The US Food and Drug Administration (FDA) has approved IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia by applying it topically to the area. The safety and efficacy of IHEEZO were demonstrated in three human clinical studies.
The first two studies were randomized, placebo-controlled, and double-blinded and evaluated the effect of IHEEZO on healthy volunteers, and the third study was a randomized, multi-center, prospective, and active-controlled study that evaluated the administration of IHEEZO in patients undergoing cataract surgery.
Mark L. Baum, CEO and chairman of Harrow, said that on behalf of all their ophthalmic physician partners, they are grateful to the US FDA for a New Drug Application (NDA) review process that has resulted in the approval of IHEEZO in advance of their PDUFA target action date.
Mark L. Baum added that, they have always believed in the unique clinical value of IHEEZO, and it has the potential to become an indispensable premium tool for eyecare professionals, and their patients who require ocular surface anesthesia.
Nicola Caronzolo, CEO of Sintetica, added that they are proud of this important milestone that exemplifies the quality of the research and development groups of Sintetica, and their ability to innovate for being a global leader in pharmaceutical industry.