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Allergan's Trivaris injections may slow diabetic retinopathy, though laser therapy remains treatment of choice, investigators conclude

Wednesday, January 20 2010 | Comments

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What's This? Allergan Inc.'s corticosteroid Trivaris (trimcinolone acetonide) injectable suspension may reduce the risk of progression of diabetic retinopathy through three years, but use of this treatment cannot be warranted due to adverse events, a new analysis finds.

Researchers conducted an exploratory analysis of a trial by the Diabetic Retinopathy Clinical Research Network, in which 840 eyes from 693 patients (mean age, 63 years) with diabetic macular edema were randomized to receive focal/grid photocoagulation (n=330), 1 mg of intravitreal Trivaris as often as every four months (n=256) or 4 mg of Trivaris as often as every four months (n=254). Overall, 73 percent of the eyes had nonproliferative diabetic retinopathy.

A previous analysis showed that the laser therapy was more effective with fewer side effects than the Trivaris steroid treatment was after two years of follow-up. The current analysis assessed the impact of Trivaris on the progression of retinopathy for up to three years.

At one year, the cumulative probability of retinopathy progression was 21 percent for the laser group, 19 percent for the Trivaris 1 mg group and 14 percent for the Trivaris 4 mg group. At two years, the respective cumulative probabilities were 31 percent, 29 percent and 21 percent. At three years, the differences between the groups were sustained, as the cumulative probability of retinopathy progression in the three groups was 37 percent, 35 percent and 30 percent, respectively. The researchers noted that during the second year, most eyes did not receive corticosteroids every four months, and less than 50 percent received any corticosteroids during the third year.

The investigators stressed that even though the 4 mg dose of Trivaris reduced the risk of retinopathy progression relative to the laser treatment, its use cannot be recommended because intravitreal steroid use is linked with a higher risk of glaucoma and cataract.

"Any treatment to be used routinely to prevent proliferative diabetic retinopathy needs to be relatively safe because the condition already can be treated successfully and safely with panretinal photocoagulation," the researchers wrote. "Nevertheless, further investigation with regard to the role of pharmacotherapy for reduction of the incidence of progression of retinopathy appears to be warranted." 

The data were published in the December issue of Archives of Ophthalmology.

This information concerns a use that has not been approved by the Food and Drug Administration.

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