Health Canada has approved Apotex’s IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel 3%), a preservative-free topical anesthetic for ocular surface anesthesia in adults, expanding the company’s ophthalmology portfolio.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Canadian pharmaceutical company Apotex Inc. has received Health Canada approval for IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel 3%), a topical ophthalmic anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures in adults.
IHEEZO will be supplied as a sterile, preservative-free gel in single-use vials for administration by qualified eye care professionals. The product is not intended for patient self-administration and is not indicated for pediatric use.
The approval expands Apotex’s ophthalmology portfolio, which includes Verkazia®, Clobivis™, and Aflivu, the company’s aflibercept biosimilar. With IHEEZO, Apotex extends its presence across ocular inflammation, retinal disease, and procedural eye care.
Ophthalmic Anesthesia in Eye Procedures
IHEEZO contains chloroprocaine hydrochloride, a local anesthetic that temporarily blocks nerve signal transmission on the ocular surface. Topical anesthetics are routinely used during procedures such as cataract surgery, intravitreal injections, laser treatments, and diagnostic interventions to reduce discomfort and support procedural precision. The preservative-free gel formulation may help minimize ocular surface exposure to preservatives, while single-use vials support sterility and controlled administration.
Regulatory and Clinical Positioning
Health Canada’s approval confirms that regulatory authorities reviewed IHEEZO’s efficacy, safety, manufacturing quality, and administration profile. No new clinical trial data were disclosed with the announcement. Healthcare professionals are advised to consult the full Product Monograph for detailed prescribing information, including dosing guidance, warnings, precautions, and adverse reactions.
Martin Arès, President of Apotex Canada and Rest of World, said the approval reflects the company’s continued focus on supporting Canadian clinicians with reliable ophthalmic therapies while expanding its ocular care portfolio.
Commercial Outlook
Apotex expects IHEEZO to become available to healthcare professionals across Canada following regulatory clearance. The launch adds another specialty ophthalmic product to the company’s commercial portfolio, aligning with growing demand for outpatient ophthalmic procedures driven by aging populations and increasing retinal disease prevalence.
Reference
Apotex expands ophthalmic portfolio with Health Canada approval of IHEEZO™
About the Writer
Mahathi Palivela (LinkedIn) is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication.