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 2021
Filter indication
A dry eye treatment which stimulates secretion of mucin and aqueous components from the corneal and conjunctival epithelium. Long-lasting drug. Started Phase 3 in March 2020 in Japan.
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 successively 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. Started an additional Phase 2 in December 2020 in the U.S. Phase 2b completed in 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 April 2019. Filed successively for marketing approval in Asian countries following Korean filing in March 2020. Filed for marketing approval in October 2020 in Canada.
*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 ROCK (Rho-associated kinase) inhibitor. Aerie has developed and sales in the U.S. Started Phase 3 in November 2020 in Japan.
• Ocular hypertension
A toric intraocular lens to treat aphakia after cataract surgery. Launched in November 2020 in Japan.
Changes from Q2 FY20 (6 November 2020)
Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.
| Dev. code | Changes |
|---|---|
| DE-117/STN1011700 | Filed for marketing approval in November 2020 in the U.S. |
| DE-126/STN1012600 | Started an additional Phase 2 in December 2020 in the U.S. |
| DE-128/STN2000100 | Filed for marketing approval in October 2020 in Canada. |
| AR-13324/STN1013900 | Started Phase 3 in November 2020 in Japan. |
| MD-16 | Launched in November 2020 in Japan. |
