Also Inside: - Review of Ophthalmology

136 Pages·2013·19.86 MB·English

DRY-EYE TESTS: READING IS FUNDAMENTAL P. 110 • WILLS RESIDENT CASE SERIES P. 129
WHAT DOES IN-CLINIC IOP REALLY TELL US? P. 104 • RECOGNIZE & TREAT THYROID EYE DISEASE P. 98
DRY AMD: PROTECTING THE RPE P. 92 • REFRACTIVE SURGERY: RETHINKING WHAT’S ‘BORDERLINE’ P. 114
R
e
v
ie
w
o
f O
p
h
th
a
lm
o
lo
g
y
V
o
l. X
X
, N
o November 2013 • revophth.com
. 1
1
•
N
o
v
e
m
b
e
r
2
0
1
3
•
F
u
tu
r
e
T
r
e
n
d
s
•
M
a
x
im
iz
in
g
E
ffi c
ie
n
c
y
•
T
h
e
F
D
A
S
tr
u
g
g
le
s
fo
r
R
e
d
e
m
p
tio
n
•
T
hy Navigating the Perfect Storm P. 26 Code Explosion: Understanding ICD-10 P. 60
r
o
id
E Time to Tap Alternative Income Streams P. 42 When Your EHR’s a Lemon P. 48
y
e
D
Ophthalmology’s Brave New World P. 66
is
e
a
s
e
Also Inside:
The FDA’s Struggle for Redemption P. 80
fc_rp1013.indd 1 10/24/13 2:19 PM
WHITESTAR SIGNATURE® SYSTEM WITH
FUSION® PHACO TECHNOLOGY
FUSION® Pump ELLIPS® FX Handpiece
Fluidics Management Ultrasound Energy Management
Proven peristaltic pump provides Advanced venturi pump provides ELLIPS® FX Handpiece delivers
excellent holdability outstanding followability smooth cutting and excellent efficiency
Experience FUSION® PHACO Technology. 1-877-AMO-4-LIFE • www.WHITESTARSignature.com
The WHITESTAR Signature® System incorporating FUSION® Fluidics is a modular ophthalmic microsurgical system that facilitates anterior
segment (cataract) surgery. Risks and complications may include broken ocular capsule or corneal burn. All personnel who might operate this
equipment must read and understand the instructions in this manual before the system is used. This device is only to be used by a trained
licensed physician. Please refer to the WHITESTAR Signature® System Operator’s Manual for complete Important Safety Information.
Caution: Federal law restricts this device to sale by or on the order of a physician.
WHITESTAR Signature, FUSION, and ELLIPS are trademarks owned by or licensed to Abbott Laboratories, it subsidiaries or affiliates.
© 2013 Abbott Medical Optics Inc. www.AbbottMedicalOptics.com 2013.04.03-CT6738
RP0713_Abbott.indd 1 6/12/13 3:32 PM
WNEWS
E
I
V
E
R
Volume XX • No. 11 • November 2013
Cataract Surgeries on the Rise,
Raising Access & Cost Issues
As baby boomers enter their retirement Despite the common nature of worldwide where researchers can
years, health-care costs for complex cataracts, the United States has examine medical data on virtually
and debilitating conditions such as little current population-based data everyone to see how often condi-
Alzheimer’s disease are expected to on cataract surgery, information that tions strike and whether treatments
soar. Not drawing as much attention can help estimate demand. For the succeed.
is the likelihood of similarly rising Mayo study, researchers mined the The research found:
expenses for common age-related National Institutes of Health-fund- • Cataract surgery has increased
medical procedures. A Mayo Clinic ed Rochester Epidemiology Proj- steadily, peaking in 2011 at a rate of
study looked at one of those—cata- ect to identify cataract surgeries in 1,100 per 100,000 people.
ract surgery—and found that more Olmsted County, Minn., from 2005 • Sixty percent of people receiv-
people are getting the procedure, to 2011. The project, a partnership ing cataract surgery on one eye re-
seeking it at younger ages and hav- of Mayo Clinic, Olmsted Medical turned within three months to have
ing both eyes repaired within a few Center and other health providers, it performed on the second eye, a
months, rather than only treating makes the county one of few places signifi cant increase over the number
one eye. The demand shows no sign
TFOS Seeks Formal Defi nition of Contact Lens Discomfort
of leveling off, raising the need to
manage costs and ensure access to
Contact lens discomfort may be the leading cause of patient dissatisfaction with, and
appropriate cataract treatment, the
discontinuation of, contact lens wear throughout the world—but there is little agreement
researchers say. The fi ndings were
among vision researchers and eye-care professionals about how to defi ne and manage its
published in the Journal of Cataract
causes.
& Refractive Surgery.
“Up to half of all contact lens wearers experience contact lens discomfort,” said Jason
“Cataract surgery rates are rising J. Nichols, OD, MPH, PhD, professor at the University of Houston College of Optometry.
in all age groups between 50 and 90, “However, there is no global consensus concerning the defi nition, classifi cation, epidemiol-
but the greatest increase is in the ogy, pathophysiology, diagnosis, management and the proper design of clinical studies for
70- and 80-year-olds. And part of CLD.”
that is that our older population, or To lay the groundwork for defi ning and treating this widespread issue, the Tear Film
& Ocular Surface Society organized the TFOS International Workshop on Contact Lens
the aging baby boomers, are working
Discomfort, which was chaired by Dr. Nichols. The fi ndings were reported in Investigative
longer, they want to be more active,
Ophthalmology & Visual Science.
