Additional Relevant Details Intraocular Pressure Reduction

■ ROCKET 2: Both AR-13324 0.02% q.d. (PM) and b.i.d. were non-inferior to timolol 0.5% b.i.d. for the primary efficacy population (BL IOP <25 mmHg). Numerically, b.i.d. dosing of AR-13324 provided a greater ocular hypotensive effect than q.d. dosing, but had a high rate of discontinuations due to AE’s (77/254, 30%).

 ■ ROCKET 1: AR-13324 0.02% q.d. (PM) did not meet the criteria for non-inferiority to timolol 0.5% b.i.d. in the primary efficacy population (BL IOP <27 mmHg). However, AR-13324 was non-inferior to timolol in a pre-specified secondary analysis of the PP subgroup with maximum BL IOPs of <25 mmHg

-An early benefit to pre-study PGA use is seen with AR-13324, but not with timolol. The lack of an early benefit for timolol indicates that the PGA IOP-lowering effect was effectively removed by the 4 week wash-out.

 ■ The pre-study PGA benefit for AR-13324 appears to diminish over time. In subjects not on PGA medication prior to the study, AR-13324 efficacy is stable over time (similar to timolol).

Safety Adverse Events

 ■ No drug-related SAEs were reported in any treatment groups

 ■ The most frequently reported adverse event for AR-13324 was conjunctival hyperemia

■ There was no evidence of treatment-related systemic effects (e.g. clinical laboratory or haematology values, heart rate or blood pressure) for AR-13324