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 2022
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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. Filed for manufacturing and marketing approval in August 2021 in Japan.
An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Conducting an additional Phase 3 since December 2018 in the U.S. Filed for marketing approval in April 2015 in Asia.
An ophthalmic suspension which improves meibomian gland function via mTOR inhibition. Started Phase 2a in October 2021 in Japan. Planning to develop worldwide.
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. Conducting Phase 3 since January 2019 in China.
• Ocular hypertension
An EP2 receptor agonist with a new mechanism of action. Received a complete response letter from FDA in November 2021 and preparing for resubmission at the end of March 2022 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. Completed an additional Phase 2 in December 2021 in the U.S. Completed Phase 2b in Japan. Started Phase 2 (exploratory study) in September 2021 in Europe.
• Ocular hypertension
Non-selective muscarinic antagonist which reduces juvenile myopia progression. Conducting Phase 2/3 since August 2019 in Japan. Started Phase 1 since September 2021 in China. Completed P2 in April 2020 in Asia.
Non-selective muscarinic antagonist, which reduces juvenile myopia progression. Sydnexis Inc., the licensor, is conducting Phase 3 trial in Europe and the U.S. Santen has obtained the licence for Europe, Middle East and Africa.
In August 2016, Santen acquired InnFocus, developer of 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 and received approval in Singapore and other countries since September 2021. Received rejection letter in April 2021 but considering re-filing in Korea.
Licence-out to Glaukos in Americas, Australia and New Zealand in May 2021. Completed premarket approval rolling submission to the FDA in June 2020. Received FDA's notification on assessment in the end of February 2021; continuing negotiations in the U.S. Received marketing approval in March 2021 in Canada and in May 2021 in Australia.
An ophthalmic emulsion of a prostaglandin F2α derivative for the treatment of glaucoma and ocular hypertension. Conducting Phase 3 trials since 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 September 2021 in Japan.
A ROCK (Rho-associated kinase) inhibitor. Developed and sold by Aerie in the U.S. Conducting Phase 3 since November 2020 in Japan. Planning to file for marketing approval in fiscal 2021 in Asia and considering development plans for Europe and China. Planning launch and development of a combination drug including STN1013900 worldwide.
• Ocular hypertension
Changes from Q2 FY21 (8 November 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 |
|---|---|
| STN1011700 / DE-117 | Received a complete response letter from FDA in November 2021 and preparing for resubmission at the end of March 2022 in the U.S. |
