- Touting positive topline results from the second of two Phase 3 studies, Santen Pharmaceuticals on Monday said it would submit its treatment for uveitis to the Food and Drug Administration for approval in early 2017.
- Uveitis is a broad class of inflammatory illnesses which are quite harmful to eye tissues. In fact, research suggests uveitis is responsible for 10% of all blindness cases in the U.S.
- Santen's drug Opsiria (sirolimus) aims to cure forms of the disease that attack the back side of the eye — where the retina is located, for example — and that are not caused by bacteria or viruses.
Santen lives by its ophthalmology offerings. In the first half of the Japanese company's fiscal year, which ended Sept. 30, prescription eye drugs brought in ¥89.3 billion ($797 million) in sales, more than 90% of its total revenues.
As such, the company has been busy pushing more candidates through trials and to market. This year alone, Santen saw the approval of DE-111, a fixed-dose combo of tafluprost and timolol maleate for the treatment of glaucoma and ocular hypertension, as well as the launches of four other eye care drugs in markets throughout Asia, according to its most recent quarterly financial report.
What's more, Santen acquired ophthalmology devices manufacturer InnFocus Inc. this summer for $225 million upfront, plus potential milestone payments. The deal gives the drugmaker access to the target's MicroShunt implant used to alleviate eye fluid pressure in patients with glaucoma. The device is currently in Phase 3 testing in the U.S. and has been approved in Europe.
Opsiria, meanwhile, had previously received orphan drug designation from the the FDA and European Commission. In both Phase 3 trials it was put through, the drug cleared up vision and met safety goals, though the most recent study showed dosing (44 micrograms versus 440 micrograms) had little impact on the drug's effectiveness.
“Opsiria will address a significant need in the management of non-infectious uveitis of the posterior segment as a locally-delivered option for this orphan disease," Santen's Chief Scientific Officer Naveed Shams said in a Nov. 28 statement.