This document provides a summary of key events and developments in ophthalmology in 2015. It discusses growth in attendance at major ophthalmology conferences, FDA drug and device approvals, positive results from phase 3 trials of gene therapy for RPE65-mediated retinal dystrophy and Humira for uveitis. It also reviews trends in the use of anti-VEGF drugs to treat wet AMD, global rates of IVT injections, the ophthalmic drug market, and causes of blindness worldwide. Tables and graphs are included to illustrate drugs, procedures, technologies, and market data.
Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
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Masters of the Industry at OIS@AAO 2016.
Moderated By:
Jim Mazzo, Global President Ophthalmic Devices - Carl Zeiss Meditec
Participants:
Flemming Ornskov, MD, CEO - Shire
Mike Ball, CEO - Alcon
Ashley McEvoy, Company Group Chairman - Johnson & Johnson Vision Care
William J. Link, PhD, Managing Director - Versant Ventures
Ludwin Monz, PhD, President & CEO - Carl Zeiss Meditec
William Meury, Chief Commercial Officer - Allergan
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Posterior Segment Company Showcase - Allegro OphthalmicsHealthegy
Posterior Segment Company Showcase - Allegro Ophthalmics at OIS@AAO 2016.
Presenter:
Vicken Karageozian, MD, President & Chief Medical Officer
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Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
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Masters of the Industry at OIS@AAO 2016.
Moderated By:
Jim Mazzo, Global President Ophthalmic Devices - Carl Zeiss Meditec
Participants:
Flemming Ornskov, MD, CEO - Shire
Mike Ball, CEO - Alcon
Ashley McEvoy, Company Group Chairman - Johnson & Johnson Vision Care
William J. Link, PhD, Managing Director - Versant Ventures
Ludwin Monz, PhD, President & CEO - Carl Zeiss Meditec
William Meury, Chief Commercial Officer - Allergan
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Posterior Segment Company Showcase - Allegro OphthalmicsHealthegy
Posterior Segment Company Showcase - Allegro Ophthalmics at OIS@AAO 2016.
Presenter:
Vicken Karageozian, MD, President & Chief Medical Officer
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Anterior Segment Company Showcase - Sensimed AGHealthegy
Anterior Segment Company Showcase - Sensimed AG at OIS@AAO 2016.
Presenter:
David Bailey, CEO
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Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
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Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Anterior Segment Company Showcase - Z lensHealthegy
Anterior Segment Company Showcase - Z lens at OIS@AAO 2016.
Presenter:
Paul Beer, MD, Founder & CEO
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Anterior Segment Company Showcase - EnvisiaHealthegy
Anterior Segment Company Showcase - Envisia at OIS@AAO 2016.
Presenter:
Benjamin Yerxa, PhD, President
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Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
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Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...Healthegy
Presentation by AGTC at OIS@ASRS 2016.
Participant:
Stephen Potter, Chief Business Officer - AGTC
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Presentation from OIS@ASCRS 2016
Co-Moderators:
Gilbert H. Kliman, MD, Managing Director – InterWest Partners
Stephen Slade, MD
Company Presentations
Equinox | John Berdahl, MD, Founder & CEO
Presbyopia Therapies | Jim McCollum, Co-Founder
Stroma Medical | Doug Daniels, CEO
Eyenovia | Curt LaBelle, MD, Director
Wicab | Robert Beckman, President & COO
RETINA COMPANY SHOWCASE- Aerie PharmaceuticalsHealthegy
Panel Discussion by Aerie Pharmaceuticals at OIS@ASRS 2016.
Participant:
Casey Kopczynski, Chief Scientific Officer- Aerie Pharmaceuticals
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Welcome & Innovation Highlights at OIS@ASRS 2016.
Participant:
Emmett T. Cunningham Jr., MD, PhD, MPH, Partner – Clarus
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Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Crossroads Venture Group hosts monthly networking events and in march the focus was Medical Devices. David Wang was keyonter and we had three presenting companies pitch to a panel of experienced investors.
The Commonwealth Fund - Putting the Patient at the Center of the Digital Univ...Healthegy
Keynote Address - Presentation by Commonwealth Fund at Digital Healthcare Innovation Summit 2016
Participant:
David Blumenthal, MD, MPP, President & CEO – Commonwealth Fund
Introduced By:
Robert Mittendorff, MD, MBA, Partner – Norwest Venture Partners
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StartUp Health - Private Market Perspectives - Digital Healthcare Innovation ...Healthegy
Presentation by StartUp Health at Digital Healthcare Innovation Summit 2016.
