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.
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