding a steroid to that regimen and cutting to the chase, what we found is that the triple therapy regiment of Visudyne and Lucentis and the steroid was the best outcome. There wasn't a statistically significant difference between treatment arms, but it gave the best visual acuity of the combination arms and that was slightly better — again, not statistically significantly better than Lucentis monotherapy, but it was in line certainly with all the data that's been generated with Lucentis so we showed about a line and a half of visual acuity improvement.
Importantly, we showed a statistically significant reduction in the number of treatments required through 12 months. In the combination arm we had almost half the number of treatments required through 12 months. So that's probably what the result is from RADICAL. We'll report the 24 month data as I’ve said, in the first half of next year.
The DENALI study looks at a similar regimen, but it's using half fluence Visudyne in combination with Lucentis without a steroid just compared to Lucentis monotherapy. So a slightly different question will be answered by the DENALI study and we expect that data to come out, as I've mentioned, early next year.
John Gibbons - Odeon Partners
And would you hope to get the same number on the number of injections?
Robert L. Butchofsky
Yeah. The hope would still be the same, but as we showed in RADICAL, there seemed to be a benefit by the addition of the steroid. It prolonged the treatment benefit and led to the greatest decrease in treatment frequency. So we do think that there's probably a benefit to adding the steroid and that was one of the benefits of the RADICAL study design.
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