Regenerative Patch Technologies (RPT) has treated the first two participants in a clinical trial assessing its allogeneic bioengineered retinal pigment epithelium cell implant for advanced dry age-related macular degeneration.

The Phase 2b multicentre study is designed to generate safety and efficacy data from additional subjects, adding to the dataset from previously completed trials.

In that earlier trial, patients were followed for a mean of 36.9 months (range 12–54 months). As of final follow up, 27% of treated eyes showed a >5 letter gain in visual acuity compared to 7% of the untreated fellow eyes. A larger proportion of non-implanted eyes demonstrated >5 letter vision loss (80% vs 47%) compared to that of the treated eye.

Patients enrolled in the Phase 2b trial will have less severe disease to confirm the implant’s ability to improve vision.

“The Phase 2b clinical trial incorporates use of a cryopreserved formulation of the implant” said Dr Linc Johnson, Chief Scientific Officer of RPT. “This long-term storage format facilitates shipment to clinical treatment sites where it is thawed immediately before implantation.”

United States ophthalmologist Dr Suber Huang, said to date the “only treatments available to patients with geographic atrophy involve frequent injections in the eye which simply slow growth of the lesion”.

“The development of a therapy that safely improves vision would be a major breakthrough for the field.”

Further details can be found at clinicaltrials.gov/study/NCT06557460.