IHEEZO

Phase III Data*

Rate of successful anesthesia without supplemental treatment

Measured equivalence of IHEEZO^® to tetracaine 0.5% solution
Primary endpoint: successful surface anesthesia
- Patient rating of 0 (no pain/discomfort) or 1 (occasional pressure sensation, less than 5 separate times during the procedure) at T4
- Without any supplemental treatment

Patients asked about ocular discomfort at 4 timepoints:

Just before
first incision

End of
capsulorhexis

End of
phacoemulsification

Just before intraocular
lens insertion

Successful anesthesia was achieved with 92.1% of patients in the IHEEZO arm and 90.5% in the tetracaine arm.

Defined as a patient rating of 0 or 1 just before intraocular lens insertion without any supplemental treatment.

Viscosity matters

Low-viscosity gel
for controlled,
even application^5,6

View safety data

Post-hoc analysis

A difference patients can feel—quickly²

Patients reported a lower pain score with IHEEZO¹

A post-hoc analysis of the Phase III study found that although the incidence of ocular surface anesthesia was comparable vs tetracaine, higher pain scores were more common in the tetracaine arm.¹

In the IHEEZO group, 12 patients reported a score of 2.

Phase III Data*

Rapid onset with comfort that goes the distance

Patients reported a lower pain score with IHEEZO¹

Average Procedure¹

10-15

minutes

10-15
minutes

Average Duration¹

21.5

minutes

21.5
minutes

*The Phase III clinical trial was a randomized, prospective, multicenter, active-controlled, observer-masked study in 338 patients undergoing routine cataract surgery.

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Important Safety Information

IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

IHEEZO should not be injected or intraocularly administered.

Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.

Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

Do not touch the dropper tip to any surface as this may contaminate the gel.

IHEEZO is indicated for administration under the direct supervision of a healthcare provider. IHEEZO is not intended for patient self-administration.

The most common adverse reactions in studies following IHEEZO administration (incidence greater than or equal to 5%) were mydriasis, conjunctival hyperemia, and eye irritation.

You are encouraged to report suspected adverse reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information about IHEEZO, please see the full Prescribing Information.