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Progress in Clinical Trials for Macular Degeneration

Regenerative Patch Technologies LLC (RPT) has made a significant advancement in its clinical development journey. Recently, the company announced the treatment of its first two participants in a Phase IIb clinical trial designed to evaluate the safety and efficacy of its allogeneic bioengineered RPE cell implant for patients suffering from advanced dry age-related macular degeneration (AMD).

About the Clinical Trial

The trial, titled "A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Patients with Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) – PATCH AMD," aims to build upon the data gathered from RPT's previous Phase I/IIa study. This new trial focuses on generating additional safety and efficacy data from a larger cohort of subjects, targeting patients with less severe manifestations of the disease.

In the earlier Phase I/IIa study, which monitored participants for an average of 36.9 months, results were promising: 27% of the treated eyes showed a visual acuity improvement of more than 5 letters compared to only 7% in the untreated eyes. Additionally, a significantly higher proportion of non-implanted eyes experienced vision loss, suggesting the implant may play a crucial role in stabilizing vision for patients with advanced AMD.

Expert Insights

Jane Lebkowski, PhD, RPT's President, emphasized the importance of the Phase IIb trial, stating, "Initiation of the Phase IIb clinical trial marks an important milestone for RPT. Based on our initial trial results, this new phase presents an invaluable opportunity to collect vital clinical data in patients with earlier stages of the disease, helping validate our implant's potential to enhance vision."

The trial's Chief Scientific Officer, Linc Johnson, PhD, discussed the advantages of utilizing a cryopreserved formulation of the implant in this trial. This storage method allows for easy shipment to various clinical sites, where the implant can be thawed right before implantation, ensuring optimal application.

Suber Huang, MD, MBA, FASRS, CEO of the Retina Center of Ohio, expressed enthusiasm about the trial's potential to provide a groundbreaking treatment option. "To date, the only available therapies for geographic atrophy require patients to undergo frequent eye injections that merely slow lesion progression. Developing a treatment that can safely improve vision is a major leap forward for ophthalmology."

Global Clinical Development

The Phase IIb trial is taking place concurrently at multiple locations in California, Illinois, and Texas, showcasing RPT’s commitment to expanding access to innovative treatment options for patients facing vision loss.

In support of this initiative, RPT extends its gratitude to key funding sources, including the California Institute for Regenerative Medicine (CIRM), the Marcus Foundation, and the University of Southern California, whose contributions have been invaluable in advancing this clinical program.

About RPT and Its Vision Treatments

Regenerative Patch Technologies is focused on creating cutting-edge therapies for retinal diseases. Their leading product, the CPCB-RPE1 implant, is engineered from stem-cell-derived retinal pigmented epithelial (RPE) cells, structured on a minimally invasive synthetic parylene membrane. The implant is intended to substitute damaged RPE and Bruch’s membrane in patients with dry AMD.

Dry age-related macular degeneration accounts for 90% of AMD cases and is a significant cause of blindness among the elderly population, particularly affecting 10-20% of individuals over the age of 65 in the United States. By targeting the heart of the degenerative process and restoring critical support for retinal health, the CPCB-RPE1 implant aims to revolutionize treatment options available to this patient demographic.

To learn more about the clinical trial, visit clinicaltrials.gov.

With these advancements, RPT is poised to make a meaningful impact in the fight against advanced dry age-related macular degeneration, offering hope to countless patients suffering from this debilitating condition.