they have more demands on their
The CLD Workshop took 18 months to complete and involved 79 experts from around
vision,” says senior author Jay Erie,
the world. “Workshop participants used an evidence-based approach and a process of
MD, a Mayo Clinic ophthalmolo- open communication, dialogue and transparency in order to achieve a global consen-
gist. “That’s why they’re looking for sus concerning multiple aspects of CLD,” said Mark Willcox, PhD, FBCLA, FAAO, MASM,
surgery sooner — so that they can professor at the School of Optometry & Vision Science, University of New South Wales, and
remain independent, remain active, vice-chair of the workshop.
continue to work.” “This TFOS report will signifi cantly increase awareness of factors that may, and may
not, contribute to the generation of CLD. Ideally, this TFOS report will stimulate innovative
In the United States, age-related
research in this very important fi eld,” added David A. Sullivan, MS, PhD, FARVO, senior
cataracts affect at least 22 million peo-
scientist at the Schepens Eye Research Institute/Harvard Medical School and Organizer of
ple and cost an estimated $6.8 billion
the TFOS CLD Workshop.
to treat each year; the cataract case
The workshop report is freely available to scientists and clinicians worldwide (tearfi lm.
load is expected to rise to 30 million org).
people by 2020, the researchers noted.
November 2013 | Revophth.com | 3
003_rp1113_news.indd 3 10/23/13 2:36 PM
Really?
Who has the experience to get you through
Meaningful Use Stage 2?
EHR Ophthalmology Optometry Total Attestations1
Medflow
1200 671 1871
The
EHR Total Attestations2
Numbers MDoffice 255
EyeMD EMR Healthcare Systems 194
Speak For
MDIntelleSys 115
Themselves.
NexTech 61
Register for our next Meaningful Use Stage 2 Webinar:
December 12 at 12:00 pm EST
The Medflow complete EHR is 2014 Edition compliant and has been certified by an ONC-ACB in accordance
with the applicable certification criteria adopted by the Secretary of the U.S. Department of Health and Human
Services. This certification does not represent an endorsement by the U.S. Department of Health and Human
Services or guarantee the receipt of incentive payments.                                                                  
Medflow EHR version 8.1 
Certified 8/29/13, Version 8.1, Criteria Certified: 170.314(a)(1‐15); 170.314(b)(1‐5, 7); 170.314(c)(1‐3); 170.314(d)
(1‐8); 170.314(e)(1‐3); 170.314(f)(1‐3); 170.314(g)(2‐4) Clinical Quality Measures tested: CMS050v2; CMS062v2;
CMS068v3; CMS069v2; CMS122v2; CMS127v2; CMS131v2; CMS132v2; CMS133v2; CMS138v2; CMS142v2;
CMS143v2; CMS147v2; CMS156v2; CMS165v2; CMS167v2  Additional software used: NewCropRX, MS Excel,
DataMotion, LDM Group
Price Transparency
Licensing and implementation of the functionality and content covered by this certification will require
ongoing and/or one-time license and/or service fees covering the right to use the in-scope solutions,
support, and requested standard implementation, integration, and consulting services.  Required
connectivity for transmitting patient data will require one-time costs, ongoing service fees, and/or
transaction-based fees.
Source: cms.gov through July 2013 CMS recorded as of September 2, 2013
http://www.healthit.gov/sites/default/files/mu_report.csv
1Medflow numbers include Medflow/Allscripts™ Doctors
2Ophthalmology and Optometry
RP1113_Medflow.indd 1 10/16/13 9:58 AM
W News
E
I
V
E
R
in a previous Mayo study, which cov-
ered 1998 to 2004.
• The mean annual rate of cataract
surgery for women was signifi cantly Phillips* Crosshair Axis Marker
higher than for men.
• There were signifi cant increases
in cataract surgery over the past 32
years among people in all age groups,
except those 90 and older.
The trend raises questions about
treatment costs and the resources
needed to meet demand, Dr. Erie
says. Medicare, for example, typi-
cally covers cataract surgery for its
patients; in general, cataract surgery
on a Medicare patient costs roughly
$3,000 per eye.
“Ophthalmology and ophthalmol-
obgeigsitnsn ainngd tpoa ltoieonkt sa ta nwda yps atyheerys caarne (cid:35)(cid:82)(cid:79)(cid:83)(cid:83)(cid:72)(cid:65)(cid:73)(cid:82)(cid:0)(cid:33)(cid:76)(cid:73)(cid:71)(cid:78)(cid:77) (cid:69) (cid:78) (cid:84)
wdsmmsoaievaiycziixsigede.i hm utyt ahit zlhae esep caatvot hiiwsseetuhn atotool l ua ebtgs,ec oaaoncinnmeiedsfiet t ty h s.t”o aht wneoDd wctr h.o emesE t ci inrantiinoe-- 0 8-16160-C: Phillips Cr(cid:34)o(cid:76)s(cid:65)s(cid:68)h(cid:69)ai(cid:83)r(cid:0) (cid:55)Gr(cid:73)a(cid:84)v(cid:72)it(cid:0)y(cid:53) M(cid:78)a(cid:73)qrk(cid:85)e(cid:69)r (cid:0)(cid:35)(cid:82)(cid:79)(cid:83)(cid:83)(cid:72)(cid:65)(cid:73)(cid:82)
(cid:71)(cid:0)
(cid:78)
New Test Could (cid:75)(cid:73)
(cid:82)
(cid:65)
(cid:45)
Diagnose RP (cid:76)(cid:0)
(cid:65)
(cid:84)
(cid:83)
A new Duke University study says it can (cid:73)(cid:36)
link what is in a patient’s urine to
gene mutations that cause retinitis
pigmentosa. The fi ndings appear on- (cid:115)(cid:0) (cid:39)(cid:82)(cid:65)(cid:86)(cid:73)(cid:84)(cid:89)(cid:0)(cid:55)(cid:69)(cid:73)(cid:71)(cid:72)(cid:84)(cid:69)(cid:68)(cid:0)(cid:38)(cid:79)(cid:82)(cid:0)(cid:33)(cid:67)(cid:67)(cid:85)(cid:82)(cid:65)(cid:84)(cid:69)(cid:0)(cid:48)(cid:76)(cid:65)(cid:67)(cid:69)(cid:77)(cid:69)(cid:78)(cid:84)(cid:0)(cid:55)(cid:72)(cid:69)(cid:78)(cid:0)(cid:48)(cid:65)(cid:84)(cid:73)(cid:69)(cid:78)(cid:84)(cid:0)(cid:41)(cid:83)(cid:0)
(cid:0) (cid:41)(cid:78)(cid:0)(cid:52)(cid:72)(cid:69)(cid:0)(cid:53)(cid:80)(cid:82)(cid:73)(cid:71)(cid:72)(cid:84)(cid:0)(cid:48)(cid:79)(cid:83)(cid:73)(cid:84)(cid:73)(cid:79)(cid:78)(cid:14)
line in the Journal of Lipid Research.
