SAN DIEGO — Many patients suffer adverse effects after being treated for vitreomacular adhesion with ocriplasmin (Jetrea, ThromboGenics), a survey of specialists shows.
"Enzymatic effects of ocriplasmin may not be limited to the vitreous body," said Sumit Shah, MD, from NJ Retina in New Brunswick, New Jersey, who presented the findings here at the 32nd Annual Meeting of the American Society of Retina Specialists (ASRS).
Ocriplasmin is a recombinant protease with activity against fibronectin and laminin. Soon after the injectable was approved by the US Food and Drug Administration (FDA) in October 2012, reports linked ocriplasmin to acute transient visual dysfunction, which appears to resolve in some, but not all, patients.
To get a better understanding of the incidence of such adverse events, Dr. Shah and his team surveyed 2465 retinal physicians using the Web-based SurveyMonkey. They received responses from 270 physicians — 11% of the total — who reported treating 1056 eyes with ocriplasmin.
The respondents were well distributed across the United States, 91.5% were male, 49% were in group retina practice, 23% were in multispecialty group practice, 16% were in full-time academic practice, and 11% were in solo private practice.
The specialists reported 179 cases of acute decline in visual acuity — an incidence rate of 16.95%. In contrast, the prescribing information from ThromboGenics states that "a decrease of ≥3 lines of best corrected visual acuity was experienced by 5.6% of patients treated with [ocriplasmin] and 3.2% of patients treated with vehicle in the controlled trials."
The surveyed doctors reported a range of adverse effects; however, only 15.9% of physicians who noted an adverse event said they reported the incident to the FDA.
Table. Adverse Events With Ocriplasmin
|Submacular fluid or serous retinal detachment||10.23|
|Progression of vitreomacular traction to macular hole||8.71|
|Afferent pupillary defect||1.80|
|Crystalline lens instability||0.38|
The study had several limitations, Dr. Shah acknowledged. It was limited to what physicians recalled, so important findings might have been left out. Also, physicians might have been more likely to respond to the survey if they had an adverse reaction to report, which could have biased the incidence rate.
Still, on the basis of these findings, Dr. Shah urged physicians to discuss potential problems with their patients as part of the informed-consent process. He also encouraged physicians to report adverse events to the FDA through the ASRS Therapeutic Surveillance Committee.
Ocriplasmin remains an important option, said session moderator Marcos Avila, MD, professor of ophthalmology at the Federal University of Goias in Sao Paulo, Brazil, who was not involved in the study.
"I think ocriplasmin has changed the way we are going to manage patients with macular holes associated with vitreomacular traction," he told Medscape Medical News.
It is too early to draw conclusions from the reports of adverse events, noted Dr. Avila. "It's still not clear whether the adverse events are new because of the drug, or something else going on in the back of the eye," he explained.
Dr. Avila reports a financial relationship with Ophthotech.
32nd Annual Meeting of the American Society of Retina Specialists (ASRS). Presented August 11, 2014.
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Cite this: Retina Specialists Report Problems With Ocriplasmin - Medscape - Aug 12, 2014.