Download LUCENTIS® Is the First Biologic FDA-Approved for the

LUCENTIS® Is the First Biologic FDA-Approved for the Treatment of wAMD,
Macular Edema Following RVO (RVO), and DME
LUCENTIS was specifically designed for use in the eye, and rapid systemic clearance to minimize potential systemic exposure while
simultaneously inhibiting intraocular VEGF-A.1,2 The clinical significance of the molecular design of LUCENTIS is not known.1
DISEASE STATE OVERVIEW
•W
et age-related macular degeneration (wAMD) is a
retinal disease that can cause severe and irreversible
vision loss.3
• It is a leading cause of blindness in Americans age 60
and over.3
• Retinal vein occlusions (RVOs)
are the second most common type
of retinal vascular disease and
include:4
– Branch RVO (BRVO)
– Central RVO (CRVO)
• Mean age at onset is 65 years.5
• RVO risk factors include
hypertension, diabetes mellitus,
arteriosclerosis, and open-angle
glaucoma.6
• Diabetic macular edema (DME) is a
complication of diabetes mellitus, which is
the leading cause of new cases of blindness
in adults (ages 20-74 years) in the U.S.7
•R
etinopathies like DME are the most
frequent microvascular complication of
diabetes mellitus.8
•U
p to 10% of people with diabetes,
or approximately 500,000 Americans,
will develop DME during their lifetime.9
•M
any patients remain undiagnosed
and untreated.10
INDICATIONS AND DOSING
LUCENTIS is indicated for the treatment of patients with:1
Neovascular (wet) age-related macular degeneration
Macular edema following retinal
(wAMD):
vein occlusion (RVO):
•L
UCENTIS 0.5 mg (0.05 mL) is recommended to be
•L
UCENTIS 0.5 mg (0.05 mL)
administered by intravitreal injection once a month
(approximately 28 days).
•A
lthough not as effective, patients may be treated with three
monthly doses followed by less frequent dosing with regular
assessment. In the nine months after three monthly doses,
less frequent dosing with 4-5 doses on average is expected
to maintain visual acuity while monthly dosing may be
expected to result in an additional average 1-2 letter gain.
should be administered by
intravitreal injection once a month
(approximately 28 days).
Diabetic macular edema
(DME):
•L
UCENTIS 0.3 mg (0.05 mL) is
recommended to be administered by
intravitreal injection once a month
(approximately 28 days).
PRODUCT EFFICACY
LUCENTIS demonstrated clinically meaningful results in wAMD, RVO, and DME.
•w
AMD: In MARINA, 30% of patients treated with
•
•
•
•
•
monthly LUCENTIS gained ≥15 letters at 2 years
compared with 4% of sham-treated patients.1
In ANCHOR, 37% of patients treated with monthly
LUCENTIS gained ≥15 letters at 2 years compared with
9% of verteporfin PDT-treated patients.1
10% of treated patients in MARINA experienced a
loss ≥15 letters vs. 47% of sham-treated patients,
respectively.1
In HARBOR, patients on a less-frequent dosing regimen
received an average of 7.7 injections in 12 months
resulting in a gain of 8.2 letters, compared to 10.1
letters with 11.3 injections in monthly dosed patients.1,11
In HARBOR, for patients in the less-frequent dosing arm,
who were given given 3 initial monthly injections and
completed 12 months of the study, 86% did not receive
monthly injections.1,14
Patients were assessed regularly.1
•R
VO: In BRAVO, 61% of patients
treated with monthly LUCENTIS
gained ≥15 letters at month 6
compared with 29% of shamtreated patients.1
• In CRUISE, 48% of patients
treated with monthly LUCENTIS
gained ≥15 letters at month 6
compared with 17% of shamtreated patients.1
• In both BRAVO and CRUISE,
treatment with monthly
LUCENTIS resulted in rapid
increases in mean visual acuity
observed as early as 7 days
following the initial dose.12,13
• DME: In RIDE and RISE, 39% of patients
receiving monthly 0.3 mg LUCENTIS
gained ≥15 letters at 24 months
compared with 15% of sham-treated*
patients.1
•L
UCENTIS demonstrated rapid and
significant vision improvements at day
7 (+ 4.4 letters) that continued through
year 3 (+12.4 letters).15
•L
UCENTIS improved or maintained 57.2%
of patients’ vision to at least 20/40 at
month 24 compared with 36.3% of
sham-treated patients.15
* 72% of sham-treated patients received protocol-specified laser treatment
vs. 38% of LUCENTIS-treated patients.
CONTRAINDICATIONS
LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.
For additional safety information, please see reverse and accompanying LUCENTIS full prescribing information.