(cid:0)
“My collaborators, Rong Wen,
(cid:115)(cid:0) (cid:33)(cid:88)(cid:73)(cid:83)(cid:0)(cid:45)(cid:65)(cid:82)(cid:75)(cid:83)(cid:0)(cid:47)(cid:78)(cid:0)(cid:34)(cid:69)(cid:86)(cid:69)(cid:76)(cid:0)(cid:52)(cid:79)(cid:0)(cid:45)(cid:65)(cid:78)(cid:85)(cid:65)(cid:76)(cid:76)(cid:89)(cid:0)(cid:51)(cid:69)(cid:84)(cid:0)(cid:52)(cid:79)(cid:0)(cid:36)(cid:69)(cid:83)(cid:73)(cid:82)(cid:69)(cid:68)(cid:0)(cid:33)(cid:88)(cid:73)(cid:83)(cid:14)
MD, PhD, and Byron Lam, MD, at (cid:0)
the Bascom Palmer Eye Institute in (cid:115)(cid:0) (cid:35)(cid:82)(cid:79)(cid:83)(cid:83)(cid:72)(cid:65)(cid:73)(cid:82)(cid:0)(cid:38)(cid:85)(cid:78)(cid:67)(cid:84)(cid:73)(cid:79)(cid:78)(cid:0)(cid:33)(cid:76)(cid:76)(cid:79)(cid:87)(cid:83)(cid:0)(cid:51)(cid:85)(cid:82)(cid:71)(cid:69)(cid:79)(cid:78)(cid:0)(cid:52)(cid:79)(cid:0)(cid:33)(cid:76)(cid:73)(cid:71)(cid:78)(cid:0)(cid:45)(cid:65)(cid:82)(cid:75)(cid:83)(cid:0)(cid:36)(cid:73)(cid:82)(cid:69)(cid:67)(cid:84)(cid:76)(cid:89)(cid:0)
Florida fi rst sought my expertise in (cid:0) (cid:55)(cid:72)(cid:73)(cid:76)(cid:69)(cid:0)(cid:54)(cid:73)(cid:69)(cid:87)(cid:73)(cid:78)(cid:71)(cid:0)(cid:52)(cid:79)(cid:80)(cid:79)(cid:71)(cid:82)(cid:65)(cid:80)(cid:72)(cid:89)(cid:12)(cid:0)(cid:33)(cid:76)(cid:76)(cid:79)(cid:87)(cid:73)(cid:78)(cid:71)(cid:0)(cid:38)(cid:79)(cid:82)(cid:0)(cid:33)(cid:0)(cid:51)(cid:65)(cid:70)(cid:69)(cid:84)(cid:89)(cid:0)(cid:35)(cid:72)(cid:69)(cid:67)(cid:75)(cid:0)
(cid:0) (cid:33)(cid:78)(cid:68)(cid:0)(cid:38)(cid:73)(cid:78)(cid:69)(cid:82)(cid:0)(cid:50)(cid:69)(cid:70)(cid:73)(cid:78)(cid:69)(cid:77)(cid:69)(cid:78)(cid:84)(cid:0)(cid:47)(cid:70)(cid:0)(cid:33)(cid:88)(cid:73)(cid:83)(cid:0)(cid:34)(cid:69)(cid:70)(cid:79)(cid:82)(cid:69)(cid:0)(cid:45)(cid:65)(cid:82)(cid:75)(cid:73)(cid:78)(cid:71)(cid:14)
mass spectrometry to analyze cells
(cid:0)
cultured from a family in which
(cid:115)(cid:0) (cid:50)(cid:69)(cid:85)(cid:83)(cid:65)(cid:66)(cid:76)(cid:69)(cid:12)(cid:0)(cid:33)(cid:85)(cid:84)(cid:79)(cid:67)(cid:76)(cid:65)(cid:86)(cid:65)(cid:66)(cid:76)(cid:69)(cid:12)(cid:0)(cid:45)(cid:65)(cid:68)(cid:69)(cid:0)(cid:41)(cid:78)(cid:0)(cid:52)(cid:72)(cid:69)(cid:0)(cid:53)(cid:51)(cid:33)(cid:12)(cid:0)(cid:39)(cid:85)(cid:65)(cid:82)(cid:65)(cid:78)(cid:84)(cid:69)(cid:69)(cid:68)(cid:0)(cid:38)(cid:79)(cid:82)(cid:0)(cid:0)
three out of the four siblings suffer (cid:0) (cid:44)(cid:73)(cid:70)(cid:69)(cid:12)(cid:0)(cid:33)(cid:78)(cid:68)(cid:0)(cid:33)(cid:86)(cid:65)(cid:73)(cid:76)(cid:65)(cid:66)(cid:76)(cid:69)(cid:0)(cid:38)(cid:79)(cid:82)(cid:0)(cid:33)(cid:0)(cid:19)(cid:16)(cid:13)(cid:36)(cid:65)(cid:89)(cid:0)(cid:51)(cid:85)(cid:82)(cid:71)(cid:73)(cid:67)(cid:65)(cid:76)(cid:0)(cid:37)(cid:86)(cid:65)(cid:76)(cid:85)(cid:65)(cid:84)(cid:73)(cid:79)(cid:78)(cid:0)(cid:55)(cid:73)(cid:84)(cid:72)(cid:79)(cid:85)(cid:84)(cid:0)
