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 April 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 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 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. Conducting Phase 2/3 in the U.S. in advance of application to FDA. Launched in Europe in January 2019. In Asia, filed for marketing approval in March 2020 in Korea.
*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. Cationic emulsion technology has enhanced ocular tissue penetration. Received the Marketing Authorisation Application approval from European Commission Agency in July 2018 and was launched successively in European countries starting with the U.K. in October 2018. Received approval for an indication extension for Ikervis for VKC in Asian countries starting with Taiwan in August 2019. 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 to treat aphakia after cataract surgery. Received manufacturing and marketing approval in November 2019 in Japan.
Changes from Q3 FY19 (4 February 2020)
| Dev. code | Changes |
|---|---|
| DE-122 | Expected efficacy was not demonstrated in P2a; development discontinued in March 2020. |
| DE-128 | In Asia, filed for marketing approval in March 2020 in Korea. |
Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.
