Iheezo Drug Information
Generic name: CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL
Uses of Iheezo
is indicated for ocular surface anesthesia. IHEEZO TM is an ester anesthetic 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. 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. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+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 TM Treated Patients in Studies 1 and 2 IHEEZO TM Placebo Preferred Term N=151 n (%) N=50 n (%) Mydriasis 39 (26%) 1 (2%) Conjunctival hyperemia 16 (11%) 6 (12%) Eye irritation 9 (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
is contraindicated in patients with a history of hypersensitivity to any component of this preparation. IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation.
Clinical Studies of Iheezo
Study 1 and 2 Study 1 (NCT04779606) and Study 2 (NCT04753710) were
randomized, double-blinded placebo-controlled studies conducted to evaluate the efficacy, safety, and local tolerability of IHEEZO TM in 145 healthy volunteers. In Study 1, 85 healthy male and female were randomized in a 4:1 ratio to receive a single ocular instillation of IHEEZO TM (N=68) or placebo (N=17). The double blinded treatment included a IHEEZO TM or a placebo dose of 3 drops instilled at 1 minute ± 15 seconds intervals in the right eye of each volunteer. The median age was 39 years (range 19 to 55 years); 59% female and 41% male.
In Study 2, 60 healthy male and female were randomized (40:20) to receive single or multiple ocular instillations of IHEEZO TM dose of 3 drops in the right eye. The median age was 25 years (range 18 to 59 years); 54% female ad 46% male. The efficacy in Study 1 and 2 was determined by proportion of patients achieving full conjunctival anesthesia evaluated by conjunctival pinching, 5 minutes after administration.
Efficacy results of Study 1 The proportion of subjects with successful anesthesia was 90% in IHEEZO TM group and 12% in the placebo group (p<0.01). The median time for the IHEEZO TM group achieving anesthesia was 0.67 minutes. The median duration of anesthesia was 14.3 minutes. Efficacy results of Study 2 The proportion of subjects with successful anesthesia was 95% in the IHEEZO TM group and 20% in the placebo group (p<0.01). The median time for the IHEEZO TM group achieving anesthesia was 0.67 minutes.
The median duration of anesthesia was 19.3 minutes.
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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