October 10, 2011
InSite Vision reported results from a phase II trial of BromSite, their low dose formulation of bromfenac for the reduction of pain and inflammation associated with ocular surgery. This randomized, double-masked, two-arm study was designed to compare the tissue penetration profile of BromSite versus Bromday, a high dose of bromfenac and the current standard of care. The trial enrolled 58 subjects who were dosed two days before and the morning of the day of cataract surgery. Study results showed that the mean concentration of bromfenac in the aqueous humor of subjects in the BromSite group was more than twice greater compared to subjects in the Bromday group (p≡0.0032).
March 28, 2011
InSite Vision released results from a phase I/II trial of ISV-303 for the reduction of pain and inflammation associated with ocular surgery. The randomized, placebo-controlled study enrolled 160 subjects who were placed in one of four study arms: ISV-303 administered once-daily or twice-daily, Xibrom (standard of care) administered twice-daily, or placebo. The drug therapy was administered for two weeks following an ocular surgery procedure. The primary endpoint was the absence of cells in the anterior chamber of the eye at day 15 post surgery. Once-daily ISV-303 achieved statistically significant superiority compared to placebo (53.3% versus 19%; p≡0.0016) for the primary endpoint. Secondary endpoints, including reduction of flare, pain and discomfort, also achieved statistical significance compared with placebo. While once-daily ISV-303 achieved a numerically superior difference in the primary endpoint versus twice-daily Xibrom (53.3% versus 42.2%), the results did not reach statistical significance. ISV-303 was well tolerated.
February 28, 2011
Isis released results from a phase I trial of ISIS CRPRx, under development for the treatment of inflammatory and cardiovascular disorders. The blinded, randomized, placebo-controlled, dose-escalation study enrolled 80 healthy subjects who received single and multiple doses ranging from 50 mg per week to 600 mg per week. In all but one cohort, the subjects had normal (generally undetectable to less than 2 mg/L) CRP levels. In the 600 mg per week multi-dose cohort, eight subjects with elevated levels of CRP were enrolled. The subjects enrolled in this cohort had an average CRP level at baseline of approximately 3.0 mg/L. After three weeks of dosing, the six subjects who received ISIS-CRPRx had an average CRP level of 0.76 mg/L, which is within the normal range of CRP and represents an average reduction of greater than 70% compared to placebo. Subjects receiving placebo remained elevated above 3.0 mg/L. ISIS-CRPRx was well tolerated in all cohorts, with no serious adverse events.