FDA Approves First Branded Ocular Anesthetic In Almost 14 Years

The FDA approved Harrow Health Inc HROW and Sintetica S.A's Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.
Iheezo is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation containing no preservatives.
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. 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 perform the surgical procedure successfully (on average lasting 22 minutes), but no patient dosed with Iheezo required a supplemental treatment to complete the surgical procedure.
The company has accelerated its market access strategy to support a commercial launch date slightly ahead of its planned launch at the May 2023 American Society of Cataract and Refractive Surgery meeting.
Price Action: HROW shares closed higher by 27.86% at $9.73 on Tuesday.