EW CATARACT
40
May 2017
that's NOT covered is the cost of
the toric implant and some of the
testing we have to do to make it
work. That portion is .
"I'm happy to do your surgery
either way, but I want you to under-
stand that this is a choice you make
once, and whatever you choose,
you're going to look through that
implant for the rest of your life.
We can't upgrade your implant
later, so I encourage you to think of
this as a long-term decision. I think
if you can afford it, it's worth having
a toric implant because it improves
your vision permanently and
doesn't require any more surgery—
just a more advanced, customized
implant. If you can't afford it, don't
worry because you're still going to
have better vision because of your
cataract surgery, even if you need
glasses."
Next, I hand the patient over to
my surgical counselor.
Nicole Fram, MD
Clinical instructor, Jules Stein Eye Institute,
UCLA, Los Angeles
Discussing astigmatic manage-
ment can be a daunting task for
both the surgeon and the pa-
tient as it requires a foundation of
knowledge that can be conceptu-
ally challenging for the patient to
grasp. I have found the most critical
determinant of patient satisfaction
after cataract surgery is establishing
a therapeutic relationship with your
patient to decrease anxiety sur-
rounding surgery and realistic expec-
tations of visual outcomes.
When counseling patients
about cataract surgery I prefer to
use a visual aid on my iPad (Ren-
dia, formerly eyemaginations,
Baltimore) and provide a concep-
tual understanding of the proce-
dure. I begin by explaining the an-
atomical location of the cataract in
the eye and establish a base working
knowledge. I state:
"A cataract is part of the ag-
ing process where the lens in your
eye becomes cloudy and scatters
incoming light. This is why you
are having difficulty seeing. Cat-
aract surgery involves replacing
your cloudy lens with a clear artifi-
cial intraocular lens. Imagine that
the lens is shaped like an M&M and
during surgery we open up the shell
of the M&M, break up and vacu-
um out the chocolate and place a
new artificial lens in the confines of
the shell." I then say that, "We are
able to tell the artificial lens where
to focus. In order to reach our goals
of distance, near or both, we need to
make the light rays focus properly."
I then move on to the concept
of astigmatic correction. When
talking about the benefits of toric
IOL implants to patients, I begin
by explaining, "The eye has two
systems that bend light to al-
low for proper focus at a desired
distance, the cornea and the lens.
The cornea can be shaped like a
perfect sphere, or more common-
ly, like a football where light rays
are bent to focus in different loca-
tions depending where they hit the
surface; this is what we call corne-
al astigmatism. Once we remove
your natural cloudy lens, we are left
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to prescribe
Prolensa safely and effectively. See full prescribing information for Prolensa.
PROLENSA (bromfenac opthalmic solution) 0.07%
Rx only
Initial Rx Approval: 1997
INDICATIONS AND USAGE
PROLENSA
®
(bromfenac ophthalmic solution) 0.07% is indicated for the treatment
of postoperative inflammation and reduction of pain in patients who have undergone
cataract surgery.
DOSAGE AND ADMINISTRATION
Recommended Dosing
One drop of PROLENSA ophthalmic solution should be applied to the affected eye
once daily beginning 1 day prior to cataract surgery, continued on the day of surgery,
and through the first 14 days of the postoperative period.
Use with Other Topical Ophthalmic Medications
PROLENSA ophthalmic solution may be administered in conjunction with other topical
ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase
inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5
minutes apart.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Sulfite Allergic Reactions
Contains sodium sulfite, a sulfite that may cause allergic-type reactions including
anaphylactic symptoms and life-threatening or less severe asthmatic episodes in
certain susceptible people. The overall prevalence of sulfite sensitivity in the general
population is unknown and probably low. Sulfite sensitivity is seen more frequently in
asthmatic than in non-asthmatic people.
Slow or Delayed Healing
All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may
slow or delay healing. Topical corticosteroids are also known to slow or delay healing.
Concomitant use of topical NSAIDs and topical steroids may increase the potential for
healing problems.
Potential for Cross-Sensitivity
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid
derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be
used when treating individuals who have previously exhibited sensitivities to these
drugs.
Increased Bleeding Time
With some NSAIDs, including bromfenac, there exists the potential for increased
bleeding time due to interference with platelet aggregation. There have been
reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues
(including hyphemas) in conjunction with ocular surgery.
