A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study

This is a Phase III, randomized, double-masked, active-controlled, parallel-group,
multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at
Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any.
After completing the required washout period, subjects will return for Visit 2 (Baseline, Day
1). Subjects who meet all eligibility criteria at baseline will be randomized to receive
double-masked treatment for 3 months. Adult subjects will receive open-label DE-117
Ophthalmic Solution for an additional 9 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who
meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

- DE-117 Ophthalmic Solution once daily and Vehicle once daily, or

- Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the
efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate
Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will
provide additional safety data through Month 12 for subjects receiving DE-117.