Lifelong Contact Lens Success: Keep Allergy and Dry Eye at Bay, Page 48 New therapies under

108 Pages·2017·16.4 MB·English

Lifelong Contact Lens Success: Keep Allergy and Dry Eye at Bay,
Page 48
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■ New therapies under investigation have the potential to radically alter

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8TH ANNUAL
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RETINA REPORT
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C • Diabetes Care in the Age of Anti-VEGF, Page 56
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N • Advanced Imaging Techniques for Choroidal Disease, Page 62
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S • Case Report: Acute Syphilitic Posterior Placoid Chorioretinitis, Page 70
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• AMD Mimickers: When to Suspect Macular Dystrophy, Page 81
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NEW
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vent Planner Soccer P l a y e r
Because I know Eric leaves no detail unchecked,
I prescribe NEW ACUVUE OASYS® 1-Day for ASTIGMATISM.
*Helps protect against transmission of harmful UV radiation to the cornea and into the eye.
†WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses
because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE:
Long-term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as
environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-blocking contact
lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-
blocking contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information.
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1. Straker B, Hamada W, Sulley A, Olivares G. Fitting performance and effi ciency with a low silicone hydrogel daily disposable toric contact
lens. Poster presented at: GSLS Conference 2017.
ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can
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N e w s R e v i e w
VOL. 154 NO. 6 ■ JUNE 15, 2017
Systemic Therapy vs.
IN THE NEWS
Implant for Uveitis
Bausch + Lomb recently announced
updated results from the ARMOR
surveillance study, including preliminary
2016 data on antibiotic resistance Long-term follow up reveals systemic therapy may be
levels and an eight-year trend analysis of
better for chronic uveitis patients.
antibiotic resistance among staphylococ-
cal isolates. They found non-susceptibility By Rebecca Hepp, Managing Editor
to fl uoroquinolones more than doubled
from 2015, and methicillin resistance Patients with chronic uve- risk of needing treatment with anti-
is decreasing among S. aureus, but not itis may consider systemic biotics, did not have large increases
among coagulase-negative staphylo- therapy with corticosteroids in the risk of adverse effects com-
cocci. While resistance is decreasing, and immunosuppressants in lieu of mon with systemic corticosteroids
resistance to several commonly used a long-term corticosteroid intra- such as high blood pressure or
antibiotics is still a challenge, accord- ocular implant, according to new diabetes.
ing to Penny Asbell, MD, lead author. research. The study, funded by the “This study now clearly states
National Eye Institute, found that, that systemic oral therapy is just as
Bausch + Lomb Reports Updated Results of the Antibi-
otic Resistance Monitoring in Ocular MicRoorganisms after seven years of treatment, good, and in fact better, than a ste-
(ARMOR) Study. May 10, 2017. www.bausch.com/our-
company/recent-news/id/2374/5102017-Wednesday. patients on systemic therapy had roid implant,” says Nathan Light-
Accessed May 16, 2017.
stable visual acuity, while those hizer, OD, an associate professor at
The Optometric Glaucoma Society with the implant saw a decline of Oklahoma College of Optometry.
recently established the Optometric roughly six letters. “This may save the patient another
Glaucoma Foundation (OGF) to support The study looked at 255 patients visit or a referral to a specialist
glaucoma education for the optometric with uveitis randomly assigned since optometrists in some states
profession, including students, residents, either a fl uocinolone intraocular can prescribe oral steroids.”
educators and practitioners. The 501(c) implant, or systemic therapy con- But Dr. Lighthizer still recom-
(3) not-for-profi t organization is designed sisting of prednisone and immuno- mends ODs consult with an
to promote excellence in the care of suppressants such as methotrexate ophthalmologist or uveitis special-
glaucoma patients, support research and or mycophenolate mofetil. While ist for some refractory cases, which
help optometrists become involved in visual acuity remained about the may lead to a team-based care
research. The OGF is led by Murray Fin- same in the two groups through approach for some patients. “It is
geret, OD, president; Leo Semes, OD, vice two years, researchers noted reacti- good to know that these special-
president; John McSoley, OD, secretary; vations of uveitis after roughly fi ve ists now may be more inclined to
and Austin Lifferth, OD, treasurer. years in the implant-treated eyes. treat with systemic therapy rather
This coincided with a decline in than surgery, and we may need to
Researchers have found that roughly visual acuity, which the researchers participate in the comanagement
15% of Ebola survivors in Sierra Leone speculate may be due to increased of these patients and potentially
who had previously reported ocular damage in the retina and choroid. follow them long-term.”
