US Ophthalmic Pipeline and Clinical Trials
Santen is committed to developing new therapies, devices, and other solutions to serve significant unmet needs in ophthalmology and to fuel hope for physicians and patients facing the possibility of vision impairment or loss.
Our US headquarters is an important part of Santen’s global R&D development effort, allowing us to ensure the highest quality standards and an efficient process for developing differentiated ophthalmology solutions.
The following is a summary of therapies currently in development in the United States.
DRY EYE & CORNEAL DISORDERS
More About Our Investigational Therapies and Devices
A minimally invasive glaucoma surgery device intended for reduction of intraocular pressure (IOP) in eyes of patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. The MicroShunt (DE-128) received a CE mark in January 2012 and was added to the Santen pipeline via acquisition of InnFocus, Inc.
See Clinical Trial >
Omidenepag isopropyl (DE-117)
A topical ophthalmic solution in clinical development for the treatment of elevated intraocular pressure in patients with glaucoma or ocular hypertension. The active metabolite, omidenepag, has a different, novel mechanism of action compared to other currently available medications. It is a selective agonist for the prostanoid receptor, EP2, in contrast to the prostaglanding analogs (PGAs), a commonly prescribed class of medications that acts on a FP receptor. Omidenepag isopropyl increases the pathway of aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways, while PGAs are thought to increase the uveoscleral outflow pathway only.
SPECTRUM PROGRAM >
A prostaglandin eye drop product with a novel mode of action that is both an FP- and EP- receptor dual agonist being developed for the treatment of ocular hypertension and glaucoma. In-licensed from Ono Pharmaceuticals, Inc.
See Clinical Trial >
- IVT Sirolimus (DE-109)
An mTOR inhibitor and first-in-class immunoregulator that is being developed for resolving intraocular inflammation in non-infectious uveitis of the posterior segment (intermediate, posterior, and panuveitis). The Phase 3 LUMINA trial is currently underway to assess the efficacy and safety of IVT sirolimus given every 2 months compared with a sham control in adult patients with this disease.
SEE LUMINA TRIAL >
Dry Eye & Corneal Disorders
A topical ophthalmic emulsion with a unique technology to enhance ocular tissue absorption to improve signs and symptoms of vernal keratoconjunctivitis via immunosuppressive effect. A global Phase 3 trial, including US sites, is complete.