Participant:
Katya Hancock, Director of Strategic Partnerships – StartUp Health
Introduced By:
Tom Salemi, Content Director – Healthegy
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DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
This document is designed as an introductory to medical students,nursing students,midwives or other healthcare trainees to improve their understanding about how health system in Sri Lanka cares children health.
PET CT beginners Guide covers some of the underrepresented topics in PET CTMiadAlsulami
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
Our mission is to provide a safe and supportive environment where our clients can receive the highest quality of care. We are dedicated to assisting our clients in reaching their objectives and improving their overall well-being. We prioritize our clients' needs and individualize treatment plans to ensure they receive tailored care. Our approach is rooted in evidence-based practices proven effective in treating addiction and mental health disorders.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Letter to MREC - application to conduct studyAzreen Aj
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
Cold Sores: Causes, Treatments, and Prevention Strategies | The Lifesciences ...The Lifesciences Magazine
Cold Sores, medically known as herpes labialis, are caused by the herpes simplex virus (HSV). HSV-1 is primarily responsible for cold sores, although HSV-2 can also contribute in some cases.
8. Original NDA/BLA Approvals – 1988 to 2015
Center for Drug Evaluation and Research
Data provided by :
Wiley A. Chambers, MD
Supervisory Medical Officer
Division 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
9. Original NDA/BLA Approvals
Center for Drug Evaluation and Research - FY2015
Gary Novack, PhD
Pharma . 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, MD
Supervisory Medical Officer
Division of Transplant and Ophthalmology Products
11. 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
Luxscore,bilateral
Study visit
Intervention Control
Mean MT Lux Score/Level - Bilateral
(mITT/safety population, n=29)
12. 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 Anticipated
By 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
13. 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
14. Phase 2 Dose Ranging
Latanoprostene bunod
ophthalmic solution 0.024%
NDA Submitted, July 24, 2015
Expected US Launch, 2H2016
July, 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 Endpoint
Non-Inferiority vs Timolol
15. Once Daily ROCK / NET Inhibitor
Lowers 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
17. FovistaTM Phase 3 Trials
In 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 schedule
Q4W approved in EU*
OPH1002
N = 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: Q8W
Avastin Q4W / Eylea Q4W for 3 months, then Q8W
Avastin 1.25mg / Eylea 2mg (N=311) Avastin Q4W / Eylea Q8W
Avastin Q4W / Eylea Q4W for 3 months, then Q8W
Year 2
OPH1003
N = 622
OPH1004
N = 622
Primary
Endpoint
18. • 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
19. Phase 2 Data
Anticipated 2016
X-linked retinoschisis (XLRS)
http://webeye.ophth.uiowa.edu/eyeforum/atlas/pages/XLRS.htm
25. 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
26. 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
28. 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
32. Global Ophthalmic Procedures - 2015
Vitrectomies
Laser
Photocoagulation
IVT Injections
Cataract, RLE,
Phakic IOLs
Laser Refractive
Glaucoma Filtering, Shunts, MIGs
Glaucoma Laser
All Other
22.2M
Market Scope ®Source: Market Scope Estimates; Courtesy Dave Harmon. http://market-scope.com/
33. 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
36. 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 2015
Division of Ophthalmic and Ear, Nose and Throat Devices
73
4
Data provided by :
Malvina B. Eydelman, MD
Director
Division of Ophthalmic, and
Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVM
ClinReg Consulting Services, Inc.
37. PMA Approvals
Division 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, MD
Director
Division of Ophthalmic, and
Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVM
ClinReg Consulting Services, Inc.
39. 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.
40. 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
41. De Novo Approvals – 2004 to 2015
Center 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 System
TearScience® , Inc.; June, 2011
BrainPort® V100
Oral Visual Aid Device
Wicab, Inc.; June, 2015
Data provided by :
Malvina B. Eydelman, MD
Director
Division of Ophthalmic, and
Ear, Nose and Throat Devices, FDA
Lee Kramm, MD, MSE & Judy Gordon, DVM
ClinReg Consulting Services, Inc.
47. 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
72. “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…
73. 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
74. 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
75.
76. An Eye on India and China
Intas Pharmaceuticals
Launches Razumab
‘Similar’ to Ranabizumab
Kanghong Biotech
Launches Combercept
‘Similar’ to Afilbercept
Sun Pharma
Acquires Insight - $48M
Emerging Centers of Innovation
82. (SkQ1)
/
(KPI-121 – Cataract surgery
inflammation)
Ophthalmic Opportunity Roadmap
Glaucoma Dry Eye AMD Other
(IBI-10090 – Cataract surgery
inflammation)
_________________________
Source: Company information.
(IVT & Oral Kallikrein Inhibitor Program – DME)
(Eylea – Wet AMD, DME)
/
(Pan-90806 topical – Wet AMD)
(Jetrea – VMA)
Marketed
Phase III
Phase II
Phase I
Pre-
Clinical
(AKB-9778 – DME)
(Lifitegrast)
(GS010 – Gene
therapy for LHON)
(RST-001 – Gene therapy
for RP & Dry AMD)
(Gene therapy for wet AMD and XLRP)
(ACU-4429 – Dry AMD)
/
(BOL-303259-X)
/
(INO-8875)
(ALK-001 – Stargardt disease)
(SPK-RPE65 – Gene therapy for
inherited retinal dystrophies)
(Gene therapy for
Glaucoma-GT)
/
(Gene therapies for multiple indications)
/
(Anti-VEGF +
Anti-PDGF)
/
(AAV.REP1 for choroidemia)
(RetinoStat – Gene therapy for Wet AMD)
(hI-con1 – Wet AMD)
(KPI-121)
(ENV515)
(ENV905 – Cataract
surgery inflammation)
(AVA-101 – Gene therapy for Wet AMD)
/
(PF582 – Wet AMD)
(Fovista – Wet AMD)
/
(X-82 oral anti-VEGF + anti-
PDGF – Wet AMD)
(QLT091001 –
LCA and RP)
(Ocuvia – DME)
/
(ALG-1001 – DME)
/
(NS2 – SLS, Non-infectious uveitis)
(HuCNS-SC – Geographic Atrophy AMD)
(OpRegen – Dry AMD)
(hPRC Therapy for Retinitis Pigmentosa)
(EBI-005 – Allergic Conjunctivitis)
(RG7716 combo anti-VEGF/Ang2)
(Rhopressa & Roclatan)
(DARPin, Anti-VEGF / MP0112 – Wet AMD & DME)
/
(OTX-DP)
(OTX-TP)
(OTX-MP Moxifloxacin for bacterial conjunctivitis)
(OTX-DP for
allergy)
(Helios insert)
Presbyopia
Therapies
(Liquid Vision – Presbyopia)
(RGN-259/GBT-201)
(OPT-302 – Wet AMD)
(rAAV-hRS1 – Gene therapy for XLRS)
/
(MIM-D3)
/
(L-PDDS)
(Eye-D Insert)
(EGP-437)
(Cis-UCA)
(Cross-linked hyaluronic
acid)
(CycloASol)
(NT-503 – Wet AMD)
(TT-211/TT-231)
(RhoNova – Gene
therapy for RP
(PRO-001 for RP)
(FB-08I8 for RP)
(RPE – Stargardt & Dry AMD)
/
83. Ophthalmology M&A Activity
___________________________
Source: Company information, ThompsonSDC.
Therapeutics
($ 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 $0
XEN45 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 0
Develops 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 0
Medical 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 $0 Stargardt's Disease, Dry AMD, Myopic Macular Degeneration
9/15/2015 InSite Vision Sun Pharmaceutical 48 48 0 Bacterial Infection, Surgical Inflammation
8/26/2015 R-Tech Ueno (Remaining Stake) Sucampo Pharmaceuticals 278 278 0 Glaucoma
8/3/2015 Foresight Biotherapeutics Shire 300 300 0 Pink Eye
11/20/2014 Potentia Pharmaceuticals Apellis Pharmaceuticals Undisc. Undisc. Undisc. Age-Related Macular Degeneration
11/17/2014 Allergan Actavis 66,000 66,000 0 Multiple
84. Ophthalmology Licensing Activity($ 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