symptoms have a retinal scar that In addition to the long-term “Anytime a surgical implant into
seems unique to the disease. Re- changes in treatment effi cacy, pa- the eye can be avoided, it’s poten-
searchers now speculate the virus enters tients with the implant were more tially a good thing, especially when
the eye through the optic nerve to reach likely to experience negative ocular oral therapy in this study proved to
the retina, similarly to West Nile Virus. effects, such as cataracts, elevated preserve more vision, have fewer
intraocular pressure and glaucoma. long-term side effects and was
Steptoe PJ, Scott JT, Baxter JM, et al. Novel retinal
lesion in Ebola survivors, Sierra Leone, 2016. Emerging Patients receiving systemic therapy, more cost-effective,” Dr. Lighthizer
Infectious Diseases. 2017;23(7). [Epub ahead of print].
although they had an increased adds. “That is a win all around.”
4 REVIEW OF OPTOMETRY JUNE 15, 2017
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The leading cause of ocular discomfort
and contact lens dropout is dryness.
(cid:48)(cid:72)(cid:76)(cid:69)(cid:82)(cid:80)(cid:76)(cid:68)(cid:81)(cid:3)(cid:42)(cid:79)(cid:68)(cid:81)(cid:71)(cid:3)(cid:41)(cid:88)(cid:81)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:15)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:73)(cid:82)(cid:88)(cid:81)(cid:71)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:68)(cid:3)(cid:75)(cid:72)(cid:68)(cid:79)(cid:87)(cid:75)(cid:92)(cid:3)(cid:87)(cid:72)(cid:68)(cid:85)(cid:3)(cid:403)(cid:79)(cid:80)(cid:17)
Gland structure
captured with
Dynamic Meibomian
Imaging (DMI).
“Evaluation of meibomian glands is now
standard in my patient workups”
(cid:54)(cid:87)(cid:72)(cid:89)(cid:72)(cid:81)(cid:3)(cid:45)(cid:17)(cid:3)(cid:41)(cid:72)(cid:85)(cid:74)(cid:88)(cid:86)(cid:82)(cid:81)(cid:15)(cid:3)(cid:50)(cid:39)
(cid:39)(cid:88)(cid:81)(cid:72)(cid:86)(cid:3)(cid:40)(cid:92)(cid:72)(cid:3)(cid:38)(cid:82)(cid:81)(cid:86)(cid:88)(cid:79)(cid:87)(cid:68)(cid:81)(cid:87)(cid:86)
TM
(cid:48)(cid:46)(cid:55)(cid:16)(cid:36)(cid:39)(cid:57)(cid:3)(cid:19)(cid:20)(cid:28)(cid:3)(cid:53)(cid:72)(cid:89)(cid:3)(cid:36) (cid:87)(cid:72)(cid:68)(cid:85)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:72)(cid:17)(cid:70)(cid:82)(cid:80)(cid:3)(cid:3)(cid:696)(cid:3)(cid:3)(cid:28)(cid:20)(cid:28)(cid:16)(cid:23)(cid:24)(cid:28)(cid:16)(cid:23)(cid:27)(cid:27)(cid:19)(cid:3)(cid:3)(cid:696)(cid:3)(cid:3)(cid:86)(cid:68)(cid:79)(cid:72)(cid:86)(cid:35)(cid:87)(cid:72)(cid:68)(cid:85)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:72)(cid:17)(cid:70)(cid:82)(cid:80)
RO0217_Tear Scient.indd 1 2/2/17 11:12 AM
News Review

Bill Leaves Essential Vision Benefi ts Uncertain
The American Health Care may soon be in fl ux. benefi t for every patient younger
Act (AHCA) that passed the As it currently stands, the bill than 19.5
House on May 4 is facing provides an option for states to The legislation passed the House
criticism from patient groups such independently decide whether to after an amendment written by
as the American Medical Associa- maintain, suspend or make changes Rep. Tom MacArthur (NJ) and
tion and the American Association to the essential benefi ts previously Rep. Mark Meadows (NC) resolved
of Retired Persons for potentially protected by the Affordable Care intraparty disagreements.3 The bill
rolling back popular health care Act (ACA)—including pediatric vi- still faces Senate scrutiny and is
benefi ts.1,2 For optometry specifi - sion care.3 The change is an attempt now in limbo after a Congressional
cally, care for the youngest patients to “encourage fair health insurance Budget Offi ce report suggested 24
premiums,” ac- million could lose coverage.5
A Legislative Win in Georgia cording to the bill.3
Optometrists in Georgia can now perform certain injections, thanks When the ACA 1. Gurman A. AMA statement on cbo score of american health
care act. American Medical Association. May 24, 2017. www.
