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Five Trends in Ophthalmic Innovation ICO World ... · Department of Ophthalmology, California...
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Department of Ophthalmology, California Pacific Medical Center Department of Ophthalmology, Stanford University School of Medicine Francis I. Proctor Foundation, UCSF School of Medicine West Coast Retina Medical Group Clarus Ventures, LLC Five Trends in Ophthalmic Innovation Poised to Impact Global Eye Health Emmett T. Cunningham, Jr., M.D., PhD., M.P.H ICO World Ophthalmology Roundtable on Leadership Development (WORLD)
Transcript of Five Trends in Ophthalmic Innovation ICO World ... · Department of Ophthalmology, California...
Department of Ophthalmology,
California Pacific Medical Center
Department of Ophthalmology,
Stanford University School of Medicine
Francis I. Proctor Foundation,
UCSF School of Medicine
West Coast Retina Medical Group
Clarus Ventures, LLC
Five Trends in Ophthalmic Innovation Poised to Impact Global Eye Health
Emmett T. Cunningham, Jr., M.D., PhD., M.P.H
ICO World Ophthalmology Roundtable on
Leadership Development (WORLD)
Financial Disclosures
“What Conflict of Interest?
I work here in my spare time…”
Prognosticators …
1 - FundingLargely / Increasingly Private
(Private Equity / Corporate)
NEI Funding Flat, but …At 1999 Level After Adjusting for Inflation
Data provided by :
Mala Dutta, Ph.D.Office of Translational Research, NEI
$676K
$411K
Source: PricewaterhouseCoopers, Silicon Valley Bank
Total VC vs Biotech vs Device Investments (2001-2015)
Courtesy Jon Norris
$0
$5
$10
$15
$20
$25
$30
$35
$40
$45
$50
Total VC Dollars ($Bn) Biotech ($Bn) Device ($Bn)
$1.9Bn
$5.6Bn
$47Bn
Most DramaticIncreases NOT
Biotech or Devices
Lifescience Venture CapitalInvested (2005 – 2014)
Source: PricewaterhouseCoopers, Silicon Valley Bank
$6.0
$7.3
$9.1 $8.6
$6.6
$6.3
$7.7
$6.7
$6.7
$8.6
$0.0
$1.0
$2.0
$3.0
$4.0
$5.0
$6.0
$7.0
$8.0
$9.0
$10.0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Invested ($Bn)
Invested ($Bn)
Courtesy Jon Norris
But, Biotech and Devices
Also up ~ 30%
business intelligence
Ophthalmic Investments Over Time (1999 – 2015*)
1 2 25 5
810
3
10
5
11
7
1311
95
21 5
2 3
9 5
7
14
9
10
6
11
8
1
0
100
200
300
400
500
600
0
5
10
15
20
25
30
# Biotech Deals # Device Deals VC Investment ($USD, Millions)
*2015 figures through OctoberSOURCE: Strategic Transactions
Ophthalmic VCFunding Stable Overall
~ $400 - 500M / year
($M)# Deals2014 / 15
Device Funding Slow
Alcon ~ $670M ~1Bn
VC ~ $380M ~$500M
NEI ~ $665M ~$676M
2009 2015
+ etc…
NEI Funding Comparable to VC, but Modest in Comparison
to Industry at Large
Translational Research
Laboratory Research
Clinical Research
Treatments
Early Stage VCs Late Stage VCs
SBIR
Industry
Understand Funding Sources / Risks
Stage
SourceOf Funds
FundsRequired
AvailabilityOf Funds
Modified after: Center for Venture Research – University of New Hampshire
Pre-Seed Seed / Startup Early Late
FoundersFriendsFamily
SBIR / FoundationsAngels / Incubators
Institutional Investors (VC)
$50K $100K $1M $100M
Risk
Risk Not drawn to scale!
