Iheezo Drug Information

Generic name: CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL

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Uses of Iheezo

IHEEZO TM is indicated for ocular surface anesthesia.

Dosage & Administration of Iheezo

The recommended dose of IHEEZO TM is 3 drops applied topically to the ocular surface in the area of the planned procedure. IHEEZO TM may be reapplied as needed to maintain anesthetic effect.

Side Effects of Iheezo

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO TM or placebo.

The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1. Adverse Reactions in 5% or more of

IHEEZO TMPlacebo
Preferred TermN=151 n (%)N=50 n (%)
Mydriasis39 (26%)1 (2%)
Conjunctival hyperemia16 (11%)6 (12%)
Eye irritation9 (6%)2 (4%)
IHEEZO TMPlacebo
Preferred TermN=151 n (%)N=50 n (%)
Mydriasis39 (26%)1 (2%)
Conjunctival hyperemia16 (11%)6 (12%)
Eye irritation9 (6%)2 (4%)

Warnings & Cautions for Iheezo

Not for Injection or Intraocular Administration IHEEZO TM should not be injected or intraocularly administered.

Corneal Injury Due to Insensitivity 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.

Corneal Opacification

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

Risk of Contamination

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

For Administration by Healthcare Provider IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration.

Contraindications for Iheezo

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

Clinical Studies of Iheezo

Study 3 Study 3 (NCT04685538) was a randomized, prospective, multi-center, active-controlled, observer-masked study conducted to evaluate the efficacy and safety of IHEEZO TM (N=166) versus tetracaine ophthalmic solution 0.5% (N=172) in patients undergoing cataract surgery. The primary endpoint was defined as the proportion of patients in each treatment group gaining successful anesthesia without any supplementation. On average, patients needed 1-1.5 minutes to obtain sufficient anesthesia to successfully perform the surgical procedure which lasted on average 22 minutes.

No patient treated with IHEEZO TM required supplemental treatment to complete the intended surgical procedure.

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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