to the passage of SB 153, which was signed into law by Governor was passed in ama-assn.org/ama-statement-cbo-score-american-health-
care-act. Accessed May 30, 2017.
Nathan Deal on May 9, 2017. ODs ready to take on the scope of 2010, pediatric 2. Frank D. Health care bill endangers coverage. AARP. May
practice expansion must fi rst attend a 30-hour injectables training vision was included 24, 2017. www.aarp.org/politics-society/advocacy/info-2017/
aarp-response-cbo-score-health-care-bill-fd.html. Accsessed
program approved by the board and be under the direct supervi- as one of the 10 es- May 30, 2017.
3. MacArthur T. Amendment drafted to H.R. 1628. April 24,
sion of a board-certifi ed ophthalmologist, according to the bill. The sential benefi ts that 2017. www.politico.com/f/?id=0000015b-a790-d120-addb-
bill also includes a provision allowing optometrists to treat ocular must be covered by f7dc0ec90000. Accessed May 30, 2017.
4. American Optometric Association. AOA’s Frequently Asked
pain with non-narcotic oral analgesics, hydrocodone administered all providers.4 That Questions on the Essential Health Benefi t and Insurance Mar-
ketplaces. www.aoa.org/Documents/advocacy/FAQ_on_EHB.
orally and Schedule III or Schedule IV oral analgesics. coverage included
PDF. Accessed May 24, 2017.
a yearly eye exam 5. Congressional Budget Offi ce. American Health Care Act.
Georgia General Assembly. 017-2018 Regular Session - SB 153. www.legis.ga.gov/ www.cbo.gov/publication/52486. March 13, 2017. Accessed
Legislation/en-US/display/20172018/SB/153. Accessed June 2, 2017. with a materials May 27, 2017.
Get Ready For DEWS II
Attendees at this year’s As- eye disease, said organizer David decided whether the patient has
sociation for Research in Sullivan, PhD, in a press release.1 aqueous defi cient or evaporative
Vision and Ophthalmology While the report’s updated defi ni- dry eye, how we then tailor that
(ARVO) Annual Meeting, held in tion for dry eye—which adds a management and therapy to specifi -
Baltimore from May 6-11, were the focus on homeostasis—is a signifi - cally treat those two just simply is
fi rst to get a glimpse of The Tear cant change today, its call for better missing. We need more evidence.
Film & Ocular Surface Society’s research on treatment outcomes is We knew [dry eye treatment] was
(TFOS) forthcoming Dry Eye a welcome addition for the future, complex before, and what we re-
Workshop II (DEWS II) recommen- according to Lyndon Jones, OD, ally need is a huge number of new
dations. The full report sets out to chair of the DEWS II Management studies.” Noting that a decade has
update the defi nition, classifi cation and Therapy Subcommittee and a passed since the fi rst DEWS, Dr.
and diagnosis of dry eye, as well as professor at the Centre for Contact Jones joked that “the good thing is,
evaluate its impact, address man- Lens Research, School of Optom- we’ll be busy for the next decade.”
agement and therapy and develop etry and Vision Science, University After two years of work, DEWS
recommendations for clinical trials of Waterloo. II will be published July 1 by The
to better assess treatment options.1 “What really shocked us was Ocular Surface and will be avail-
DEWS II took two years to what little high-level evidence there able at www.tearfi lm.org, accord-
complete and involved 150 experts is to support many of the things we ing to the ARVO presentation.
from around the world, who used do or we prescribe on a day-to-day
an evidence-based approach to basis,” said Dr. Jones at the ARVO 1. Tear Film & Ocular Surface Society. www.tearfi lm.org/
dettnews-tfos_dews_ii_report_announced/101_16/eng.
increase our understanding of dry briefi ng. “And even when we have Accessed May 30, 2017.