from RP,” said Ziqiang Guan, PhD, (cid:0) (cid:47)(cid:66)(cid:76)(cid:73)(cid:71)(cid:65)(cid:84)(cid:73)(cid:79)(cid:78)(cid:14)
an associate research professor of
(cid:35)(cid:79)(cid:78)(cid:84)(cid:65)(cid:67)(cid:84)(cid:0)(cid:50)(cid:72)(cid:69)(cid:73)(cid:78)(cid:0)(cid:45)(cid:69)(cid:68)(cid:73)(cid:67)(cid:65)(cid:76)(cid:0)(cid:65)(cid:84)(cid:0)(cid:23)(cid:18)(cid:23)(cid:13)(cid:18)(cid:16)(cid:25)(cid:13)(cid:18)(cid:18)(cid:20)(cid:20)(cid:0)
biochemistry in the Duke University
(cid:38)(cid:79)(cid:82)(cid:0)(cid:45)(cid:79)(cid:82)(cid:69)(cid:0)(cid:41)(cid:78)(cid:70)(cid:79)(cid:82)(cid:77)(cid:65)(cid:84)(cid:73)(cid:79)(cid:78)(cid:14)
Medical School and a contributing
author of the study.
Dr. Guan’s collaborators had pre-
viously sequenced the genome of
3360 Scherer Drive, Suite B, St. Petersburg, FL 33716
(cid:24)(cid:16)(cid:16)(cid:13)(cid:22)(cid:19)(cid:23)(cid:13)(cid:20)(cid:19)(cid:20)(cid:22)(cid:0)(cid:115)(cid:0)(cid:52)(cid:69)(cid:76)(cid:26)(cid:0)(cid:23)(cid:18)(cid:23)(cid:13)(cid:18)(cid:16)(cid:25)(cid:13)(cid:18)(cid:18)(cid:20)(cid:20)(cid:0)(cid:115)(cid:0)(cid:38)(cid:65)(cid:88)(cid:26)(cid:0)(cid:23)(cid:18)(cid:23)(cid:13)(cid:19)(cid:20)(cid:17)(cid:13)(cid:24)(cid:17)(cid:18)(cid:19)(cid:0)(cid:0)
(continued on page 7) (cid:37)(cid:77)(cid:65)(cid:73)(cid:76)(cid:26)(cid:0)(cid:41)(cid:78)(cid:70)(cid:79)(cid:32)(cid:50)(cid:72)(cid:69)(cid:73)(cid:78)(cid:45)(cid:69)(cid:68)(cid:73)(cid:67)(cid:65)(cid:76)(cid:14)(cid:67)(cid:79)(cid:77)(cid:0)(cid:115)(cid:0)(cid:55)(cid:69)(cid:66)(cid:83)(cid:73)(cid:84)(cid:69)(cid:26)(cid:0)(cid:87)(cid:87)(cid:87)(cid:14)(cid:50)(cid:72)(cid:69)(cid:73)(cid:78)(cid:45)(cid:69)(cid:68)(cid:73)(cid:67)(cid:65)(cid:76)(cid:14)(cid:67)(cid:79)(cid:77)
(cid:10)(cid:36)(cid:69)(cid:86)(cid:69)(cid:76)(cid:79)(cid:80)(cid:69)(cid:68)(cid:0)(cid:41)(cid:78)(cid:0)(cid:35)(cid:79)(cid:79)(cid:82)(cid:68)(cid:73)(cid:78)(cid:65)(cid:84)(cid:73)(cid:79)(cid:78)(cid:0)(cid:55)(cid:73)(cid:84)(cid:72)(cid:0)(cid:33)(cid:78)(cid:68)(cid:82)(cid:69)(cid:87)(cid:0)(cid:38)(cid:14)(cid:0)(cid:48)(cid:72)(cid:73)(cid:76)(cid:76)(cid:73)(cid:80)(cid:83)(cid:12)(cid:0)(cid:45)(cid:14)(cid:36)(cid:14)
(cid:45)(cid:73)(cid:67)(cid:72)(cid:65)(cid:69)(cid:76)(cid:65)(cid:78)(cid:71)(cid:69)(cid:76)(cid:79)(cid:12)(cid:0)(cid:44)(cid:65)(cid:77)(cid:69)(cid:78)(cid:84)(cid:65)(cid:84)(cid:73)(cid:79)(cid:78)
1342 Rev.A AHBC
003_rp1113_news.indd 5 10/23/13 2:36 PM
W
E Ophthalmic Product Development Insights
I
V
E
R Matthew Chapin, Brian Campion, Susan Benton, Van Sandwick • Ora Inc., Andover, Mass.
