For the second time in 15 months, Japanese ophthalmology specialist Santen has earned an FDA approval for its eye drops.
The U.S. regulator has signed off on Santen’s Omlonti to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Santen developed the drug, otherwise known as omidenepag isopropyl ophthalmic solution, along with another century-old Japanese firm, UBE Industries of Tokyo.
The green light comes after Santen scored a nod in June of 2021 for Verkazia eye drops to treat vernal keratoconjunctivitis (VKC), an allergic condition that causes inflammation and most often strikes children.
As a selective prostaglandin EP2 receptor agonist, Omlonti provides patients with primary open-angle glaucoma or ocular hypertension—both of which can cause blindness—a treatment with a unique mechanism of action, Santen said.
“This approval is an important milestone in our ambition to tackle unmet needs in eye health,” Peter Sallstig, the chief medical officer of Santen, said in a release.
Known as Eybelis in Japan, the drops won approval there in 2018. On top of that, five more countries in Asia sanctioned the treatment last year. It is Santen’s first glaucoma offering in the U.S. Approximately 3 million people in the U.S. and 76 million worldwide have the two conditions, with numbers increasing as the global population ages, Santen said.
Omlonti won its FDA nod based on the results of three trials, all conducted over three months, with one study extended by an additional nine months. Patients in the studies showed consistent improvement in intraocular pressure (IOP), a key measure in both conditions.
Osaka-based Santen has been an active wheeler-dealer in its efforts to increase its presence in ophthalmology. In 2020, Santen partnered with Alphabet subsidiary Verily to apply “microelectronics and scalable digital technologies” in building “unique ophthalmic devices.”
In 2016, Santen shelled out $225 million to acquire InnFocus, the maker of the MicroShunt, which is designed to treat patients in the mild to severe stage of glaucoma. Two years earlier, Santen paid $600 million to acquire the marketing rights to eight Merck eye drugs in several geographies. In 2011, Santen bought up French biotech Novagali Pharma and its ophthalmology pipeline in a deal worth about $139 million.