A cataract is opacity of the lens of the eye that
causes partial or total blindness. Cataract formation typically is bilateral,
although it is often asymmetrical. Most cases of cataract occur in patients
over age 60 or in younger individuals who have risk factors such as diabetes
mellitus systemic steroid use, or a history of significant eye trauma. The only
treatment for cataract is to surgically remove the opacified lens from the eye
to restore transparency of the visual axis.
Bromfenac is a non-steroidal anti-inflammatory
drug (NSAID) that has anti-inflammatory activity. The mechanism of its action
is thought to be due to its ability to block prostaglandin synthesis by
inhibiting cyclooxygenase 1 and 2. Bromfenac 0.09% ophthalmic solution is
indicated for the treatment of postoperative inflammation and reduction of
ocular pain in patients who have undergone cataract extraction. Potential
off-label uses include ocular allergy and reduction of post-cataract cystoid
macular edema (CME). The recommended dosage for the treatment of postoperative
inflammation in patients who have undergone cataract extraction is one drop
into the affected eye(s) twice daily beginning 24 hour after cataract surgery
and continuing through the first two weeks of the post-operative period.
The most common adverse events reported following
the use of Bromfenac 0.09% ophthalmic solution after cataract surgery included irregular
feeling in eye, Conjunctival Hyperemia, eye impatience (includingburning/cutting),
eye sting, headache, eye redness, eye pruritus and iritis. These actions were
reported in 2% to 7% of patients. Transient burning and stinging of ketorolac
and diclofenac are 40%and 15% but incase of bromfenac it is only 1.4%.
FDA approval was based on the results of two
unpublished, double blind, placebo-controlled studies using bromfenac 0.1%
ophthalmic solution. These studies were performed in patients who had undergone
cataract surgery and had baseline postoperative inflammation [summed
(cell plus flare ) ocular lnflammation score (SOIS) of 3 or greater].
They were randomly assigned therapy with either bromfenac sodium 10%
ophthalmic solution or placebo twice daily for 14 days starting the
day after surgery. Therapy was initiated 16 to 32 hours after surgery. Mean
baseline SOIS was 3.7.Efficacy assessments were completed on days 3,8,15,22,
and 29.The primary endpoint of both studies was the percent of patients
achieving treatment success, defined as the complete absence of ocular
inflammation. Secondary efficacy endpoints included mean change from baseline
for SOIS prior to receipt of any rescue medication and time to resolution of
ocular pain. In one study enrolling 296 patients, ocular inflammation was
absent in 62.6% of bromfenac-treated patients compared with 39.8% of placebo-treated
patients at 15 days (P< 0.01). Among patients who received no other
medications, inflammation cleared in 57.6% treated with bromfenac compared with
23.5% treated with placebo. In the other study enrolling 231 patients, ocular
inflammation was absent in 65.8% of bromfenac-treated patients and 47.9% of
placebo-treated patients at 15 days (p< 0.01). Among patients in this study
who received no other medication inflammation cleared in 62% treated with
bromfenac compared with 31. 5%treated with placebo. For the combined study
population, the meanchange in SOISfrom baseline wassignificant on days 3,8, and
15 following initiation of therapy. The mean change was 1.4 with
bromfenac compared with 0.9 with placebo on day 3(p<0.0002), 2.4 with
bromfenac compared with l. I with placebo on day 8 (p<0.0001), and 2.9 with
bromfenac compared with 1.5 with placebo on day 15(p<0.0001). The mean
number of days to resolution of ocular pain was 1.9 days with bromfenac
compared with 5.9 days for placebo (p<0.0001).
Bromfenac0.09% ophthalmic solution dosed twice
daily likely has improved adlherence over formulary agents which are dosed four
times a day. Bromfenac 0.09% ophthalmic solution also has a lower
incidence of burning and stinging following administration compared to
ketorolac and diclofenac ophthalmic solutions.
Recently, The IBN SINA Pharmaceutical Industry
Limited is going to introduce bromfenac eye drops for better treatment of
ocular inflammation.
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