1 reason one...it will be a success is this a p2 trial and its usually better controlled, patients tightly screened, we have a history of this drugs performance and it has a good safety profile
#2 they are not testing against a placebo but greater decrease of IOP in the combo drug vs single arms
#3 we don't have to rely on hope ....just consistency of the drug's lowering capability in previous p2 similar combo trial 2014 showed mean reductions see 10k filing;
After eight weeks of BID dosing in Part 1, patients treated with trabodenoson co- administered with latanoprost experienced further mean reductions of IOP of 3.4 and 4.9 mmHg from diurnal and study baselines, respectively, beyond the IOP-lowering of latanoprost. After switching to QD trabodenoson in Part 2, and treating for an additional four weeks, QD dosing with trabodenoson resulted in a mean reduction in IOP of 4.3 and 5.8 mmHg from diurnal and study baseline, respectively, from the IOP on latanoprost alone. At the end of Part 2 (after 12 weeks), the IOP-lowering seen in the Study Eye (the eye treated with trabodenoson) was statistically significantly greater than the IOP drop of the patient's Control Eye (the patient's other eye that only received QD latanoprost).
How often do you have a sneak peak of a p2 and results of p3 showing a drug is active.
I believe they might have just tested the 3% dose not 6% in the previous p2 combo trail but I need to check on that.
#4. the Phase 3 trial of trabodenoson was effective in lowering IOP, even though the trial failed. The Placebo was the issue. Combo trial is a different design vs monotherapy trial.
#5 I believe we are not reporting various data times as Endpoints such as 8am and 4pm times.
Just one "mean IOP change" from diurnal baseline for each dose arm of the trial.
#6 it's a p2 study it's not powered to show statistical significance ...so you don't have to worry about getting a p value of 0.055 and just miss out
The only CON I can think of is a 3 month study duration might have been better than 8weeks.
