Research Digest

Combination AMD Treatment Evaluated

A 60-patient retrospective case control study evaluated the adjuvant use of bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals) in ranibizumab (Lucentis, Genentech) treatment of choroidal neovascularization secondary to AMD in an attempt to see if bromfenac could possibly modulate the duration of ranibizumab treatment. The study found that the combination treatment achieved a statistically significant improvement in visual acuity (VA) with fewer injections of ranibizumab.

The researchers, who presented the findings at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in May, reported that 30 patients who received bromfenac in addition to ranibizumab required 1.6 +/–0.69 injections of ranibizumab during the 6-month study. The 30 patients who received only ranibizumab received 4.5 +/–0.41 injections.

While the original abstract (published by ARVO in Feb. 2008) stated though there was a numerical trend in favor of the combination group on improvement in VA, this difference did not achieve statistical significance. New data has contradicted this finding. Lead investigator Calvin A. Grant, M.D., reported that further statistical analysis showed that the combination group did show a statistically significant improvement in VA: an increase in mean VA of 1.2 +/–1.64 lines compared with 0.06 +/–0.66 lines in patients in the Lucentisonly group.

The patients had been monitored monthly using optical coherence tomography (OCT), fluorescein angiography and VA assessment. When OCT detected subretinal fluid from leaking vessels, patients were reinjected with ranibizumab. Researchers found no adverse events associated with extended topical administration of bromfenac. "The use of bromfenac 0.09% ophthalmic solution reduced the number of Lucentis injections needed to control the disease by a factor of 2.83," the researchers wrote.

The study was supported by an unrestricted educational grant from ISTA Pharmaceuticals. OM

Topical Steroid Successful in Treatment of Postop Inflammation

Two Phase 3 clinical trials of difluprednate ophthalmic emulsion 0.05% (Durezol, Sirion Therapeutics) evaluating the safety and efficacy of the drug compared with placebo were presented at the 2008 American Society of Cataract and Refractive Surgery Annual Symposium in April. The multi-site study compared difluprednate with placebo dosed b.i.d. and q.i.d. in 438 subjects, beginning 24 hours after ocular surgery. Subjects presented with anterior chamber cell grade 2 (≥10 cells) or higher.

Researchers demonstrated that difluprednate was superior to placebo in achieving the primary endpoint of an anterior chamber cell grade of 0 (≤ one cell) both at b.i.d. and q.i.d. dosings: On day 8, 30% of the subjects in the b.i.d. group reached grade 0 vs. 9% in the placebo group. In the q.i.d. group, 35% reached grade 0. The mean reduction in cell count for subjects in both difluprednate dosings was 19 cells vs. a mean reduction of six cells for the placebo group.

Throughout the treatment period (day 15), difluprednate maintained greater efficacy over placebo, with 56% of the b.i.d. and 63% of the q.i.d. group reaching grade 0 vs. 16% in the placebo group. Further, the proportion of subjects who reached "clinical cure" — an anterior chamber cell count ≥ 5 and flare score of 0 — at day 15 was 73% in the b.i.d. group and 71% in the q.i.d. group vs. 27% in the placebo group.

Difluprednate also was superior to placebo in eliminating postoperative pain (as measured using the Visual Analogue Scale).

Finally, the researchers, led by Michael Korenfeld, M.D., reported that mean IOP for all study groups remained within the normal range throughout the study period and that the drug was well-tolerated. OM