FDA approves Iheezo for ocular surface anesthesia
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The FDA has approved Iheezo ophthalmic gel for ocular surface anesthesia, according to a joint press release from Harrow and Sintetica.
Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% is the first branded ocular anesthetic approved for the U.S. ophthalmic market in almost 14 years, according to the release. Its safety and efficacy were supported by three studies, the first two investigating Iheezo’s effects in healthy volunteers and the third in participants undergoing cataract surgery.
The third study was the first time a U.S. drug candidate was studied in a surgical model for FDA approval in the ocular surface anesthesia category, according to the release. Iheezo began working within 1 to 1.5 minutes and provided enough anesthesia to successfully perform the surgical procedure, which lasted 22 minutes on average. No participant dosed with Iheezo required a supplemental treatment to finish the procedure.
Iheezo will be commercially launched in 2023.
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