6 REVIEW OF OPTOMETRY JUNE 15, 2017
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NNeewwss RReevviieeww

Cancer Drug Combats
Thyroid Eye Disease
BUSINESS OFFICES
11 CAMPUS BLVD., SUITE 100
NEWTOWN SQUARE, PA 19073
Adthreu gin tsaurlginet-ilnikge Photo: M CEO, INFORMMAARTCIO FNE SRERRAVRIACES GROUP
1re dreucceep tsgoyrrmo mwpttaohym fhasec latpos -r ichael Trottini, OD (2(1621)0 )2 7449-27-0160J2A1PM 7U(cid:129) EB(cid:129)MS LJ FHIHSEERHENRENNARNREE@[email protected]
sociated with thyroid
REGIONAL SALES MANAGER
eye disease, according This patient exhibits proptosis from thyroid orbitopathy. MICHELE BARRETT
to a new report.1 [phone] (cid:129) [email protected]
Teprotumumab, originally tested specifi c tissues affected by tepro- REGIONAL SALES MANAGER
as a cancer treatment, was inves- tumumab therapy. A one-year MICHAEL HOSTER
[phone] (cid:129) [email protected]
tigated in a multicenter study for follow up is currently underway
VICE PRESIDENT, OPERATIONS
its ability to reduce the severity of to determine the drug’s long-term CASEY FOSTER
thyroid-associated ophthalmopa- therapeutic effect. [phone] (cid:129) [email protected]
thy.1 Researchers randomly assigned “The results of the study are VICE PRESIDENT, CLINICAL CONTENT
87 patients, diagnosed nine months quite impressive—there is a marked PAUL M. KARPECKI, OD, FAAO
[email protected]
or less prior to the onset of symp- clinical difference in response in
PRODUCTION MANAGER
toms, to receive placebo or intra- the group receiving the active drug SCOTT TOBIN
venous teprotumumab once every compared with placebo, and the [phone] (cid:129) [email protected]
three weeks, over a 24-week period, onset of improvement was rapid,” SENIOR CIRCULATION MANAGER
or for eight injections total.1 says Tammy Than, OD, a profes- HAMILTON MAHER
[phone] (cid:129) [email protected]
The study defi ned a response as a sor at the University of Alabama at
CLASSIFIED ADVERTISING
reduction of two points on a seven- Birmingham School of Optometry. [phone]
point clinical activity score and a “FDA was impressed as well, as last
SUBSCRIPTIONS
reduction of at least two millimeters year it granted this drug ‘break- $56 A YEAR, $88 (US) IN CANADA,
in proptosis at the end of week 24.1 through therapy’ designation.” $209 (US) IN ALL OTHER COUNTRIES.
In patients who received teprotu- However, a few questions remain, SUBSCRIPTION INQUIRIES
(877) 529-1746 (US ONLY)
mumab, 69% achieved a response and Dr. Than hopes further research OUTSIDE US CALL: [phone]
vs. 20% of those who received will help uncover whether regres-
CIRCULATION
placebo at week 24, and 43% of sion of clinical improvement occurs PO BOX 81
patients in the teprotumumab group once the infusions stop. CONGERS, NY 10920
TEL: (TOLL FREE): [phone]
achieved relief of their symptoms The researchers say teprotu- OUTSIDE US: [phone]
within six weeks.1 The drug was mumab may also help patients with
also well tolerated, and the hyper- other autoimmune conditions with
glycemia some patients experienced ocular manifestations.1
CEO, INFORMATION SERVICES GROUP
was well-controlled after adjusting “Since other applications may
MARC FERRARA
the dosage.1 exist for teprotumumab in rheuma-
SENIOR VICE PRESIDENT, OPERATIONS
However, only patients recently toid arthritis and other autoimmune JEFF LEVITZ
diagnosed with active, moderate diseases, this drug may offer an
VICE PRESIDENT, HUMAN RESOURCES
to severe disease were enrolled in avenue of high impact for manag- TAMMY GARCIA
the study, so further investigation ing numerous diseases that manifest
VICE PRESIDENT, CREATIVE SERVICES & PRODUCTION
is needed to asses teprotumumab’s with debilitating ocular sequelae,” MONICA TETTAMANZI
ability to provide relief in patients Dr. Than concludes. ■ CORPORATE PRODUCTION DIRECTOR
with stable or milder forms of the JOHN ANTHONY CAGGIANO
disease. Also, orbital imaging was 1. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab VICE PRESIDENT, CIRCULATION
not performed to determine the f2o0r 1th7y;3ro7id6-(1as8s):o1c7ia4t8ed. ophthalmopathy. N Eng J Med. EMELDA BAREA
8 REVIEW OF OPTOMETRY JUNE 15, 2017
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Down, Boy.
