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 January 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. NDA filed 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 H1 receptor antagonist with membrane-stabilising function, as treatment for allergic conjunctivitis. High dose drug. Received manufacturing and marketing approval in September 2019 and launched in November 2019 in Japan.
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 December 2019 in Korea with successive filings in Asian countries.
• Ocular hypertension
A prostaglandin analogue eye drop drug product with a novel mode of action that acts on both FP and EP3 receptors (a dual agonist) 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. Started Phase 2 in November 2017 in Asia.
In August 2016, Santen acquired InnFocus, developer of PRESERFLO™ MicroShunt*, a drainage implant device designed to lower and stabilise intraocular pressure (IOP) for the treatment of primary open-angle glaucoma through the drainage of aqueous humour. Conducting Phase 2/3 in preparation for filing with the FDA in the U.S. Received CE Mark in Europe.
*PRESERFLO™ is the new trademark of Innfocus MicroShunt®. PRESERFLO™ MicroShunt will replace Innfocus MicroShunt® in the future.
An ophthalmic emulsion which improves vernal keratoconjunctivitis symptoms through immunosuppressive effect. Ocular tissue penetration enhanced by cationic emulsion technology. Received the Marketing Authorisation Application approval from European Commission Agency in July 2018 and launched in October 2018 in U.K. Received approval of expanded indication for Ikervis in August 2019 in Taiwan. Received marketing approval in December 2018 and launched in November 2019 in Canada.
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 for correcting astigmatism, which can be implanted into an aphakia eye after cataract surgery. Received manufacturing and marketing approval in November 2019 in Japan.
Changes from Q2 FY19 (6 November, 2019)
| Dev. code | Changes |
|---|---|
| DE-114A | Launched in November 2019 in Japan. |
| DE-117 | Received marketing approval in December 2019 in Korea. |
| DE-067C | Launched in November 2019 in Canada. |
| MD-16 | Received manufacturing and marketing approval in November 2019 in Japan. |
Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.
