The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment- emergent adverse events. Secondary objectives are to evaluate the potential activity of OpRegen by assessing changes in visual function and retinal structure. The primary objective and the secondary objectives were assessed at 12 months following OpRegen subretinal delivery (“Month 12”) and subjects are followed for up to five years.
Summary of Safety Results (data cutoff: January 18, 2022)
? All 24 treated patients reported at least one adverse event (“AE”) and at least one ocular AE.
? The majority of AEs reported with OpRegen were mild (Cohorts 1-3, 87%; Cohort 4, 93%), and the immunosuppressive regimen was well tolerated.
? The ocular AEs reported with OpRegen were mainly related to the surgical procedures used for subretinal delivery, with the most common being conjunctival hemorrhage/hyperemia (n=17) and epiretinal membrane (n=16).
? One patient discontinued the study due to an AE that was determined unrelated to treatment.
? No cases of rejection following OpRegen subretinal delivery have been reported.
? No acute or delayed intraocular inflammation, or sustained intraocular pressure increase following OpRegen subretinal delivery has been observed.
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Summary of Activity Results (data cutoff: January 18, 2022)
? Preliminary evidence of improvement in visual function using the Early Treatment Diabetic Retinopathy Study (“ETDRS”) assessment of BCVA:
? Cohort 4 subjects (n=12) had an average 7.6 letter gain in the study (treated) eye and an average 1.7 letter gain in the fellow (untreated) eye at Month 12 compared to baseline. Cohorts 1-3 subjects (n=11) had an average 4.7 letter gain in the study eye and an average 6.0 letter gain in the fellow eye at Month 12 compared to baseline.
? Three subjects in Cohort 4, or 25% of Cohort 4, and one subject in Cohorts 1-3 had a 15 letter or greater gain in the study eye at Month 12 compared to baseline. None of the fellow (untreated) eyes had a 15 letter or greater gain.
? Five Cohort 4 subjects with OpRegen delivered to most or all of the GA area, including the fovea, had greater gains in visual function at Month 12 (average 12.8 letter gain) as compared with subjects who did not receive OpRegen in a similar manner to most or all of the GA area, with evidence for regions of apparent improvement of outer retinal structure as assessed by spectral domain optical coherence tomography (“SD-OCT”).
? SD-OCT imaging analysis of all subjects is ongoing.
These data support the potential for OpRegen to slow, stop, or reverse disease progression in GA. Further assessment of the optimal disease stage for intervention, surgical procedure for subretinal delivery, and target delivery location of OpRegen in a larger, controlled clinical study is needed to confirm these preliminary findings.
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