In our previous three columns, we’ve patent, which claims the compound/biologic invention has been described in its entirety in
discussed the steps of establishing a Target or device itself; 2) Method of Use patent, a single publicly accessible prior art reference
Product Profi le; when and how to coordinate which covers the use of compound/biologic before the fi ling date of the relevant patent
meeting with the Food and Drug Administra- or class of the same to treat a disease; 3) application. Non-obviousness, on the other
tion; and developing a business plan in order Formulation patent, which covers the phar- hand, is a much more complex test that can
to secure funding. In this column, we will maceutical dosage form; and 4) Manufactur- be thought of as the next hurdle following a
discuss considerations surrounding intel- ing patent, which covers the manufacturing fi nding of novelty. An invention is deemed to
lectual property, or IP, within the context of process. Many view composition of matter be obvious by the United States Patent and
establishing and protecting market share for and device patents as the preferred type Trademark Offi ce if all of the various portions
the target product. of patent and it is usually the fi rst type of of the invention are described or suggested
patent fi led for a product. However, it should in two or more prior art references. Note
Protection Strategies be strongly noted that one can easily cre- that while simplifi ed here, application of the
Beginning with the end in mind, one must ate market share by leveraging the other obviousness standard can be very complex.
take care to consider 1) how the target types of patents, which can extend patent With the basics of the standards of patentabil-
product market share will be protected and protection beyond the life of a soon-to-expire ity in mind, one can get a basic lay of the land,
2) whether there is third-party IP that would composition of matter or device patent. In so to speak, by conducting a fi rst-pass prior
block the intended manufacture, use, distribu- the context of drug rescue or drug repurpos- art or patentability search on PubMed and the
tion or sale of the target product in the target ing, new method of use patents can some- USPTO website (or Google under the patents
market. Provided that the target product is times open the door to exclusivity for using subsection). Sound IP protection will be key in
well-differentiated by its performance (e.g., a known compound for treating a different the efforts to raise funds from venture capital
effi cacy and safety) when compared to disease. This is often seen with ophthalmic or otherwise convince potential partners to
substitute products, the most often considered therapeutics that are repurposed actives into invest time and money in commercializing the
way to achieve market share or exclusivity new topical or locally delivered products, target product.
is through the limited monopoly provided by Depending on the parameters of your
a granted patent. While outside the scope of patentability search, one will probably need a
this column, it should also be noted that freedom to operate search.
several layers and/or combinations
of IP strategies exist for protecting FTO Analysis
products or services. In addition, While patentability speaks
a product may be eligible for to meeting the novelty and
exclusivity depending on the non-obviousness stan-
regulatory pathway followed. dards to obtain one or
Trade-secret protection may more patent claims, FTO
also be used to protect product refers to an analysis of the
and service elements where third-party patent landscape
patent protection is not possible relevant to the target product
or where trade-secret protection is you wish to bring to market. For
a better choice. Companies will often example, you may feel comfortable
maintain details of a manufacturing process, that a new method of use and related
formulation know-how, a clinical model or formulation is patentable after conducting
methodology, scales and the like as trade for example antibiotics, anti-infl ammatories, a patentability search. Such a patentability
secrets. Effective trade-secret protec- anti-allergics and anti-neovascular agents search would likely not uncover that one or
tion strategy requires careful planning and that were previously used for non-ocular more third-party patents may block the only
customization depending on the technology indications. Likewise, new formulations cost-effective way to manufacture the new
and the context in which it is used, including of existing compounds can dramatically formulation on a large scale. A solid FTO
diligent use of confi dentiality agreements; a enhance the safety and effi cacy of a chemi- analysis is one way to avoid a momentum-
plan within your organization on how informa- cal entity. Finally, manufacturing patents can destroying surprise later.
tion will be shared (or not) and used; and be valuable by preventing competitors from The defi ning features of how the product
thorough tracking and enforcement. With the utilizing the most cost-effective method for will be used and manufactured are em-
proper protection, trade secrets can provide the target product. Once the type of subject ployed to create search terms for identifying
indefi nite protection. matter has been defi ned, one must look to third-party IP, which may preclude selling of
see if it is patentable. your target product in the market. Broadly
Patent Protection The two main requirements for being crafted search terms are well-advised. A good
Patents provide the holder with the right to granted a patent are that the invention must patent attorney will be able to help identify
exclude others from making, selling, using be novel and non-obvious. Novelty is a the defi ning features of your target product,
and importing the patented drug, device or straightforward test that looks to published create appropriate search terms and evalu-
method for a period of 20 years from fi ling. papers, granted patents, patent applications ate whether the references in question may
The types of patents relevant to this discus- and other references, collectively referred to preclude you from selling your target product
sion are: 1) Composition of Matter or Device as “prior art,” to determine whether or not the absent a license from the relevant third-party
6 | Review of Ophthalmology | November 2013
003_rp1113_news.indd 6 10/23/13 2:36 PM
W News
E
I
V
E
R
patent holder. In the event that a third-party of the compound for use in treating ophthal- (continued from page 5)
patent or patent application is deemed to be mic diseases, because previous research
different but still close to your target product had suggested it to be non-fruitful due to this family and found that the chil-
and it is owned by a large, litigious company, formulation issues. However, in an inventive dren with RP carry two copies of a
the reality is that weakly supported lawsuits moment, an ophthalmologist entrepreneur mutation at the dehydrodolichol di-
brought by deep pockets can create real formulates the compound successfully for phosphate synthase (DHDDS) gene,
problems for entrepreneurs at the point the animal experiments. The formulation work which makes the enzyme that syn-
target product becomes profi table. Moreover, and experimentation generates surprising
thesizes organic compounds called
problems can be created at the fundraising results that an eyedrop formulation of the
dolichols. In humans, dolichol-19,
stage if the potential investor discovers an compound is possible (i.e., stable) and that
containing 19 isoprene units, is the
FTO issue during due diligence and consid- it likely will be effi cacious in treating the
most abundant species.
