FDA approves chloroprocaine hydrochloride ophthalmic gel for ocular surface anesthesia

The U.S. Food and Drug Administration has approved Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.

This is the first approval 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.

“On behalf of all our ophthalmic physician partners and the patients they serve, we and our partners at Sintetica are grateful to the FDA for a New Drug Application (NDA) review process that resulted in the approval of IHEEZO in advance of our PDUFA target action date,” said Mark L. Baum, Harrow Chairman and Chief Executive Officer in a press release. “We have always believed in the unique clinical value of IHEEZO, and now that IHEEZO is approved for use in the U.S. market, it has the potential to become an indispensable premium tool for eyecare professionals and their patients requiring ocular surface anesthesia.”

Read the full press release here.