“Innovation Gap”
High
Low
VCsNEI Industry
VC Investment By Ophthalmic Indication (1999-2015*)
*2015 figures through OctoberSOURCE: Strategic Transactions
49
37
2119
1214
10 7
14
10
34
0
10
20
30
40
50
60
0
100
200
300
400
500
600
700
800
900
1,000
1,100
1,200
Nu
mb
er of D
eals
Pri
vate
Pla
cem
ents
($
M)
Dollars ($ Millions)Number of Deals
2 – RetinaEnhanced Efficacy Through Improved Compliance
(Sustained Release & Gene Therapy)
51%
8%
5%
4%
4%
3%
3%
1%
21%
Cataract
Glaucoma
AMD
Corneal Opacity
Childhood
Refractive Error
Trachoma
Diabetic Retinopathy
Undetermined
Global Causes of BlindnessWorld Health Organization - 2010
http://www.who.int/blindness/data_maps/en/
Retina – 6%and growing
Global Ophthalmic Procedures - 2015
Vitrectomies
Laser Photocoagulation
IVT Injections
Cataract, RLE, Phakic IOLs
Laser Refractive
Glaucoma Filtering, Shunts, MIGsGlaucoma Laser
All Other
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
Retina – 25.7M
24.2M
Global Ophthalmic Pharmaceutical Market Revenues by Indication
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
9.3
16.5
4.7
6.1
3.1
3.7
3.8
4.2
0
5
10
15
20
25
30
35
2015 2020
$20.9 Bn
$30.5 Bn
Anti-VEGF/Retina
Glaucoma
Dry Eye
All Other
~ 54%
Sustained-ReleaseCorticosteroids
IVT a-VEGF Injections….
Courtesy Dr. Peter Karth and Dr. Marc Blumenkranz
Global IVT a – VEGF Injections
Source: Market Scope Estimates Market Scope ®
4.6M
Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0
5
10
15
20
25
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
United States Outside United States Global
(M)
17.6M
22.2MMost Growth OUS
Anti-VEGF for nAMD, DME, RVO
Market Scope ®
US Retina Specialist Treatment for Wet AMD
Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Q3-2013 Q3-2014 Q3-2015
Lucentis Eylea Avastin Other
61%
23%
12%
4%
Avastin
Eylea
Lucentis
Other
Bevacizumab Ranibizumab
Am J Ophthalmol 2014, 157:825-833.
Study-Enforced Compliance Results in 4-5 Letter
Mean Gain –As Much
As Effective Add-On Therapy
Strong Correlation Between Injection Frequency and Vision Gain
Sustained ReleaseFor Posterior Segment
Simultaneous Detection of Chemokines,
Cytokines, Growth Factors (eg, VEGF)
Free Drug ReleaseAs Particles Erode
Replenish MicropumpTM
Phase 2b 2Q2015
Phase 2b Ongoing
Pre-INDPre-IND
https://clinicaltrials.gov/ct2/show/NCT02510794?term=ranibizumab+sustained&rank=2
Ranibizumab (RBZ) Port Delivery System (RPDS)For Wet AMD – LADDER Trial
Phase 2 Data 1H2017
Gene Therapy in Ophthalmology At the Tipping Point ?
Sisyphus Snowball
Tipping Point
Positive Phase 3 Trial of SPK-RPE65 for the treatment of RPE65-mediated inherited retinal
dystrophies (IRDs).BLA Submission 2016
*As measured by the change in bilateral mobility testing between baseline and one year. The multicenter, pivotal Phase 3 trial randomized 31
subjects with confirmed RPE65 gene mutations. The ITT population included 21 subjects in the intervention group and 10 in the control group.
Leo A. The Gene Therapy Renaissance. April 18, 2013. http://hms.harvard.edu/news/gene-therapy-renaissance-4-18-13
0
1
2
3
4
5
6
BL D30 D90 D180 Y1
Lux
sco
re, b
ilate
ral
Study visit
Intervention Control
Mean MT Lux Score/Level - Bilateral
(mITT/safety population, n=29)
Phase 2 Data Anticipated 2016
X-linked retinoschisis (XLRS)
http://webeye.ophth.uiowa.edu/eyeforum/atlas/pages/XLRS.htm
3 – GlaucomaEnhanced Efficacy Through Improved Compliance
(Sustained Release & MIGS)
51%
8%
5%
4%
4%
3%
3%
1%
21%
Cataract
Glaucoma
AMD
Corneal Opacity
Childhood
Refractive Error
Trachoma
Diabetic Retinopathy
Undetermined
Global Causes of BlindnessWorld Health Organization - 2010
http://www.who.int/blindness/data_maps/en/
Glaucoma – 8%
Global Ophthalmic Procedures - 2015
Vitrectomies
Laser Photocoagulation
IVT Injections
Cataract, RLE, Phakic IOLs
Laser Refractive
Glaucoma Filtering, Shunts, MIGsGlaucoma Laser
All Other
2.8M
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
Global Ophthalmic Pharmaceutical Market Revenues by Indication
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
9.3
16.5
4.7
6.1
3.1
3.7
3.8
4.2
0
5
10
15
20
25
30
35
2015 2020
$20.9 Bn
$30.5 Bn
Anti-VEGF/Retina
Glaucoma
Dry Eye
All Other
~ 20%
Am J Ophthalmol 2005; 140:598-606
• Adherence Poor (< 50% by 6 months for most gtts)
• 2x higher with once daily therapy (prostaglandins) – still low
1234 Eligibile Beneficiaries
A Minority had “Good Adherence” Over Time
• 20% at 1 year
• 15% at 4 years
Sustained ReleaseDrugs for Glaucoma
IntracameralBimatoprost SR – P3
Punctal Plug
Latanaprost – P2
HeliosTM Insert
Travoprost – P2
Punctal Plug
Travoprost – P2
IntracameralTravoprost – P2
iStent
iStent® inject(G2)
iStent® SUPRA(G3)
“iStent” - Approved for Glaucoma SurgeryJune, 2012
Founded MIGS Space
CyPass ® Micro-Stent
CyPass ® Micro-StentPMA Submission Accepted by FDA
October, 2015
“Pivotal COMPASS Trial Results
Positive through Two Years”
http://transcendmedical.com/intent-to-file-premarket-approval-application-with-fda/
A Number of Followers in Clinical Development …
Hydrus Microstent
MicroShunt
XEN Glaucoma Implant
US Glaucoma Surgical Procedures (000)
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0
50
100
150
200
250
300
350
400
450
500
Filtration Tube Shunts MIGs-Other
2014 2015 (Forecast) 2020
All Growth in MIGSIn US
> 450,000
Global Glaucoma Surgical Procedures (000)
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
0
100
200
300
400
500
600
700
800
900
1000
Filtration Tube Shunts MIGs-Other
2015 2020
> 900,000
All Growth in MIGSGlobally
4 – CataractPharaceutical Treatment
51%
8%
5%
4%
4%
3%
3%
1%
21%
Cataract
Glaucoma
AMD
Corneal Opacity
Childhood
Refractive Error
Trachoma
Diabetic Retinopathy
Undetermined
Global Causes of BlindnessWorld Health Organization - 2010
http://www.who.int/blindness/data_maps/en/
Global Ophthalmic Procedures - 2015
Vitrectomies
Laser Photocoagulation
IVT Injections
Cataract, RLE, Phakic IOLs
Laser Refractive
Glaucoma Filtering, Shunts, MIGsGlaucoma Laser
All Other
22.2M
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
Nature. 2015 Jul 30;523(7562):607-11.
“Sterol eye drops reverse cataracts in mice”
Sterols target crystallin to restore lens transparency in mouse models of cataracts
Slit lamp biomicroscopy photographs from R120G cryAB mice dosed topically with c29 eyedrops
c29Vehicle
Lens Opacity
(Cataract)
Transparency Recovered
c29 binds and stabilizes the dimer of cryAB to reverse aggregation
www.viewpointtherapeutics.com
5 – India / ChinaCenters of Innovation
An Eye on India and China
1.3 Bn 1.4 Bn
“Necessity may be the mother in invention”*
BUT
“Prosperity is the father of innovation…..”
*“...let us begin and create in idea a State; and yet a true creator is necessity, which is the mother of our invention.”
The Republic, Book II, 369c, Plato
Plato
A strong and sustained culture of innovation is predicated upon a strong economy with real or perceived discretionary spending…
Global Contribution to World's GDP by Major Economies from 1 AD to 2003 AD
Maddison A (2007), Contours of the World Economy I-2030AD, Oxford University Press, ISBN 978-0199227204
Projected Relative Global Economies 2011 – 2030 - 2060
23% 28%16%
17%
28%
28%
6%
11%18%17%
12% 9%18%
15% 14%
12%12% 12%
7% 4% 3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2011 2030 2060
USA
China
India
Euro Area
Other OECD
Other non-OECD
Japan
An Eye on India and China
Intas PharmaceuticalsLaunches Razumab
‘Similar’ to Ranabizumab
Kanghong BiotechLaunches Combercept‘Similar’ to Afilbercept
Sun PharmaAcquires Insight - $48M
Emerging as Centers of Innovation
Opinions May Vary …
