CHAMP: Study of NVK-002 in Children With Myopia

This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study
conducted in 2 stages.

Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be
allocated to 1 of 3 study medications.

Stage 2 is a randomized cross-over phase of 1 year in duration, during which subjects will be
re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to
Vehicle only eligible for randomization to low or high-dose NVK-002.

Treatment arms are:

- NVK-002 low dose concentration

- NVK-002 high dose concentration

- Vehicle (placebo)

Inclusion Criteria:

1. Children aged 3 to ≤ 17.0 years.

2. Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each eye as
measured by cycloplegic autorefraction.

Exclusion Criteria:

1. If present, astigmatism more than -1.50 D in either eye.

2. Current or history of amblyopia or strabismus.

3. History of any disease or syndrome that predisposes the subject to severe myopia
(e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).

4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus,
lenticonus, spherophakia).

5. Serious systemic illness that, in the Investigator's opinion, would render the subject
ineligible.

6. Chronic use (more than 3 days per week) of any topical ophthalmic medications
(prescribed or over the-counter) other than the assigned study medication.