ers the risk of lawsuit to substantially affect disease, thus yielding potentially patentable
the value proposition for your target product. formulation, method of use and possibly The DHDDS mutation, which was
FTO searches can range in price from several manufacturing claims. found in 2011, is the latest addition
thousand dollars to tens of thousands of dol- Despite the apparent simplicity of the to more than 60 gene mutations that
lars depending on the complexity of the target foregoing example, it is important to note have been implicated in RP. This
product, how crowded the patent landscape that the patent law Doctrine of Inherency is mutation appears to be prevalent in
is, and how many references are close to the often relevant within the context of repurpos-
RP patients of Ashkenazi Jewish ori-
target product. ing drugs. For example, a patent applicant
gin, and one in 322 Ashkenazi carries
The fi rst questions to ask before embark- might not be entitled to a new method of use
one copy of the mutation.
ing on a mission to bring a product (whether claim directed to the use of a new compound
from scratch or by repurposing) to market to treat glaucoma if a prior art reference “I knew from my previous expe-
are: “Do I have, or is there room for, ample IP describes an existing patented compound that rience in analyzing urine samples
protection to establish market share for the is in the same class as the new compound from liver disease patients that I
target product? And do I have, or is there a and that operates by the same mechanism can readily detect dolichols by liq-
path to, freedom to operate in the market as of action as the new compound. The reason uid chromatography and mass spec-
intended?” The answer to these questions will is that because the existing compound is in
trometry,” Dr. Guan said. Using
substantially affect your ability to attract suit- the same class and has the same MOA as
these techniques, he analyzed urine
able investment and partners for development the new compound, it is inherent that the
and blood samples from the six fam-
and commercialization of the target product. existing would also treat glaucoma. There-
ily members and found that instead
The importance of understanding the value fore, the prior art reference would anticipate
of your patent estate cannot be underscored (render non-novel) the claim directed to the of dolichol-19, the profi les from the
enough if you wish to begin with the end in use of the new compound to treat glaucoma. three siblings with RP showed doli-
mind. A formulation claim may still be available in chol-18 as the dominant species.
our example as the prior art suggests that The parents, each of whom carries
Other Considerations formulation challenges exist and that there is one copy of the mutated DHDDS
The strategy for global fi lings also needs to room for invention in solving these challenges,
gene, showed intermediate levels
be considered with the end partner/investor provided that the non-obviousness bar to
of dolichol-19 and higher levels of
in mind. Large pharmaceutical partners will patentability can be overcome.
dolichol-18 than their healthy child.
generally want and expect worldwide patent While the preceding hypothetical purports
Dr. Guan believes dolichol profi l-
fi lings in the largest eye-care markets, includ- to open the doors of potential opportunity,
ing the United States, Japan, and Europe (at be cautioned that (just as with all issues ing could effectively distinguish RP
least the big fi ve in the EU), Latin America and surrounding the complexity of patent law) caused by DHDDS mutation from
other large markets that respect IP. A common a competent patent attorney should be that caused by other mutations.
issue in the early stage of development is the consulted at the appropriate infl ection points Dr. Guan and his collaborators
IP budget, and generally the entrepreneur will along the way. hope to develop the dolichol profi l-
need to prioritize the most lucrative markets Again, it is important to defi ne the target
ing method as a fi rst-line diagnostic
based on commercial value. Early discussions product profi le early, identifying how the prod-
test to identify RP patients with ab-
with potential exit partners are invaluable in uct will be protected from competition, and to
normal dolichol metabolism. They
this regard. have early discussions with potential partners
Consider the scenario in which a pharma- to defi ne how the IP strategy will impact the think this mass spectrometry-based
ceutical company owns a patent covering, or value of the product. detection method will help physi-
claiming, the chemical structure of a small cians provide more personalized care
molecule that has expired. The company also The authors comprise the Corporate Devel- to RP patients, especially to young
owns patents claiming methods of using the opment Team at Ora Inc. They thank Andrew children whose retinal degeneration
small molecule to systemically treat various Warner, counsel at Ora, for his assistance and
has not fully developed.
diseases, and those patents will be in force input on this column. They welcome com-
for another 10 years. The method of use ments; for further information, please contact
(continued on page 10)
patents do not disclose eyedrop formulations [email protected].
November 2013 | Revophth.com | 7
003_rp1113_news.indd 7 10/23/13 2:36 PM
W Editorial
E
I
V Board
E
R
C
BUSINESS OFFICES
11 CAMPUS BOULEVARD, SUITE 100
ONTRIBUTORS NEWTOWN SQUARE, PA 19073
SUBSCRIPTION INQUIRIES [phone]
(USA ONLY); OUTSIDE USA, CALL [phone]
CHIEF MEDICAL EDITOR PLASTIC POINTERS
BUSINESS STAFF
Mark H. Blecher, MD Ann P. Murchison, MD, MPH
SALES MANAGER, NORTHEAST,
MID ATLANTIC, OHIO
BOTTOM LINE REFRACTIVE SURGERY JAMES HENNE
Dennis D. Sheppard, MD Arturo S. Chayet, MD [phone] [email protected]
CONTACT LENSES RETINAL INSIDER SALES MANAGER, SOUTHEAST, WEST
MICHELE BARRETT
Penny Asbell, MD Carl Regillo, MD, FACS [phone] [email protected]
Emmett T. Cunningham Jr., MD, PHD, MPH
CORNEA / ANTERIOR SEGMENT CLASSIFIED ADVERTISING
Thomas John, MD TECHNOLOGY UPDATE (888)-498-1460
Steven T. Charles, MD
GLAUCOMA MANAGEMENT Michael Colvard, MD VICE PRESIDENT OF OPERATIONS
CASEY FOSTER
Peter Netland, MD, PHD [phone] [email protected]
Kuldev Singh, MD THERAPEUTIC TOPICS
Mark Abelson, MD MANAGER EDUCATIONAL CONFERENCES/MEETINGS
PEDIATRIC PATIENT MEG MCDONALD
WILLS RESIDENTS CASE SERIES [phone] [email protected]
Christopher M. Fecarotta, MD
David Perlmutter, MD
PRODUCTION MANAGER
A SCOTT TOBIN
[phone] [email protected]
B
DVISORY OARD SUBSCRIPTIONS
$63 A YEAR, $99 (U.S.) IN CANADA,
$158 (U.S.) IN ALL OTHER COUNTRIES.
