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Treatment with OpRegen® Continues to be Well Tolerated with Signs of Structural Improvement in the Retina and Decrease of Drusen Density Observed in Some Patients
Data presented at AAO showed that both the surgical procedure and the OpRegen® cells were generally well tolerated and there have been no unexpected adverse events or treatment-related systemic serious adverse events reported in the first fifteen patients enrolled into this Phase I/IIa safety and tolerability study. The most common and expected ocular adverse events were the formation of mild epiretinal membranes. One instance of retinal detachment occurred in a patient who was legally blind prior to treatment. The event was not able to be assigned as related to treatment, procedure, or to the combination and the patient continued in the study following successful surgical repair. Imaging of several Cohort 1-3 patients, and of particular interest, those from the Cohort 4 (n=3), demonstrated structural improvement within the retina and evidence of the continued presence of the transplanted OpRegen® cells. Within the area of the OpRegen® cell transplant, signs of a reduction and change in drusen material as well as improvements or possible restorations of the ellipsoid zone and retinal pigment epithelium (RPE) layers have persisted. The photoreceptor layer and ellipsoid zone assumed a more regular structural appearance in areas of the transition zone where OpRegen® was administered, suggesting potential structural restoration of the retina in areas receiving the RPE cells. This is of particular importance because in dry-AMD the structure of the retina can be impacted by the formation of excess drusen and ultimately death of RPE cells and photoreceptors, which are critical to sight. Other changes observed following OpRegen® treatment, persisted through the last time point examined (>3 years in some patients), included subretinal pigmentation and hyper-reflective areas seen on OCT.
The Best Corrected Visual Acuity (BCVA) and areas of geographic atrophy (GA) for patients have remained relatively stable thus far in both the treated and fellow eye. Notably, the visual acuity of the first 3 Cohort 4 patients have all seen improvements from baseline levels, which will need to be followed for longer periods of time. OpRegen®, which is currently enrolling Cohort 4 patients with less severe disease (i.e. smaller areas of GA and better vision acuity of between 20/64 and 20/250), appears well tolerated with preliminary evidence of improved structural changes and potential improvement in visual acuity following treatment in some patients.
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OpRegen® is a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, the leading cause of adult blindness in the developed world. OpRegen® consists of a suspension of retinal pigment epithelial (RPE) cells delivered subretinally as an intraocular injection. RPE cells are essential components of the back lining of the retina and function to help nourish the retina including photoreceptors. OpRegen® has been granted Fast Track designation from the
BioTime is a clinical-stage biotechnology company focused on the development and commercialization of novel therapies for the treatment of degenerative diseases. BioTime’s pipeline is based on two platform technologies which encompass cell replacement and cell/drug delivery. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy in Phase 2 development for the treatment of dry age-related macular degeneration, the leading cause of blindness in the developed world. BioTime’s lead cell delivery clinical program is Renevia®, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures. BioTime also has significant equity holdings in two publicly traded companies,
BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on Twitter, LinkedIn,