28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension

The total study duration for one patient is up to 11 weeks, including a screening period of
up to 6 weeks run-in (depending on washout requirements), a 4-week treatment period, and a
1-week follow-up period.

The study design is also a parallel cohort study to assess the safety, tolerability, and
pharmacodynamic activity of SAR366234.

Inclusion criteria:

- Male or female patients ≥18 years of age.

- Patients diagnosed with OAG (including pseudoexfoliation and pigment dispersion
syndromes and patients with a history of narrow angle closure with a patent
peripheral iridotomy) or OHT.

- Documented intraocular pressure (IOP) fulfilling the eligibility criteria (below) at
both the screening and baseline visits:

- At the screening visit

- an IOP ≤21 mmHg in both eyes if currently treated with an IOP-lowering medication or

- an IOP ≥22 mmHg and <36 mmHg if treatment-naïve or not on IOP lowering medication for
at least 5 weeks.

- At the baseline visit following washout

- an IOP ≥22 mmHg and <36 mmHg at about 8:00 am,

- an IOP >20 mmHg and <36 mmHg at about 12:00 noon, and

- an IOP >18 mmHg and <36 mmHg at about 4:00 pm.

- Baseline laboratory parameters within the defined screening threshold for the
Investigator site, unless the Investigator considers and documents an abnormality to
be clinically irrelevant.

- Having given written informed consent prior to undertaking any study-related
procedure, including stopping their current glaucoma treatment, if any, and engaging
into the corresponding washout procedures.

- Patients should agree to discontinue any concomitant topical ocular medication(s) and
current IOP-reducing agents.

- Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score
of +1.0 logMAR (Snellen equivalent 20/200) or better in both eyes at the screening
and baseline visits.

- Patients on systemic β blockers must be on a stable dose for at least 2 weeks before
screening and should expect to continue the treatment during the study with no
anticipated alteration in the medication dose.

- Patients should agree to discontinue contact lenses during treatment with the study
medication.

Exclusion criteria:

- Any clinically significant disease or concomitant medication that would interfere
with the study evaluation.

- Patients with advanced glaucoma at risk of progression during the study in the
opinion of the Investigator.

- Presence or history of hypersensitivity to latanoprost or known history of
non-response to any prostaglandin analog given for the reduction of IOP.

- History of hypersensitivity or allergy to any component of the investigational
medicinal product or any of the diagnostic medications or materials used in the
conduct of the study.

- Use or expected need for ocular (topical, periocular, or intravitreal), local
(inhaled or nasal), or systemic glucocorticoid medications within 4 weeks prior to
the baseline visit and for the duration of the study.

- Any vaccination within the last 28 days from randomization or during screening
whichever is longer.

- Any patient in the exclusion period of a previous study according to applicable
regulations.

- Any patient who cannot be contacted in case of emergency.

- Any patient who is the Investigator or any subinvestigator, research assistant,
pharmacist, study coordinator, or other staff thereof, directly involved in
conducting the study.

- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen,
anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and
2 antibodies (anti-HIV1 and anti HIV2 Ab).

- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, opiates) unless the result of a medical
prescription.

- An IOP ≥36 mmHg at any time during the screening, baseline, or randomization visits
(Day 1 predose).

- History of ocular surgery (including laser) or trauma in either eye within 6 months
of the screening visit.

- History of glaucoma filtering surgery or aqueous shunt procedures (traditional valves
and/or microinvasive glaucoma surgery [MIGs]).

- History of ocular infection within the past 3 months or ongoing or recurrent ocular
inflammation (ie, moderate to severe blepharitis, allergic conjunctivitis, herpetic
keratitis, peripheral ulcerative keratitis, scleritis, or uveitis) in either eye. Any
ocular abnormalities or symptoms indicative of ongoing ophthalmic disease (except if
related to glaucoma or OHT).

- Central corneal thickness <500 µm or >620 µm at the baseline visit.

- Any evidence of cornea guttata or corneal endothelial dysfunction from medical
history or at the baseline visit.

- Uncontrolled disease that would interfere with the study conduct, the interpretation
of the study results, or the ability of the patient to meet the requirements of the
study schedule.

- Any corneal abnormalities preventing reliable applanation tonometry.

- Closed/barely open anterior chamber angle or a history of acute angle closure in
either eye not adequately treated with a peripheral iridectomy.

- Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic
retinopathy, advanced age-related macular degeneration, inherited retinal
dystrophies) in either eye.

- Advanced optic nerve abnormality or history of visual field loss in either eye based
on the assessment of the Investigator which could put the patient at risk of glaucoma
progression by participating in the study.

- History of aphakia, pseudophakia with a torn posterior lens capsule, macular edema,
or known risk factors for macular edema in either eye.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.