First Author: E.Wylęgała POLAND
Co Author(s):
Purpose:
To determine the efficacy and safety of a single intravitreal injection of ocriplasmin for pharmacologic resolution of vitreomacular traction (VMT).
Setting:
: The ocriplasmin MIVI-TRUST program included two phase 3, multicenter, randomized, double-masked, placebo-controlled trials.
Methods:
The ocriplasmin phase 3 program included 652 patients with optical coherence tomography (OCT)-detected vitreomacular adhesion (VMA) with associated symptomatology. Patients were randomized to receive a single intravitreal injection of placebo (n=188) or 125 µg ocriplasmin (n=464). Patients could proceed to vitrectomy after day 28 if deemed necessary by the investigator. The primary end point was VMA resolution confirmed by OCT at 28 days post-injection. Selected secondary end points included total posterior vitreous detachment (PVD) confirmed by B scan ultrasonography at 28 days post-injection (key secondary end point) and nonsurgical closure of full-thickness macular hole (FTMH). Safety assessments included adverse event reports and OCT examination.
Results:
Results from the two phase 3 trials were combined for an integrated analysis of efficacy and safety. Pharmacologic VMA resolution at day 28 was observed in a significantly larger proportion of patients in the ocriplasmin group (26.5%) versus placebo (10.1%; p < 0.001). Greater than 70% of responders in the ocriplasmin group had VMA resolution by 7 days post-injection. Total PVD at day 28 was observed in a significantly larger proportion of patients in the ocriplasmin (13.4%) group versus placebo (3.7%; p < 0.001). FTMH was detected at baseline by OCT in 22.8% of ocriplasmin patients and 25.0% of placebo. Nonsurgical FTMH closure at day 28 was observed in a greater proportion of patients in the ocriplasmin group (40.6%) versus placebo (10.6%). The most common suspected treatment related adverse events in study eye were vitreous floaters, eye pain, photopsia, and blurred vision. Most suspected treatment-related adverse events were non-serious, mild in severity, and occurred between day 0 and day 7 post-injection. No cases of endophthalmitis were reported.
Conclusions:
Treatment with a single intravitreal injection of ocriplasmin demonstrated efficacy in VMA resolution in a phase 3 clinical trial program. Ocriplasmin was well-tolerated and most suspected drug-related adverse reactions were non-serious, transient, and mild in severity. Ocriplasmin may be the first pharmacologic treatment option for patients with VMT.
Financial Disclosure:
None
