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 2021
Filter indication
An ophthalmic emulsion that improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue penetration. Launched successively in European countries since October 2018. Launched successively in Asian countries after receiving approval for an indication extension for Ikervis in August 2019. Launched in November 2019 in Canada. Received marketing approval in June 2021 in U.S. and filed for marketing approval in April 2021 in China.
A dry eye treatment which stimulates secretion of mucin and aqueous components from the corneal and conjunctival epithelium. Long-lasting drug. Completed Phase 3 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. Filed for marketing approval in November 2020 in the U.S. Launched in November 2018 in Japan. Filed successively for marketing approval in Asian countries and launched in February 2021 in Korea.
• 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
Non-selective 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. Filed for marketing approval in May 2021 in Japan. Launched in Europe in April 2019. Filed successively for marketing approval in Asian countries since March 2020. Received a rejection letter in Korea in April 2021; considering re-filing.
*PRESERFLO™ is the new trademark of Innfocus MicroShunt®. PRESERFLO™ MicroShunt will replace Innfocus MicroShunt® in the future. Offered product development, commercialisation and sales rights to Glaukos in Americas, Australia and New Zealand in May 2021. Completed premarket approval rolling submission in June 2020. Received feedback from the Food and Drug Administration (FDA) on its assessment at the end of February 2021. Discussions with the FDA are ongoing. Received marketing approval in March 2021 in Canada; preparing for a launch by Glaukos. Received marketing approval in May 2021 in Australia.
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
Selective muscarinic M2 antagonist which reduces juvenile myopia progression. Reduce mydriasis to selectively inhibit a subtype of receptors. Started Phase 1 in July 2021 in Japan.
A ROCK (Rho-associated kinase) inhibitor. Developed and sold by Aerie in the U.S. Started Phase 3 in November 2020 in Japan.
• Ocular hypertension
Changes from Q4 FY20 (11 May 2021)
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-076C/STN1007603 | Received marketing approval in June 2021 in U.S. |
| DE-128/STN2000100 | Received marketing approval in May 2021 in Japan. |
| STN1013400 | Started Phase 1 in July 2021 in Japan. |
