Harrow and Sintetica Receives the US FDA’s Approval for Iheezo (chloroprocaine hydrochloride ophthalmic gel) to Treat Ocular Surface Anesthesia
Shots:
- The US FDA has approved Iheezo (3%) for ocular surface anesthesia. The approval was based on the 3 P-III studies i.e., (Study 1 & 2) evaluated Iheezo in a ratio of (4:1) & (2:1) in 145 healthy volunteers, and (Study 3) evaluated Iheezo in patients undergoing cataract
- In (Study 1 & 2), 90% vs 12% & 95% vs 20% achieved anesthesia at a median time was 0.67 in both studies; the median duration of anesthesia was 14.3 & 19.3min. In (Study 3), patients achieved anesthesia in 1 to 1.5min., and no patients required supplemental treatment to complete the surgical procedure lasted on avg. 22min.
- Iheezo is supplied as a package of 1 or 10 units of 1.25mL single-patient-use vial containing 24mg of chloroprocaine in 800mg of gel. The product will available in May 2023
Ref: PRNewswire | Image: Sintetica
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