Harrow Health announces IHEEZO FDA approval for ocular surface anesthesia
IHEEZO FDA approval : Harrow Health, a Nasdaq-listed eyecare pharmaceutical company, and Sintetica have secured approval for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% from the US Food and Drug Administration (FDA) approval for ocular surface anesthesia.
Sintetica, which is based in Switzerland, is focused on emergency and intensive care, analgesics, sterile injectable solutions, and local anesthetics.
IHEEZO is a sterile, single-patient‑use, ophthalmic gel preparation intended to be administrated by physicians.
Mark L. Baum — Harrow Health chairman and CEO, commenting on IHEEZO FDA approval, said: “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.
“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.”
IHEEZO’s safety and efficacy were shown in three human clinical trials.
Studies 1 and 2, which were randomized, double-blinded, placebo-controlled trials that assessed the effect of the ophthalmic gel preparation on healthy volunteers.
On the other hand, Study 3 was a randomized, prospective, active-controlled, observer‑masked trial that studied the administration of IHEEZO in patients having cataract surgery.
According to Harrow Health, Study 3 showed that IHEEZO worked quickly, nearly 1 to 1.5 minutes, and delivered enough anesthesia to successfully carry out the surgical procedure, lasting 22 minutes on average. The ophthalmic gel preparation also showed that none of the patients dosed with it needed a supplemental treatment to finish the surgical procedure.
Commenting on IHEEZO FDA approval, Nicola Caronzolo — Sintetica CEO said: “I am particularly proud of this important milestone, which exemplifies the quality of Sintetica’s research and development groups and our ability to innovate – to be a global pharmaceuticals leader.
“I want to give special thanks to our regulatory group, who while working with the Harrow Health team, performed extraordinarily well, resulting in this early U.S. market approval for this important new medicine.”