FDA to review Kowa Pharmaceuticals’ NDA for glaucoma eye drop K-911

The US FDA is set to review Kowa Pharmaceuticals America’s NDA for K-911, an investigational once-daily eye drop aimed at IOP in OAG or OHT patients. The NDA is supported by two pivotal Phase III trials comparing K-911 0.1% with latanoprost 0.005%. K-911 is being developed as a topical ophthalmic monotherapy formulated as a sterile solution. Credit: Gorodenkoff / Shutterstock.com. The US Food and Drug Administration (FDA) is set to review Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop aimed at reducing intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients.…

Source: Pharmaceutical Technology