CLINICAL EXPERIENCE
Genentech is committed to ophthalmology and the continued study of LUCENTIS.
The ocular and systemic safety profile of LUCENTIS have been studied in wAMD, RVO, and DME.1
• wAMD: LUCENTIS was FDA approved
in 2006 to treat wet AMD based on 3
pivotal trials.
• LUCENTIS has been studied in wet AMD
for more than a decade in 11 clinical trials
and offers 7 years of physician and patient
experience.1,14
•R
VO: LUCENTIS was FDA approved in
•D
ME: LUCENTIS was FDA approved in
•7
89 trial patients with macular edema
•P
atients were followed for 3 years.
•P
rimary endpoints in both clinical trials
2010 to treat macular edema following
RVO based on 6-month data from 2
clinical trials.
following RVO were studied.
2012 to treat DME based on 2 pivotal
trials with a total of 759 trial patients.
were measured at 2 years.
•P
atients were followed for 1 year.
• More than 5,500 wet AMD patients have
participated in U.S. clinical trials alone.14
NDC AND PRICING
NDC* and Wholesale Acquisition Cost (WAC)†
HOW SUPPLIED
NDC
WAC
Each LUCENTIS 0.5 mg carton contains a single-use, 2-cc glass vial with a BLUE CAP
50242-0080-01
$1,950
Each LUCENTIS 0.3 mg carton contains a single-use, 2-cc glass vial with a WHITE CAP
50242-0082-01
$1,170
*National Drug Code
†
Pricing information is current as of October 2012.
STORAGE AND HANDLING
LUCENTIS should be refrigerated at 2°− 8ºC (36°− 46ºF). DO NOT FREEZE. Do not use beyond the date stamped on the label. LUCENTIS vials
should be protected from light. Store in the original carton until time of use.
IMPORTANT SAFETY INFORMATION
LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.
WARNINGS AND PRECAUTIONS
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic
cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored during the week
following the injection to permit early treatment, should an infection occur.
Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. IOP and perfusion of
the optic nerve head should be monitored and managed appropriately.
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs
following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths
of unknown cause).
Fatal events occurred more frequently in DME patients treated monthly with LUCENTIS compared with control. Although the rate of fatal events
was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and
intravitreal use of VEGF inhibitors cannot be excluded.
ADVERSE EVENTS
Serious adverse events related to the injection procedure that occurred in < 0.1% of intravitreal injections included endophthalmitis, rhegmatogenous
retinal detachment, and iatrogenic traumatic cataract.
In the LUCENTIS Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and
increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, headache, influenza, sinusitis, cough, and nausea.
For additional safety information, please see LUCENTIS full prescribing information.
References: 1. LUCENTIS® (ranibizumab injection) full prescribing information. Genentech, Inc, February 2013. 2. Ferrara N, et al. Retina. 2006;26:859-870. 3. National Eye
Institute. Facts About Age-Related Macular Degeneration. http://www.nei.nih.gov/health/maculardegen/armd_facts.asp#. Accessed January 25, 2013. 4. Rehak J, Rehak M. Curr
Eye Res. 2008;33:111-131. 5. Fegan CD. Eye. 2002;16:98-106. 6. Glacet-Bernard A, et al. Ophthalmology. 1996;103:551-560. 7. Centers for Disease Control and Prevention.
National Diabetes Fact Sheet, 2011. http://apps.nccd.cdc.gov/DDTSTRS/FactSheet.aspx. Accessed January 25, 2013. 8. Abbate M, et al. Curr Diabetes Rev. 2011;7(3):190-200.
9. Ali FA. Digital Journal of Ophthalmology. 1997;3(6). www.djo.harvard.edu/site.php?url=/physicians/oa/387. Accessed January 25, 2013. 10. Soliman AZ, et al. Program 1287/
A37 [program abstract]. Presented at the 2011 Association for Vision and Research Annual Meeting: May 2, 2011. 11. Busbee BG, et al. [published online ahead of print January
24 2013]. Ophthalmology. doi:10.1016/j.ophtha.2012.10.014. 12. Campochiaro PA, Heier JS, Feiner L, et al; for BRAVO Study Group. Ophthalmology. 2010;117:1102-1112.
13. Brown DM, et al. Ophthalmology. 2010;117(6):1124-1133. 14. Data on file. Genentech, Inc. 15. Food and Drug Administration. Dermatologic and Ophthalmic Drugs Advisory
Committee meeting briefing package for sBLA 125156 LUCENTIS (ranibizumab injection). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM313089.pdf. Accessed January 28, 2013.
©2013 Genentech, Inc., So. San Francisco, CA LUC0001259301 2/13