PENNY A. ASBELL, MD, NEW YORK CITY WILLIAM G. MARTIN, MD, OREGON, OHIO SUBSCRIPTIONS E-MAIL: [email protected]
CIRCULATION E-MAIL: [email protected]
WILLIAM I. BOND, MD, PEKIN, ILL. MIKE S. MCFARLAND, MD, PINE BLUFF, ARK.
ALAN N. CARLSON, MD, DURHAM, N.C. JEFFREY B. MORRIS, MD, MPH, ENCINITAS, CALIF.
Y. RALPH CHU, MD, EDINA, MINN. MARLENE R. MOSTER, MD, PHILADELPHIA CIRCULATION
PO BOX 2026, SKOKIE, IL 60076
ADAM J. COHEN, MD, DOWNERS GROVE, ILL. ROBERT J. NOECKER, MD, FAIRFIELD, CONN. [phone]
UDAY DEVGAN, MD, FACS, LOS ANGELES ROBERT OSHER, MD, CINCINNATI OUTSIDE USA: [phone]
FAX: [phone]
ERIC DONNENFELD, MD, ROCKVILLE CENTRE, N.Y. MARK PACKER, MD, EUGENE, ORE.
DANIEL S. DURRIE, MD, KANSAS CITY, MO. STEPHEN PASCUCCI, MD, BONITA SPRINGS, FLA. SENIOR CIRCULATION MANAGER
ANTHONY GUADAGNINO
ROBERT EPSTEIN, MD, MCHENRY, ILL. PAUL PENDER, MD, BEDFORD, N.H. [phone] [email protected]
ROBERT D. FECHTNER, MD, NEWARK, N.J. CHRISTOPHER J. RAPUANO, MD, PHILADELPHIA
WILLIAM J. FISHKIND, MD, TUCSON, ARIZ. AUGUST READER III, MD, SAN FRANCISCO
JAMES P. GILLS, MD, TARPON SPRINGS, FLA. TONY REALINI, MD, MORGANTOWN, W.V. CHIEF OPERATING OFFICER
HARRY GRABOW, MD, SARASOTA, FLA. KENNETH J. ROSENTHAL, MD, GREAT NECK, N.Y. JEFF MACDONALD
DOUGLAS K. GRAYSON, MD, NEW YORK CITY ERIC ROTHCHILD, MD, DELRAY BEACH, FLA. CEO, INFORMATION GROUP SERVICES
R. BRUCE GRENE, MD, WICHITA, KAN. SHERI ROWEN, MD, BALTIMORE MARC FERRARA
THOMAS S. HARBIN, MD, MBA, ATLANTA JAMES J. SALZ, MD, LOS ANGELES SENIOR VICE PRESIDENT, HUMAN RESOURCES
DAVID R. HARDTEN, MD, MINNEAPOLIS INGRID U. SCOTT, MD, MPH, HERSHEY, PA. LORRAINE ORLANDO
KENNETH J. HOFFER, MD, SANTA MONICA, CALIF. JOEL SCHUMAN, MD, PITTSBURGH VICE PRESIDENT, CREATIVE SERVICES & PRODUCTION
JACK T. HOLLADAY, MD, MSEE, HOUSTON GAURAV SHAH, MD, ST. LOUIS MONICA TETTAMANZI
JOHN D. HUNKELER, MD, KANSAS CITY, MO. DAVID R. STAGER JR., MD, DALLAS VICE PRESIDENT, CIRCULATION
THOMAS JOHN, MD, TINLEY PARK, ILL. KARL STONECIPHER, MD, GREENSBORO, N.C. EMELDA BAREA
ROBERT M. KERSHNER, MD, MS, FACS, BOSTON JAMES C. TSAI, MD, NEW HAVEN, CONN.
GUY M. KEZIRIAN, MD, PARADISE VALLEY, ARIZ. VANCE THOMPSON, MD, SIOUX FALLS, S.D.
TERRY KIM, MD, DURHAM, N.C. FARRELL C. TYSON, MD, CAPE CORAL, FLA.
TOMMY KORN, MD, SAN DIEGO R. BRUCE WALLACE III, MD, ALEXANDRIA, LA.
DAVID A. LEE, MD, HOUSTON, TX. ROBERT G. WILEY, MD, CLEVELAND
100 Avenue of the Americas
FRANCIS S. MAH, MD, PITTSBURGH FRANK WEINSTOCK, MD, CANTON, OHIO New York, NY 10013
NICK MAMALIS, MD, SALT LAKE CITY JACQUELINE M.S. WINTERKORN, MD, PHD, NEW YORK CITY
REVIEW OF OPHTHALMOLOGY (ISSN 1081-0226; USPS No. 0012-345) is published monthly, 12 times per year by Jobson Medical Information.
100 Avenue of the Americas, New York, NY 10013-1678. Periodicals postage paid at New York, NY and additional mailing offi ces. Postmaster: Send
address changes to Review of Ophthalmology, PO Box 2026, Skokie, IL 60076, USA. Subscription Prices: US One Year $63.00, US Two Year $112.00,
Canada One Year $99.00, Canada Two Year $181.00, Int’l One Year $158.00, Int’l Two Year $274.00. For subscription information call [phone]
(USA only); outside USA, call [phone]. Canada Post: Publications Mail Agreement #40612608. Canada Returns to be sent to Bleuchip Inter-
national, P.O. Box 25542, London, ON N6C 6B2.V
8 | Review of Ophthalmology | November 2013
003_rp1113_news.indd 8 10/23/13 2:37 PM
WELCOME TO THE
ERA OF CENTURION
®
Optimize every moment of your cataract removal
procedure with the NEW CENTURION® Vision System.
