A New Long-Term Treatment Option for nAMD and DME Patients
Chugai Pharmaceutical has reported results from its Japan-based Phase I/II TEIEN study for the Port Delivery System with Ranibizumab (PDS). Early findings show stable efficacy and a safety profile consistent with global studies.
Why This Matters?
Treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) is demanding. Patients often need injections every 4–16 weeks. Consistency is tough. The burden is heavy for families and clinics.
The PDS offers a new path forward.
- One implant.
- Refill every 24 weeks.
- Less stress.
- More convenience.
Key Findings From the TEIEN Study
Efficacy
- Mean change in BCVA at 24 weeks: –1.4 letters in the nAMD group.
- Results align with earlier global trials.
Safety
- Safety profile matched findings from overseas nAMD and DME studies.
- No unexpected issues reported.
Study Design at a Glance
- Japanese Phase I/II trial
- Two cohorts:
- 15 patients with nAMD
- 6 patients with DME - Primary endpoints:
- Safety and tolerability
- Change in BCVA at Week 24 (nAMD cohort)
How the PDS Works?
A small, surgically implanted reservoir slowly releases a custom ranibizumab formulation into the back of the eye. It includes four devices for fill, insertion, refill, or removal. This is Japan’s first system of its kind.
What it aims to do:
- Deliver consistent, long-term VEGF inhibition
- Reduce injection frequency
- Lower the overall treatment burden
- Improve adherence
- Support better long-term patient outcomes
The Bigger Picture: The Burden of nAMD and DME
nAMD
- Affects ~20 million people worldwide
- Leading cause of severe vision loss in people over 60
- Caused by abnormal vessel growth under the macula
DME
- Affects ~29 million people globally
- Linked to diabetes progression
- Leads to swelling of the macula and vision deterioration
- Growing problem as global diabetes numbers rise
What Chugai Plans Next?
Chugai intends to file a new drug application in Japan. This will include:
- TEIEN study results
- Data from Roche’s global Phase III trials:
- Archway (nAMD)
- Pagoda (DME)
Dr. Osamu Okuda, Chugai’s CEO, called the PDS a “major advancement” that may significantly reduce treatment burden for Japanese patients.
