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Treatment with OpRegen® Continues to be Well Tolerated with Signs of Structural Improvement in the Retina Observed in Some Patients
Data presented at ARVO 2019 showed that both the surgical procedure and the OpRegen cells were generally well tolerated with no unexpected adverse events or treatment-related systemic serious adverse events reported in the first fifteen patients enrolled to date. The most common and expected ocular adverse events were the formation of mild epiretinal membranes (ERM). 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. One instance of a severe ERM required surgical removal, which was successful, and the subject continues to demonstrate improved visual acuity from baseline following OpRegen administration.
Imaging of several patients from Cohorts 1, 2 and 3, and of particular interest, those from Cohort 4 (n=3) with better baseline vision, demonstrated sustained structural improvement within the retina and evidence of the continued presence of the transplanted OpRegen cells. Within the area of the OpRegencell transplant, signs of a reduction and change in drusen material, as well as improvements or possible restorations of the ellipsoid zone and 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 (up to 3 years) and included subretinal pigmentation and hyper-reflective areas seen on optical coherence tomography (OCT). Additionally, asymmetrical, reduced growth of GA in the treated areas receiving OpRegen was observed in some subjects. These observations are being independently evaluated by the
The Best Corrected Visual Acuity (BCVA) and areas of GA continued to remain largely stable in the treated eyes. Notably, the visual acuity of the first three Cohort 4 patients with better baseline vision have all seen improvements from baseline levels and will be followed for longer periods of time. Overall, OpRegen appears well-tolerated with preliminary evidence of improved structural changes and potential improvement in visual acuity following treatment observed in some patients.
OpRegen is a RPE transplant therapy in Phase I/IIa development for the treatment of dry AMD, the leading cause of adult blindness in the developed world. OpRegenconsists of a suspension of 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 Inc. IR
Ioana C. Hone
Solebury Trout IR
Gitanjali Jain Ogawa