Active Fluidics™
Automatically optimizes chamber stability
by allowing surgeons to customize and
control IOP throughout the procedure.
Balanced Energy™
Enhances cataract emulsification efficiency
using OZil® Intelligent Phaco and the new
INTREPID® Balanced Tip design.
Applied Integration™
Designed to work seamlessly with other
Alcon technologies for an integrated
cataract procedure experience.
Learn more about the new era of cataract procedures.
Visit MyAlcon.com.
©2013 Novartis 8/13 CNT13017JAD
For important safety information, please see adjacent page.
RP1113_Alcon Centurion.indd 1 10/17/13 10:34 AM
W News
E
I
V
E
R
(continued from page 7) the Sackler School of Graduate Biomedical Sciences
“Since the urine samples gave us more distinct profi les have identifi ed a possible topical treatment for AMD
than the blood samples, we think that urine is a better in a study of mice that shows promise for clinical use.
clinical material for dolichol profi ling,” he said. Urine The fi ndings, published in PLoS ONE, are the fi rst to
collection is also easier than a blood draw and the sam- report successful topical use of a compound capable
ples can be conveniently stored with a preservative. The of inhibiting symptoms associated with both dry AMD
team is now pursuing a patent for this new diagnostic and wet AMD and could represent a breakthrough for
test for the DHDDS mutation. treatment of these conditions.
There are currently no treatments for RP, but Dr. The team of researchers from Tufts, led by Rajendra
Guan hopes his research will shed light on potential drug Kumar-Singh, PhD, reported in their proof-of-concept
design strategies for treating RP caused by DHDDS study that topical application of a compound called
mutation. “We are now researching ways to manipulate PPADS (pyridoxalphosphate-6-azophenyl-2’,4’-disul-
the dolichol synthesis pathway in RP patients with the fonic acid) inhibits damage to ocular tissue that impacts
DHDDS mutation so that the mutated enzyme can still the individual’s ability to see color and fi ne detail, as
produce enough dolichol-19, which we believe may be well as reducing neovascularization related to advanced
important for the rapid renewal of retinal tissue in a AMD.
healthy individual,” he says. According to the National Eye Institute, more than
7 million people in the United States are at substantial
risk of developing AMD. Only the wet form of AMD
Topical AMD Treatment
can be treated, with injections every four to 12 weeks
Shows Promise that can be uncomfortable, risky and burdensome to pa-
tients. The development of a topical eye-drop treatment
Researchers from Tufts University School of Medicine and that works in both dry and wet AMD could increase
treatment adherence and reduce patient discomfort by
reducing or removing the need for direct injections.
CENTURION® VISION SYSTEM
IMPORTANT SAFETY INFORMATION “An ideal therapy would be one that can be self-
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. administered daily by patients. Further studies are
As part of a properly maintained surgical environment, it is recommended that a backup IOL
Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform needed to determine safety, dosage, and other factors
as expected.
before advancement of this therapy towards clinical tri-
INDICATION: The CENTURION® Vision System is indicated for emulsification, separation,
irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous als, but our study suggests that there’s signifi cant prom-
aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular
lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® ise for the development of self-administered topical
intraocular lenses into the eye following cataract removal.
treatments for age-related macular degeneration in hu-
The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular
lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof® lenses mans,” said Dr. Kumar-Singh, an associate professor of
SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are
specifically indicated for use with this inserter, as indicated in the approved labeling of those ophthalmology at Tufts University School of Medicine.
lenses.
To test the effectiveness of a topical application of
WARNINGS: Appropriate use of CENTURION® Vision System parameters and accessories
is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle PPADS, the team of researchers induced the tissue
heights, high power settings, extended power usage, power usage during occlusion conditions
(beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively damage and blood vessel growth characteristics of
tight incisions, and combinations of the above actions may result in significant temperature
increases at incision site and inside the eye, and lead to severe thermal eye tissue damage. AMD in anesthetized mice. The topical treatment was
Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior then administered every 24 hours for three consecutive
to entering the eye. Ensure that tubings are not occluded or pinched during any phase of
operation. days. The researchers then examined the eye tissues
The consumables used in conjunction with ALCON® instrument products constitute a complete one week later to assess for progression of the damage
surgical system. Use of consumables and handpieces other than those manufactured by Alcon
may affect system performance and create potential hazards. and blood vessel growth.
AEs/COMPLICATIONS: Inadvertent actuation of Prime or Tune while a handpiece is in the
“Our study found that topical application of the
eye can create a hazardous condition that may result in patient injury. During any ultrasonic
procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a PPADS compound works on two fronts” said fi rst au-
second instrument. Another potential source of metal particles resulting from any ultrasonic
handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip. thor Kerstin Birke, PhD, a postdoctoral scholar at
ATTENTION: Refer to the Directions for Use and Operator’s Manual for a complete listing of
indications, warnings, cautions and notes. Tufts. “First, it stops the damage to eyes caused by
pores formed in the membrane, which leads to cell
death within the eye, by stopping an immune system
process known as complement, which is responsible
for dry AMD. Second, it prevents the formation of the
blood vessels that can leak and damage the eye, a pro-
© 2013 Novartis 9/13 CNT13017JAD
cess associated with wet AMD.”
003_rp1113_news.indd 10 10/25/13 11:23 AM