A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma

Part 1 will evaluate the safety and tolerability of single ascending doses of MGV354
compared to placebo in healthy male and female subjects. Part 2 will evaluate the safety and
tolerability of MGV354 in a multiple ascending dose design (two highest tolerated doses from
Part 1) compared to placebo when administered for 7 days to patients with ocular
hypertension or glaucoma. Part 3 will explore the safety, tolerability and efficacy of a
single dose level of MGV354 (maximum tolerated dose) compared to placebo when administered
for 7 days in patients with ocular hypertension or glaucoma.

Inclusion Criteria:

- Documented informed consent.

- Part 1: 18 to 70 years of age;

- Parts 2 and 3: 18 years of age or older;

- Able to communicate well with the investigator and understand and comply with the
requirements of the study;

- Body Mass Index (BMI) between 18 and 39;

- In case of contact lens wear, willing to remove lenses 30 minutes before the first
assessment until the end of the study. Corrective spectacles may be worn as needed.

- Sitting vital signs (systolic and diastolic blood pressure and pulse rate) within
normal ranges as specified in the protocol;

- Part 1 (Healthy Volunteers): In good health as determined by past medical history,
physical examination, vital signs, electrocardiogram, and laboratory tests at
screening.

- Parts 2 and 3 (Patients): Diagnosed with open-angle glaucoma or confirmed ocular
hypertension; mean IOP measurements in at least one eye after washout as specified in
the protocol

- Other protocol-specified inclusion criteria may apply.

Exclusion criteria:

- History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes;

- History of or current presence of clinically significant ECG abnormalities or
arrhythmias;

- History of malignancy of any organ system (other than localized basal cell carcinoma
of the skin or in-situ cervical or breast cancer), treated or untreated, within the
past 5 years;

- Known clinical history of heart failure, myocardial infarction, or stroke;

- Exposure during the four weeks preceding the Screening visit to any topical, inhaled,
or systemic corticosteroids;

- Angle grade less than Grade 2 in either eye;

- Any abnormality, including corneal thickness > 620 microns, preventing reliable
applanation tonometry;

- Pregnant or lactating women and women of child-bearing potential;

- Sexually active males must agree to use a condom during intercourse while taking drug
and for 6 days after stopping MGV354 medication and should not father a child in this
period;

- Positive HIV, Hepatitis B Ag or Hepatitis C Ab test result at Screening;

- Abnormal liver function tests;

- History or presence of impaired renal function;

- Part 1 (Healthy Volunteers): Use of any NEW prescription drugs or herbal supplements
within four (4) weeks prior to initial dosing, and/or NEW over-the-counter (OTC)
medication, dietary supplements (vitamins included) within two (2) weeks prior to
initial dosing.

- Parts 2 and 3 (Patients): Patients with specific disease condition(s) related to
open-angle glaucoma or ocular hypertension; patients who cannot safely discontinue
use of all topical ocular and/or systemic IOP-lowering medication according to
protocol-specified Washout Schedule; patients with ocular diseases or conditions as
specified in the protocol; patients taking certain medications as specified in the
protocol;

- Other protocol-specified exclusion criteria may apply.