FDA approval of IHEEZO (chloroprocaine hydrochloride oOphthalmic gel) 3% for ocular surface anesthesia

IHEEZO is a sterile, single-patient use, physician administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.

IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

The safety and efficacy of IHEEZO were demonstrated in three human clinical studies. Studies 1 and 2 were randomized, double-blinded, placebo-controlled studies that evaluated the effect of IHEEZO on healthy volunteers, and Study 3 was a randomized, prospective, multi-center, active-controlled, observer?masked study that evaluated the administration of IHEEZO in patients undergoing cataract surgery.

Study 3 marks the first time a U.S. drug candidate was studied in a surgical model for FDA approval in the ocular surface anesthesia category. This study demonstrated that IHEEZO not only worked rapidly (about 1 to 1.5 minutes) and provided sufficient anesthesia to successfully perform the surgical procedure (on average lasting 22 minutes), but importantly, no patient dosed with IHEEZO required a supplemental treatment to complete the surgical procedure.