Help Tame Postoperative Ocular Inflammation
and Pain With LOTEMAX® GEL
Indication
LOTEMAX® GEL (loteprednol etabonate ophthalmic gel) 0.5% is indicated for the treatment of
post-operative infl ammation and pain following ocular surgery.
Important Safety Information about LOTEMAX® GEL
• LOTEMAX® GEL is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the
eye and fungal diseases of ocular structures.
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual
acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
• Use of corticosteroids may result in posterior subcapsular cataract formation.
• Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation and
occurrence of perforations in those with diseases causing corneal and scleral thinning. The initial prescription
and renewal of the medication order should be made by a physician only after examination of the patient with
the aid of magnification, and where appropriate, fluorescein staining.
• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular
infection. In acute purulent conditions, steroids may mask infection or enhance existing infection.
• Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great
caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of
the eye (including herpes simplex).
• Fungal infections of the cornea are particularly prone to develop coincidentally
with long-term local steroid application. Fungus invasion must be considered
in any persistent corneal ulceration where a steroid has been used or is in use.
• Patients should not wear contact lenses when using LOTEMAX® GEL.
• The most common ocular adverse drug reactions reported were anterior
chamber inflammation (5%), eye pain (2%) and foreign body sensation (2%).
Please see brief summary of Prescribing Information on adjacent page.
®/™ are trademarks of Bausch & Lomb Incorporated or its affi liates. © 2015 Bausch & Lomb Incorporated. All rights reserved. Printed in USA. US/LGX/15/0041(1)
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BRIEF SUMMARY OF PRESCRIBING INFORMATION ossification) and teratogenic (increased incidence of meningocele, abnormal
This Brief Summary does not include all the information needed to left common carotid artery, and limb flexures) when administered orally
prescribe Lotemax Gel safely and effectively. See full prescribing to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times
information for Lotemax Gel. the maximum daily clinical dose), a dose which caused no maternal
toxicity. The no-observed-effect-level (NOEL) for these effects was
Lotemax 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment
(loteprednol etabonate ophthalmic gel) 0.5%
of rats during organogenesis resulted in teratogenicity (absent innominate
Rx only artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia
Initial Rx Approval: 1998 at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation
losses at 100 mg/kg/day and decreased fetal body weight and skeletal
INDICATIONS AND USAGE ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day
LOTEMAX is a corticosteroid indicated for the treatment of post-operative (6 times the maximum clinical dose) during organogenesis did not result
inflammation and pain following ocular surgery. in any reproductive toxicity. Loteprednol etabonate was maternally toxic
DOSAGE AND ADMINISTRATION (significantly reduced body weight gain during treatment) when administered
Invert closed bottle and shake once to fill tip before instilling drops. to pregnant rats during organogenesis at doses of ≥5 mg/kg/day.
Apply one to two drops of LOTEMAX into the conjunctival sac of the affected Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from
eye four times daily beginning the day after surgery and continuing the start of the fetal period through the end of lactation, a maternally toxic
throughout the first 2 weeks of the post-operative period. treatment regimen (significantly decreased body weight gain), gave rise to
decreased growth and survival, and retarded development in the offspring
CONTRAINDICATIONS
during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol
LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in
etabonate had no effect on the duration of gestation or parturition when
most viral diseases of the cornea and conjunctiva including epithelial herpes
administered orally to pregnant rats at doses up to 50 mg/kg/day during the
simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in
fetal period.
mycobacterial infection of the eye and fungal diseases of ocular structures.
