July 12, 2019

Stem Cell Treatment for Dry AMD Fast-tracked by FDA

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Stem Cell Treatment for Dry AMD Fast-tracked by FDA

It was reported here in March 2017 that BioTime, Inc. is conducting a Phase I/IIa clinical trial for OpRegen® for treatment of dry AMD. OpRegen is a retinal pigment epithelium (RPE) stem cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). RPE cells are essential components of the back lining of the retina and function to help nourish the retina including photoreceptors. The transplanted cells under study are derived from human embryonic stem cells.

Data presented by the company in May 2019 showed that both their surgical procedure and the OpRegen cells have been generally well-tolerated and that signs of structural improvement and increased visual acuity have been observed. Due to these positive results, the research has been granted Fast Track designation from the FDA.

Latest news from BioTime is that it has dosed its first patient with their Orbit Subretinal Delivery System (Orbit SDS) as well as with a new Thaw-and-Inject (TAI) formulation of OpRegen, which can be shipped directly to clinics and used upon thawing. This removes the complications and logistics of having to use a dose preparation facility. 

Orbit SDS was designed to help surgeons deliver therapies to the retina with precision and accuracy. To deliver a therapy to the retina a surgeon would traditionally perform a vitrectomy and remove the gel-like substance (the vitreous) that fills the eye. Then the therapy is injected into the eye through the retina, a process called a retinotomy. The Orbit SDS avoids the need for a vitrectomy and perforation of the retina. The goal is to simplify surgical procedures to make the administration safe and consistent to give the medicine the best chance of working.

For more information, visit BioTime, Inc.

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