Currently Enrolling Trials
Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% is an ester anesthetic.
Iheezo is specifically indicated for ocular surface anesthesia.
Iheezo is supplied as a topical gel for ophthalmic use. The recommended dose of Iheezo is 3 drops applied topically to the ocular surface in the area of the planned procedure. Iheezo may be reapplied as needed to maintain anesthetic effect.
Mechanism of Action
Chloroprocaine, like other local anesthetics, blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
The most common adverse reaction related to Iheezo is mydriasis.
Clinical Trial Results
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.