There are no adequate and well controlled studies in pregnant women.
WARNINGS AND PRECAUTIONS
LOTEMAX should be used during pregnancy only if the potential benefit
Intraocular Pressure (IOP) Increase justifies the potential risk to the fetus.
Prolonged use of corticosteroids may result in glaucoma with damage to the Nursing Mothers
optic nerve, defects in visual acuity and fields of vision. Steroids should be
It is not known whether topical ophthalmic administration of corticosteroids
used with caution in the presence of glaucoma. If this product is used for 10
could result in sufficient systemic absorption to produce detectable quantities
days or longer, intraocular pressure should be monitored.
in human milk. Systemic steroids appear in human milk and could suppress
Cataracts growth, interfere with endogenous corticosteroid production, or cause other
Use of corticosteroids may result in posterior subcapsular cataract formation. untoward effects. Caution should be exercised when LOTEMAX is administered
to a nursing woman.
Delayed Healing
Pediatric Use
The use of steroids after cataract surgery may delay healing and increase the
incidence of bleb formation. In those diseases causing thinning of the cornea Safety and effectiveness in pediatric patients have not been established.
or sclera, perforations have been known to occur with the use of topical Geriatric Use
steroids. The initial prescription and renewal of the medication order should
No overall differences in safety and effectiveness have been observed
be made by a physician only after examination of the patient with the aid
between elderly and younger patients.
of magnification such as slit lamp biomicroscopy and, where appropriate,
NONCLINICAL TOXICOLOGY
fluorescein staining.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Bacterial Infections
Long-term animal studies have not been conducted to evaluate the
Prolonged use of corticosteroids may suppress the host response and
carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was
thus increase the hazard of secondary ocular infections. In acute purulent
not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in
conditions of the eye, steroids may mask infection or enhance existing
a chromosome aberration test in human lymphocytes, or in vivo in the single
infection.
dose mouse micronucleus assay. Treatment of male and female rats with up
Viral Infections
to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively,
Employment of a corticosteroid medication in the treatment of patients with (600 and 300 times the maximum clinical dose, respectively) prior to and
a history of herpes simplex requires great caution. Use of ocular steroids may during mating did not impair fertility in either gender.
prolong the course and may exacerbate the severity of many viral infections
PATIENT COUNSELING INFORMATION
of the eye (including herpes simplex).
Administration
Fungal Infections
Invert closed bottle and shake once to fill tip before instilling drops.
Fungal infections of the cornea are particularly prone to develop
Risk of Contamination
coincidentally with long-term local steroid application. Fungus invasion must
be considered in any persistent corneal ulceration where a steroid has been Patients should be advised not to allow the dropper tip to touch any surface,
used or is in use. Fungal cultures should be taken when appropriate. as this may contaminate the gel.
Contact Lens Wear Contact Lens Wear
Patients should not wear contact lenses during their course of therapy with Patients should be advised not to wear contact lenses when using LOTEMAX.
LOTEMAX. Risk of Secondary Infection
ADVERSE REACTIONS If pain develops, redness, itching or inflammation becomes aggravated, the
Adverse reactions associated with ophthalmic steroids include elevated patient should be advised to consult a physician.
intraocular pressure, which may be associated with infrequent optic nerve
damage, visual acuity and field defects, posterior subcapsular cataract Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC
formation, delayed wound healing and secondary ocular infection from Bridgewater, NJ 08807 USA
pathogens including herpes simplex, and perforation of the globe where
US Patent No. 5,800,807
there is thinning of the cornea or sclera.
©Bausch & Lomb Incorporated
The most common adverse drug reactions reported were anterior chamber
Lotemax is a registered trademark of Bausch & Lomb Incorporated or its affiliates.
inflammation (5%), eye pain (2%), and foreign body sensation (2%).
USE IN SPECIFIC POPULATIONS
LGX.0114.USA.16
Pregnancy
Based on 9269101/9269201 Revised: 08/2016
Teratogenic Effects
Loteprednol etabonate has been shown to be embryotoxic (delayed
RRPP00551177__BBLL LLootteemmaaxx PPII..iinndddd 11 44//1133//1177 1111::2200 AAMM