The development pipeline
Merging global experience and technology to offer patients a brighter future
To promote our network-based drug discovery and global R&D efforts, Santen is placing significant emphasis on strengthening our relationships with universities, research organisations and other pharmaceutical firms to conceive new treatments for patients around the world. We hope such relationships will lead to the discovery and launch of novel therapies for severe dry eye disease, glaucoma, diabetic macular oedema and uveitis, a condition with limited treatment options.
Pipeline of prescription pharmaceuticals (clinical stage) As of July 2020
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An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Started an additional Phase 3 in December 2018 in the U.S. Filed for marketing approval in April 2015 in Asia.
A fixed dose combination drug of a prostaglandin F2α derivative and a beta-adrenergic receptor blocker. Launched in Japan in November 2014. Launched successively in European countries since January 2015. Launched successively in Asian countries since April 2016. Started Phase 3 in January 2019 in China.
• Ocular hypertension
An EP2 receptor agonist with a new mechanism of action. Started Phase 3 in September 2018 in the U.S. Launched in November 2018 in Japan. Received marketing approval in Korea in December 2019 with successive filings planned for Asian countries.
• Ocular hypertension
A prostaglandin analogue eye drop drug product with a novel mode of action that is a dual agonist for both FP and EP3 receptors for the treatment of glaucoma and ocular hypertension. Completed Phase 2b in the U.S. and Japan.
• Ocular hypertension
Muscarinic antagonist which reduces juvenile myopia progression. Started Phase 2/3 in August 2019 in Japan. Completed Phase 2 in April 2020 in Asia.
In August 2016, Santen acquired InnFocus, developer of PRESERFLO™ MicroShunt*, a drainage implant device designed to lower and sustain intraocular pressure (IOP) for the treatment of primary open-angle glaucoma through the drainage of aqueous humour. Completed pre-market approval rolling submission to the FDA in June 2020 in the U.S. Launched in Europe in January 2019. Filed successively for marketing approval in Asian countries following Korean filing in March 2020.
*PRESERFLO™ is the new trademark of Innfocus MicroShunt®. PRESERFLO™ MicroShunt will replace Innfocus MicroShunt® in the future.
An ophthalmic emulsion of a prostaglandin F2α derivative, for the treatment of glaucoma and ocular hypertension. Started Phase 3 in April 2019 in Europe and Asia.
• Ocular hypertension
A toric intraocular lens to treat aphakia after cataract surgery. Received manufacturing and marketing approval in Japan in November 2019.
Changes from Q4 FY19 (8 May 2020)
| Dev. code | Changes |
|---|---|
| DE-128 | Completed pre-market approval rolling submission to the FDA in June 2020 in the U.S. |
Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.
