A Phase III trial of a drug used for the treatment of vitreomacular adhesion (VMA) and macular hole (MH) revealed key findings for patients diagnosed with these severe conditions which can lead to significant vision impairment.
Dr. Matthew Benz, retinal surgeon at The Methodist Hospital in Houston, presented the data of the microplasmin trial (TG-MV-006) on behalf of ThromboGenics NV, at the World Ophthalmology Congress in Berlin yesterday.
The trial recruited 326 patients at 42 centers in the United States, and Benz is the primary investigator at Methodist. In his presentation, Benz reported that in the study, 27.7 percent of the 220 patients treated with the in-office injection of microplasmin had their VMA corrected, compared to 13.2 percent of the 106 patients who received a placebo injection. Untreated, VMA can cause distortion and blurring of central vision. Current treatment includes either observation or surgery.
The TG-MV-006 study confirmed that microplasmin was generally safe and well tolerated with no increase in the rate of retinal tear or detachment in comparison to the placebo. Study investigators also discovered that patients diagnosed with certain types of macular holes, a severe condition which can lead to irreversible vision impairment including central blindness, could benefit from the same drug.
In this group, 45.6 percent of the 52 patients with smaller macular holes were cured with a single injection of microplasmin without the need for eye surgery in the six months after treatment. This compared with 15.6 percent of the 32 patients in the placebo group.
"The ability to cure a significant proportion of patients with a range of retinal disorders, including macular hole, with a simple injection of microplasmin is clearly an attractive alternative to the current option of surgery," said Benz.
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