Introduction
Ripasudil, a rho-kinase (ROCK) inhibitor, has been a significant player in the treatment of glaucoma and ocular hypertension. Developed by D. Western Therapeutics Institute (DWTI), this drug has shown promising results in enhancing the conventional outflow of aqueous humor, thereby reducing intraocular pressure (IOP).
Development History
Ripasudil was first approved in Japan in September 2014 for the treatment of ocular hypertension and glaucoma under the brand name GLANATEC® ophthalmic solution 0.4%[4].
- Global Expansion: Since its initial approval, ripasudil has been approved for commercial use in the United Kingdom and has seen launches in other countries such as Thailand, Singapore, and Malaysia[2].
Current Development Status
Clinical Trials and Approvals
- Combination Therapy: A fixed combination drug containing ripasudil hydrochloride hydrate and brimonidine tartrate, known as GLA-ALPHA®, has been launched in Japan. This combination drug has three mechanisms of action, making it a robust treatment option for glaucoma and ocular hypertension[2].
- Phase III Clinical Trials: Phase III clinical trials for the combination drug (GLA-ALPHA®) began in Japan, and the drug has been performing well, with sales projected to peak at JPY8.1 billion in Japan[2].
Ongoing and Future Plans
- Global Phase III Trials: Global Phase III clinical trials for ripasudil in the context of Fuchs endothelial corneal dystrophy (FECD) commenced in March 2023. These trials are ongoing in the U.S., Europe, and other regions[2][5].
- Regulatory Milestones: The drug patent for the single-agent ripasudil is set to expire in September 2024, but DWTI expects to receive royalties for up to two years after the data protection period ends[2].
Market Projections
Revenue and Sales
- Current Sales: Sales of GLANATEC® and GLA-ALPHA® have been steadily increasing. In Japan, sales of GLA-ALPHA® are projected to peak at JPY8.1 billion, with approximately 230,000 patients expected to be treated over ten years following the launch[2].
- Royalty Income: DWTI anticipates continued royalty income from the single-agent and combination drugs. Although the single-agent sales are nearing their peak, royalties from the combination drug are expected to grow[2].
Market Growth
- Glaucoma Market: The global glaucoma treatment market is expected to grow, driven by the introduction of new products and an increase in glaucoma prevalence due to an aging population. The U.S. is expected to remain the dominant market, with sales projected to increase from $1.7 billion in 2013 to $2.2 billion by 2023[3].
- FECD Market: The market for Fuchs endothelial corneal dystrophy, where ripasudil is also being developed, is expected to grow significantly. The market size in the seven major markets (7MM) reached $858 million in 2023 and is projected to grow further by 2034[5].
Competitive Landscape
- ROCK Inhibitors: Ripasudil is part of a class of ROCK inhibitors that include other drugs like netarsudil and fasudil. These inhibitors are gaining traction for their effectiveness in treating glaucoma and other ocular conditions[4].
- Combination Therapies: The combination of ripasudil with other agents, such as brimonidine tartrate, places it competitively in the market against other fixed-dose combination products like tafluprost and timolol, and brimonidine and brinzolamide[3].
Key Takeaways
- Effective Treatment: Ripasudil has proven to be an effective treatment for glaucoma and ocular hypertension by enhancing the conventional outflow of aqueous humor.
- Global Expansion: The drug has been approved and launched in several countries, with ongoing global Phase III trials for FECD.
- Market Growth: The market for glaucoma and FECD treatments is expected to grow, driven by new product introductions and an aging population.
- Royalty Income: DWTI anticipates continued royalty income from both single-agent and combination drug sales.
FAQs
What is Ripasudil used for?
Ripasudil is used for the treatment of glaucoma and ocular hypertension. It works by enhancing the conventional outflow of aqueous humor, thereby reducing intraocular pressure (IOP).
Where is Ripasudil approved?
Ripasudil is approved in Japan, the United Kingdom, and has been launched in several other countries including Thailand, Singapore, and Malaysia.
What is the current development status of Ripasudil for Fuchs Endothelial Corneal Dystrophy (FECD)?
Global Phase III clinical trials for ripasudil in the treatment of FECD commenced in March 2023 and are ongoing in the U.S., Europe, and other regions.
How does Ripasudil compare to other glaucoma treatments?
Ripasudil is part of a class of ROCK inhibitors and is competitive against other fixed-dose combination products due to its three mechanisms of action when combined with brimonidine tartrate.
What are the market projections for Ripasudil?
Sales of GLANATEC® and GLA-ALPHA® are projected to continue growing, with significant revenue expected from royalties. The global glaucoma and FECD markets are also expected to grow, driven by new product introductions and an aging population.
Sources
- D. Western Therapeutics Institute (DWTI) | 4576 - [PDF]
- Q2 FY12/23 Financial Results Briefing Materials - [PDF]
- Glaucoma Treatment Market Value Projected to Hit $3 Billion by 2023 - [PDF]
- ROCK Inhibitors in Corneal Diseases and Glaucoma—A Comprehensive Review - MDPI
- Fuchs Endothelial Corneal Dystrophy Market to Exhibit Promising Growth During the Study Period 2020-2034 - GlobeNewswire