It is recommended that PROLENSA ophthalmic solution be used with caution in
patients with known bleeding tendencies or who are receiving other medications
which may prolong bleeding time.
Keratitis and Corneal Reactions
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued
use of topical NSAIDs may result in epithelial breakdown, corneal thinning,
corneal erosion, corneal ulceration, or corneal perforation. These events may be
sight threatening. Patients with evidence of corneal epithelial breakdown should
immediately discontinue use of topical NSAIDs, including bromfenac, and should be
closely monitored for corneal health.
Post-marketing experience with topical NSAIDs suggests that patients with
complicated ocular surgeries, corneal denervation, corneal epithelial defects,
diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid
arthritis, or repeat ocular surgeries within a short period of time may be at increased
risk for corneal adverse events which may become sight threatening. Topical NSAIDs
should be used with caution in these patients.
Post-marketing experience with topical NSAIDs also suggests that use more than 24
hours prior to surgery or use beyond 14 days post-surgery may increase patient risk
for the occurrence and severity of corneal adverse events.
Contact Lens Wear
PROLENSA should not be instilled while wearing contact lenses. Remove
contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA,
benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be
reinserted after 10 minutes following administration of PROLENSA.
ADVERSE REACTIONS
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared to
rates in the clinical trials of another drug and may not reflect the rates observed in
clinical practice.
The most commonly reported adverse reactions following use of PROLENSA
ophthalmic solution following cataract surgery include: anterior chamber
inflammation, foreign body sensation, eye pain, photophobia and vision blurred.
These reactions were reported in 3 to 8% of patients.
USE IN SPECIFIC POPULATIONS
Pregnancy
Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the
systemic exposure predicted from the recommended human ophthalmic dose [RHOD]
assuming the human systemic concentration is at the limit of quantification) and
rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic
exposure) produced no treatment-related malformations in reproduction studies.
However, embryo-fetal lethality and maternal toxicity were produced in rats and
rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac
treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted
human exposure), and caused dystocia, increased neonatal mortality, and reduced
postnatal growth at 0.9 mg/kg/day.
There are no adequate and well-controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the
fetal cardiovascular system (closure of ductus arteriosus), the use of PROLENSA
ophthalmic solution during late pregnancy should be avoided.
Nursing Mothers
Caution should be exercised when PROLENSA is administered to a nursing woman.
Pediatric Use
Safety and efficacy in pediatric patients below the age of 18 have not been
established.
Geriatric Use
There is no evidence that the efficacy or safety profiles for PROLENSA differ in
patients 70 years of age and older compared to younger adult patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up
to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from
the recommended human ophthalmic dose [RHOD] assuming the human systemic
concentration is at the limit of quantification) and 5 mg/kg/day (340 times the
predicted human systemic exposure), respectively, revealed no significant increases
in tumor incidence.
Bromfenac did not show mutagenic potential in various mutagenicity studies,
including the reverse mutation, chromosomal aberration, and micronucleus tests.
Bromfenac did not impair fertility when administered orally to male and female rats at
doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90
and 30 times the predicted human exposure, respectively).
PATIENT COUNSELING INFORMATION
Slowed or Delayed Healing
Advise patients of the possibility that slow or delayed healing may occur while using
NSAIDs.
Sterility of Dropper Tip
Advise patients to replace bottle cap after using and to not touch dropper tip to any
surface, as this may contaminate the contents. Advise patients that a single bottle of
PROLENSA be used to treat only one eye.
Concomitant Use of Contact Lenses
Advise patients to remove contact lenses prior to instillation of PROLENSA. The
preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact
lenses. Lenses may be reinserted after 10 minutes following administration of
PROLENSA.
Concomitant Topical Ocular Therapy
If more than one topical ophthalmic medication is being used, the medicines should
be administered at least 5 minutes apart.
Rx Only
Manufactured by:
Bausch + Lomb, a division of Valeant Pharmaceuticals
North America LLC, Bridgewater, NJ 08807 USA
Product under license from:
Senju Pharmaceutical Co., Ltd., Osaka, Japan 541-0046
Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated
Revised: 06/2016
Based on: 9306701/9306801 PRA.0119.USA.16
Astigmatism continued from page 39
