IHEEZO

14.1 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% f...

Most common adverse reaction is mydriasis (approximately 25%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 844.446.6979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 descr...

IHEEZO TM 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. ( 4 )

Not for Injection or Intraocular Administration ( 5.1 ). Corneal Injury Due to Insensitivity ( 5.2 ). Corneal Opacification ( 5.3 ) For Administration by Healthcare Provider : IHEEZO TM is not intended for patient self-administration ( 5.5 ). 5.1 Not for Injection or Intraocular Administration IHEEZO TM should not be injected or intraocularly administered. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental ...