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2015 – The Year in Review
Emmett Cunningham M.D., Ph.D., M.P.H.
Partner, Clarus Ventures, LLC
OIS Attendance Over Time
0
100
200
300
400
500
600
700
800
900
1000
2009 2010 2011 2012 2013 2014 2015
> 900
> 400
OIS@AAO
OIS@ASCRS
OIS@AAO 2015
Perspectives May Differ
Drugs
Original NDA/BLA Approvals – 1988 to 2015Center for Drug Evaluation and Research
Data provided by :
Wiley A. Chambers, MDSupervisory Medical OfficerDivision of Transplant and Ophthalmology Products
0
20
40
60
80
100
120
140
Total Ophthalmic Approvals Total Approvals
Linear (Total Ophthalmic Approvals) Linear (Total Approvals)
• Range: 0 – 9• Mean: 4.4• Median: 4
Ophthalmic / Year: Stable
Original NDA/BLA ApprovalsCenter for Drug Evaluation and Research - FY2015
Gary Novack, PhDPharma . Logic Consulting, Inc.
111
2
0
20
40
60
80
100
120
Ophthalmic
Non-Ophthalmic
October 1, 2014 thru September 30, 2015
• Olopatadine ophthalmic solution (PAZEO®), 0.7%, a mast cell stabilizer
indicated for the treatment of ocular itching associated with allergic conjunctivitis, January 30, 2015 (NDA) – Alcon Res, LTD.
• Phenylephrine hydrochloride (Phenylephrine Hydrocloride), 2.5% &
10%, an alpha-1 adrenergic receptor agonist indicated to dilate the pupil, January 15, 2015 (NDA) – Akorn, Inc.
1.8% Ophthalmic
Data provided by :
Wiley A. Chambers, MDSupervisory Medical OfficerDivision of Transplant and Ophthalmology Products
Phase III Trials
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)
Humira®
(Adalimumab)
Positive Phase 3 Studies in Non-Infectious Intermediate, Posterior, and Panuveitis /
Behcet’s Disease
IgG1 Fc
Fab
Anti - TNFa
Vision-1 & 2 Studies Met Primary Endpoint Of Prolonging Time to Treatment Failure.
FDA Filing Submitted. Approval AnticipatedBy 4Q2016
http://acrabstracts.org/abstract/adalimumab-in-patients-with-inactive-non-infectious-uveitis-requiring-systemic-treatment/
http://abbvie.mediaroom.com/2015-05-05-AbbVie-Announces-Pivotal-Phase-3-Data-Evaluating-Efficacy-and-Safety-of-HUMIRA-adalimumab-in-Patients-with-Non-Infectious-Intermediate-Posterior-or-Panuveitis
Lifitegrast 5.0%LFA Inhibitor
Dry Eye
Corneal Staining
OPUS-3 Phase 3 Trial Met Primary (12 wks) & Key Secondary (2 & 6 wks) Endpoints - Improvement in Dry Eye Symptoms
Data to support FDA resubmission 1Q2016
Phase 2 Dose Ranging
Latanoprostene bunodophthalmic solution 0.024%
NDA Submitted, July 24, 2015
Expected US Launch, 2H2016July, 2016 PDUFA
http://ir.valeant.com/investor-relations/news-releases/news-release-details/2014/Bausch--Lomb-and-Nicoxs-Glaucoma-Candidate-VESNEO-latanoprostene-bunod-Meets-Primary-Endpoint-in-Phase-3-Studies/default.aspx
Met Phase 3 Primary EndpointNon-Inferiority vs Timolol
Once Daily ROCK / NET InhibitorLowers EVP
Preparing NDA Filing for RhopressaTM in 3Q2016
Rocket 2
Rocket 1
Rocket 2 met primary endpoint –non-inferior to Timolol
Rocket 1 met secondary endpoint –supportive
Upcoming Milestones …
FovistaTM Phase 3 TrialsIn Wet AMD
Combined Trial Data 4Q2016
Fovista 1.5mg + Lucentis (N=311) Consistent w/Lucentis dosing schedule Q4W approved in EU*
Lucentis 0.5mg (N=311) Consistent w/Lucentis dosing scheduleQ4W approved in EU*
OPH1002N = 622
Year 1
Fovista 1.5mg + Lucentis (N=311) Q8W (pre-specified PRN therapy during Q4W non-treating months)
Lucentis 0.5mg (N=311) Q8W (pre-specified PRN therapy during Q4W non-treating months)
Fovista 1.5mg + Avastin 1.25mg /Eylea 2mg (N=311) Avastin: Q4W / Eylea: Q8WAvastin Q4W / Eylea Q4W for 3 months, then Q8W
Avastin 1.25mg / Eylea 2mg (N=311) Avastin Q4W / Eylea Q8WAvastin Q4W / Eylea Q4W for 3 months, then Q8W
Year 2
OPH1003N = 622
OPH1004N = 622
PrimaryEndpoint
• Positive Phase 2 results reported in allergic conjunctivitis - October, 2014
• Phase 3 trial in moderate to severe allergic conjunctivitis topline data expected 1Q 16
• Potential BLA filing 2H 17
Phase 2 AC Data
Receptor
EBI-005
Treating late phase response as shown by separation over 5 hours
Isunakinra (EBI-005): Topically administered IL-1 receptor blocker
p=0.033
p=0.046
Phase 2 Data Anticipated 2016
X-linked retinoschisis (XLRS)
http://webeye.ophth.uiowa.edu/eyeforum/atlas/pages/XLRS.htm
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
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
$39.5 Bn
Anti-VEGF/Retina
Glaucoma
Dry Eye
All Other
IVT 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
How Would You Treat a New wet AMD Patient?
0.9%
13.7%
21.1%
64.3%
1.9%
34.5%
24.5%
39.4%
0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00%
Other
Lucentis
Eylea
Avastin
Ex-USA USA
2015 Membership Survey
Bevacizumab Ranibizumab
Am J Ophthalmol 2014, 157:825-833.
Study-Enforced Compliance Results in 4-5 Letter Increased
Mean Gain –As Much
As Effective Add-On Therapy
Strong Correlation Between Injection Frequency and Vision Gain
Scientific Breakthrough …
Nature. 2015 Jul 30;523(7562):607-11.
“Sterol eye drops reverse cataracts in mice”
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/
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
Devices
3007
73
0
500
1000
1500
2000
2500
3000
3500
Ophthalmic
Non-Ophthalmic
2.4% of Total
510(k) ClearancesDivision of Ophthalmic and Ear, Nose and Throat Devices - FY2015
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVMClinReg Consulting Services, Inc.
0
10
20
30
40
50
60
70
80
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
PMA 510(k)
PMA Approvals & 510(k) Clearances – 2004 to 2015Division of Ophthalmic and Ear, Nose and Throat Devices
73
4
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVMClinReg Consulting Services, Inc.
PMA ApprovalsDivision of Ophthalmic and Ear, Nose and Throat Devices- FY2015
53
4
0
10
20
30
40
50
60
Ophthalmic
Non-Ophthalmic
7.0% of Total
October 1, 2014 thru September 30, 2015• Kamra® Inlay• AcrySof® IQ ReSTOR® +2.5 D Intraocular Lens (IOL)• TECNIS® MULTIFOCAL IOL,+2.75 D and +3.25 D • STAR S4 IR Excimer Laser System and iDesign Advanced
WaveScan Studio System
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVMClinReg Consulting Services, Inc.
Noteworthy Approvals …
FDA Approved*April 17, 2015
*For intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 D to -0.75 D with less than or equal to 0.75 D of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add.
US Commercial Lauch May, 2015. Over 1000 KAMRA inlay surgeries completed to date.
FDA Approved*De Novo Classification
June 18, 2015
*The BrainPort V100 is an oral electronic vision aid that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451779.htm
De Novo Approvals – 2004 to 2015Center for Devices and Radiological Health
0
5
10
15
20
25
30
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
de novo 510(k)
Increasing Number of De Novo Approvals“A regulatory pathway for some low- to moderate-risk medical devices that are not
substantially equivalent to an already legally-marketed device.”
LipiFlow® Thermal Pulsation SystemTearScience® , Inc.; June, 2011
BrainPort® V100 Oral Visual Aid DeviceWicab, Inc.; June, 2015
Data provided by :Malvina B. Eydelman, MDDirectorDivision of Ophthalmic, and Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVMClinReg Consulting Services, Inc.
Upcoming Milestones …
Raindrop ® Near Vision InlayPMA Submission Accepted by FDA
November 10, 2015
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/
Handheld Unit
Disposable Tip with Hydrogel
Lacrimal Gland
Pivotol Study OngoingDe Novo Classification
FDA Filling Anticipated 3Q2016
Funding
NEI Funding Flat, but …At 1999 Level After Adjusting for Inflation
Data provided by :
Mala Dutta, Ph.D.Office of Translational Research, NEI
$676K
$411K
10.4%10.5%
9.0%
7.2%
3.8% 4.1%
8.7%
15.0%
19.1%19.2%
17.3%18.1%
18.7%
17.1%
19.3%
16.9%
15.8%15.5%15.3%
12.5%12.4%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%Percent of Total Venture Capital Invested in Biotech
Relative BiotechInvesting Down
0
5
10
15
20
25
30
Bill
ion
s ($
)Venture Capital Investments Over Time
Biotech Software
Absolute BiotechInvesting Up at ~ $5.6 Bn
0
100
200
300
400
500
600
700
800
900
1000
Number of "First Financings" of New Startups
Biotech Software
Absolute BiotechDeals Stable ~ 100 Deals/Year
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
Biotech + Device Venture CapitalInvested vs Raised
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
$3.4
$6.6
$7.9
$6.1
$5.2
$1.8
$3.7 $3.6 $3.9
$6.1
$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)
Fundraised ($Bn)
Courtesy Jon Norris
Amounts Up Significantly ~28%Gap Narrowing
business intelligence
Ophthalmic Investments Over Time (1999 – 2015*)
1 2 25 5
810
3
10
5
11
7
1311
95
21 5
2 3
9 5
7
14
9
10
6
11
8
1
0
100
200
300
400
500
600
0
5
10
15
20
25
30
# Biotech Deals # Device Deals VC Investment ($USD, Millions)
*2015 figures through OctoberSOURCE: Strategic Transactions
OphthalmicVC Funding Stable
~ $400 - 500M / year
Fewer Device Deals
($M)# Deals
77
30
22 22 21 1916
11 9 90
10
20
30
40
50
60
70
80
90
Courtesy Jon Norris
US Biotech Series AInvestments* By Indications – 2009 to 3Q2015
* > $2M
Courtesy Jon Norris
US Device Series AInvestments* By Indications – 2009 to 3Q2015
* > $2M
46 4542
2926
1411 10
5 50
5
10
15
20
25
30
35
40
45
50
VC Investment By Ophthalmic Indication (1999-2015*)
*2015 figures through OctoberSOURCE: Strategic Transactions
49
37
2119
1214
10 7
14
10
34
0
10
20
30
40
50
60
0
100
200
300
400
500
600
700
800
900
1,000
1,100
1,200
Nu
mb
er of D
eals
Pri
vate
Pla
cem
ents
($
M)
Dollars ($ Millions)Number of Deals
Biotech Stock Index (NBI) Continues UpwardDespite Corrections . . .
2008
Courtesy David Nierengarten, Wedbush
(M)
IPOs Completed in the USA by Sector1995 to 2015
One in Six IPOs in Healthcare
Courtesy David Nierengarten, Wedbush
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Percent of All VC-Backed IPOs by Sector
Biotech Software Other
50% of Recent VC-Backed IPOs Biotech
0
20
40
60
80
100
120
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Ophtho
Medtech
Biotech
Recession
- 398
- 312
- 27
Healthcare IPOs by Year - Cyclic
Courtesy David Nierengarten, Wedbush
?
?
Ophthalmology IPOs by Year - Cyclic
1
2
4
1 1
3
1 1 1
2
6
4
0
1
2
3
4
5
6
7
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Recession
Courtesy David Nierengarten, Wedbush
Positives• Unemployment, low• Inflation, low• Interest rates, low• Consumer spending, continues
Negatives• GDP, modest• Business spending, low
EconomicIndicators
Mostly Positive
Courtesy David Nierengarten, Wedbush
Yield Curve Spread Over 20 Years(Treasury Interest Rates - 10 year - 2 year Spread)
Yield Curve Spread Inversion
Pre-dates Recession Recession
Inversion Inversion
Yield Curve Spread Suggests Further Growth
Yield Curve Spread Still Positive ~ + 1.5
Courtesy David Nierengarten, Wedbush
“The four most expensive words in the English language are…”
‘This time is different.’Sir John Templeton
(November 29, 1912 – July 8, 2008)
Mergers &Acquisitions
Biotech & Medtech M&A Activity 2005 to 3Q2015
Courtesy Joe Gilliam
42
49 51
3236
53 52
45 4650
46
9
34
27 27
23 2528
17
2118
36
0
10
20
30
40
50
60
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Medtech Biotech
Private Company AcquisitionsPossible Trend Toward Fewer Structured Deals
~ 40% Structured ~ 65% Structured
Courtesy Jon Norris
0%
20%
40%
60%
80%
100%
Biopharma
Non-Structured Structured
0%
20%
40%
60%
80%
100%
Device
Non-Structured Structured
$300M
$125M + Undisc CVP$66Bn
$50M + Undisc CVP
$300M + Undisc CVP
$124M + $1.1Bn CVP
$51M + $291M CVP
$20M $379M
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 Centers of Innovation
Save the Dates5th Annual OIS@ASCRS
New Orleans, LAMay 5th, 2016
8th Annual OIS@AAOChicago, Illinois
October 13th, 2016
HASHTAG: #OISAAO
Jonathan PiazzaDirector
Will HanAnalyst
1
(SkQ1)
/
(KPI-121 – Cataract surgeryinflammation)
Ophthalmic Opportunity RoadmapGlaucoma Dry Eye AMD Other
(IBI-10090 – Cataract surgeryinflammation)
_________________________Source: Company information.
(IVT & Oral Kallikrein Inhibitor Program – DME)
(Eylea – Wet AMD, DME)
/
(Pan-90806 topical – Wet AMD)
(Jetrea – VMA)Marketed
Phase III
Phase II
Phase I
Pre-Clinical
(AKB-9778 – DME)
(Lifitegrast)
(GS010 – Gene therapy for LHON)
(RST-001 – Gene therapyfor RP & Dry AMD)
(Gene therapy for wet AMD and XLRP)
(ACU-4429 – Dry AMD)
/(BOL-303259-X)
/
(INO-8875)
(ALK-001 – Stargardt disease)
(SPK-RPE65 – Gene therapy forinherited retinal dystrophies)
(Gene therapy for Glaucoma-GT)
/
(Gene therapies for multiple indications)
/
(Anti-VEGF + Anti-PDGF)
/
(AAV.REP1 for choroidemia)
(RetinoStat – Gene therapy for Wet AMD)
(hI-con1 – Wet AMD)
(KPI-121)
(ENV515)
(ENV905 – Cataract surgery inflammation)
(AVA-101 – Gene therapy for Wet AMD)
/(PF582 – Wet AMD)
(Fovista – Wet AMD)
/
(X-82 oral anti-VEGF + anti-PDGF – Wet AMD)
(QLT091001 –LCA and RP)
(Ocuvia – DME)
/(ALG-1001 – DME)
/
(NS2 – SLS, Non-infectious uveitis)
(HuCNS-SC – Geographic Atrophy AMD)
(OpRegen – Dry AMD)
(hPRC Therapy for Retinitis Pigmentosa)
(EBI-005 – Allergic Conjunctivitis)
(RG7716 combo anti-VEGF/Ang2)
(Rhopressa & Roclatan)
(DARPin, Anti-VEGF / MP0112 – Wet AMD & DME)
/
(OTX-DP)
(OTX-TP)
(OTX-MP Moxifloxacin for bacterial conjunctivitis)
(OTX-DP forallergy)
(Helios insert)
PresbyopiaTherapies
(Liquid Vision – Presbyopia)
(RGN-259/GBT-201)
(OPT-302 – Wet AMD)
(rAAV-hRS1 – Gene therapy for XLRS)
/
(MIM-D3)
/
(L-PDDS)
(Eye-D Insert)
(EGP-437)
(Cis-UCA)
(Cross-linked hyaluronicacid)
(CycloASol)
(NT-503 – Wet AMD)
(TT-211/TT-231)
(RhoNova – Gene therapy for RP
(PRO-001 for RP)
(FB-08I8 for RP)
(RPE – Stargardt & Dry AMD)
/
Ophthalmology M&A Activity
___________________________Source: Company information, ThompsonSDC.
Therapeutics
($ in millions)
Devices
Date Target Acquiror Size Upfront Milestone Description
9/29/2015 Chauvin Opsia Cutting Edge Undisc. Undisc. Undisc.Manufacturer and developer of intraocular implants designed to perform cataract surgeries
9/3/2015 AqueSys Allergan $300 $300 $0XEN45 soft ocular shunt for treatment of glaucoma-related intraocular pressure
9/2/2015 Synergetics Valeant Pharmaceuticals 192 166 26 Vitreoretinal surgical devices
7/13/2015 Unilens Vision Valeant Pharmaceuticals 28 28 0Develops and sells specialty contact lenses under the C-Vue, Unilens, Sof-Form, Lombart and LifeStyle brands
7/6/2015 Oculeve Allergan Undisc. 125 Undisc.OD-01 nasal neurostimulation device that increases tear production in patients with dry eye disease
6/18/2015 Lumenis XIO Group 510 510 0 Ophthalmic surgical devices
5/8/2015 Paragon Vision Sciences Valeant Pharmaceuticals Undisc. Undisc. Undisc. Manufacturer of specialty contact lenses
5/4/2015 Improved Vision Systems OphthaliX 3 3 0Medical devices for diagnosis and treatment of a variety of ophthalmic diseases
Date Target Acquiror Size Upfront Milestone Disease Area
11/9/2015 Ocata Astellas $379 $379 $0 Stargardt's Disease, Dry AMD, Myopic Macular Degeneration
9/15/2015 InSite Vision Sun Pharmaceutical 48 48 0 Bacterial Infection, Surgical Inflammation
8/26/2015 R-Tech Ueno (Remaining Stake) Sucampo Pharmaceuticals 278 278 0 Glaucoma
8/3/2015 Foresight Biotherapeutics Shire 300 300 0 Pink Eye
11/20/2014 Potentia Pharmaceuticals Apellis Pharmaceuticals Undisc. Undisc. Undisc. Age-Related Macular Degeneration
11/17/2014 Allergan Actavis 66,000 66,000 0 Multiple
Ophthalmology Licensing Activity($ in millions)
___________________________Source: Company information, RecapIQ.1. Total includes upfront and potential milestone payments.
Date Licensor/Seller Licensee/Buyer Upfront Milestone Total(1) Subject
11/2015 Mimetogen Allergan $50 Undisc. Undisc. Exclusive licensing agreement to develop and commercialize MIM-D3 against dry eye
10/2015 Atheln Nemus Bioscience Atheln to collaborate on development of Nemus' NB-1111 against open angle glaucoma
10/2015 Novaliq Ursapharm Arzneimittel Ursapharm to commerclialize Novaliq's EvoTears against dry eye disease in Europe
9/2015 Ramot Aerie Pharmaceuticals Collaboration on Tel Aviv University's anti-beta amyloid for ocular diseases
9/2015 Mannin Research Q BioMed Q BioMed to inlicense and acquire Glaucoma assets of Mannin Research
9/2015 Alcon Recipharm Recipharm to acquire Alcon's manufacturing facility for ophthalmology products
8/2015 Repugen Hanmi Pharmaceutical Repebody antibody platform collaboration for eye and systemic diseases
8/2015 Midatech Pharma Ophthotech Midatech's Q Sphera sustained delivery of wet AMD and other ocular indications products
8/2015 ADF, Inc. Imprimis Non-exclusive rights to ophthalmic injectable and topical formulations in Canada
8/2015 Alimera Sciences SIFI SIFI to commercialize ILUVIEN for DME in Italy, San Marino and Vatican City
8/2015 GrayBug Aerie Pharmaceuticals Option to polymer-based sustained-release versions of Aerie's ophthalmic products
7/2015 River Vision CMC Biologics Agreement for cGMP production of teprotumumab for Grave's Orbitopathy
7/2015 EyeGate Pharma Valeant 1 33 34 EGP-437, dexamethasone phosphate delivered using EyeGate II for uveitis, WW ex-U.S.
7/2015 Mablife Elsalys Biotech Anti-CD160 antibody against cancer and eye diseases
7/2015 AIST Astellas Pharma Drug discovery using IT Drug-Discovery Technologies for ocular and nephrology diseases
7/2015 AGTC Biogen 124 1,065 1,189 Option to develop gene therapies for ophthalmic diseases
6/2015 Gensight Biologics Novasep CMO agreement for cGMP manufacturing of GS010 for Leber Hereditary Optic Neuropathy
6/2015 Broda Technologies Redwood Pharma IntelliGel supramolecular hydrogel slow-release for use in Dry Eye therapeutic RP101
6/2015 XL-protein DNX PASylation half-life extension for therapeutics in indications including ophthalmology
5/2015 EyeCRO NeuMedics NM108, delivered based on MiDROPS formulation platform, for ophthalmic disorders
5/2015 Portola Pharma Ora Syk inhibitor, PRT2761 for ophthalmic diseases
4/2015 Eyenovia Senju Pharmaceutical Microdosed therapeutics in Japan and the rest of Asia
4/2015 Clearside Biomedical Spark Therapeutics Option to microinjector technology to deliver gene therapies to the back of the eye
4/2015 4D Molecular AGTC Directed Vector Evolution platform for AAV vectors for ophthalmic disease indications
4/2015 Santen R-Tech Ueno Purchased DE-105, a neurotrophic factor peptide, for persistent corneal epithelial defects
2/2015 AERI AyoxxA Biosystems Multiplexing technology for protein biomarker detection in the treatment of AMD
2/2015 Insite Vision NicOx 3 14 17 AzaSite and BromSite drug duration extension in the eye, in Europe and Africa
2/2015 Pfenex Hospira/Pfizer 51 291 342 PF582, a biosimilar version of LUCENTIS (ranibizumab injection) for retinal conditions
2/2015 Insite Vision NicOx 3 14 17 AzaSite, BromSite and AzaSite Xtra in Europe, Middle East and Africa
1/2015 Allegro Ophthalmics Hanmi Pharmaceutical 20 0 20 Luminate (ALG-1001), intraocular injection for vascular eye diseases in China and Korea
12/2014 Durect Santen Pharmaceutical 2 76 78 SABER technology to develop a sustained release product to deliver ophth drugs
11/2014 AVEO Oncology Ophthotech 3 103 106 Option to AV-951 (tivozanib), a VEGF inhibitor for ocular diseases worldwide ex-Asia