ORBIT: A Phase IV Clinical Study – Efficacy and Safety Outcomes From Ocriplasmin Intravitreal Injection

Abstract

Purpose : The Phase 4 ORBIT Study (NCT02079883) was designed to observe the clinical outcomes and safety of patients receiving ocriplasmin in a real-world setting for the treatment of symptomatic VMA/ VMT.

Methods : ORBIT, a large, multicenter, prospective, observational study enrolled 539 patients across 90 retina clinics throughout the US. Patients were ≥18 years, diagnosed with symptomatic VMA/ VMT and treated with ocriplasmin at the physician’s discretion in a manner consistent with the US product label. Data were collected at Baseline visit (BL - day of 2.5 mg/mL ocriplasmin injection, per standard of care) and postinjection visits (at the discretion of the treating physician), and entered into electronic case report forms, based on investigators’ assessment. Spectral-domain optical coherence tomography (SD-OCT) images were uploaded to the central reading center (CRC) for independent review. Clinical outcome measures and safety parameters were collected for up to 12 months postinjection.

Results : Demographics were similar between those with VMA/VMT at BL (n=480) (per CRC) compared to all treated subjects (n=539); however, 10.9% (480/539) of all subjects did not have VMA/VMT based on the assessment of the CRC. Overall pharmacologic VMA/VMT resolution at Month 1 was 45.8% (220/480). Pharmacological VMA/VMT resolution improved over time to a rate of 59.0% (283/480) at Month 12. The FTMH closure rate was 30.5% (36/118) at Month 1 and 32.2% (38/118) at Month 12. Patients had a low rate of adverse drug reactions: 13.5% (73/539) experienced photopsia, 9.6% (52/539) vitreous floaters, and 6.7% (36/539) had reduced visual acuity. Serious adverse drug reactions were also low.

Conclusions : Overall VMA/VMT resolution at 1 month was higher than the MIVI-TRUST results (45.8% in ORBIT compared to 26.5% in MIVI-TRUST), demonstrating the importance of patient selection. No new safety signals were identified.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.