- Micro-cap eyecare pharmaceutical company Harrow Health ( NASDAQ: HROW ) and Swiss injectable medicines firm Sintetica on Tuesday said the U.S. FDA had approved their gel for anesthesia of the surface of the eye.
- Shares of HROW jumped 27.3% to $9.69 in afternoon trading.
- The gel, Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3%, is a single patient?use, physician?administered preparation that contains no preservatives.
- The companies said the gel was 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, HROW and Sintetica said in a statement .
- The approval of the gel was based on three human clinical studies that demonstrated its safety and efficacy.
- "Harrow currently provides perioperative medications for a significant number of the U.S. ophthalmic surgical procedures," HROW CEO Mark Baum said, adding that the company had a customer base of more than 10K ophthalmologists, optometrists, retina specialists, outpatient hospital facilities, and ambulatory surgery centers.
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Harrow Health soars ~27% on FDA nod of anesthesia gel for the surface of the eye