+ All Categories
Home > Documents > 2015 The Year in Review - OIS€¦ · 22/11/2015  · OIS Attendance Over Time 0 100 200 300 400...

2015 The Year in Review - OIS€¦ · 22/11/2015  · OIS Attendance Over Time 0 100 200 300 400...

Date post: 09-Oct-2020
Category:
Upload: others
View: 1 times
Download: 0 times
Share this document with a friend
84
2015 The Year in Review Emmett Cunningham M.D., Ph.D., M.P.H. Partner, Clarus Ventures, LLC
Transcript
Page 1: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

2015 – The Year in Review

Emmett Cunningham M.D., Ph.D., M.P.H.

Partner, Clarus Ventures, LLC

Page 2: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 3: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 4: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 5: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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 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

Page 6: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Perspectives May Differ

Page 7: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Drugs

Page 8: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 9: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 10: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Phase III Trials

Page 11: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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)

Page 12: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 13: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 14: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 15: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 16: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Upcoming Milestones …

Page 17: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 18: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

• 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

Page 19: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Phase 2 Data Anticipated 2016

X-linked retinoschisis (XLRS)

http://webeye.ophth.uiowa.edu/eyeforum/atlas/pages/XLRS.htm

Page 20: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 21: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 22: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

IVT Injections….

Courtesy Dr. Peter Karth and Dr. Marc Blumenkranz

Page 23: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 24: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Anti-VEGF for nAMD, DME, RVO

Page 25: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 26: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 27: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Bevacizumab Ranibizumab

Page 28: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 29: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Scientific Breakthrough …

Page 30: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Nature. 2015 Jul 30;523(7562):607-11.

“Sterol eye drops reverse cataracts in mice”

Page 31: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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/

Page 32: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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/

Page 33: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 34: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Devices

Page 35: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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.

Page 36: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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.

Page 37: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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.

Page 38: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Noteworthy Approvals …

Page 39: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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.

Page 40: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 41: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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.

Page 42: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Upcoming Milestones …

Page 43: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Raindrop ® Near Vision InlayPMA Submission Accepted by FDA

November 10, 2015

Page 44: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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/

Page 45: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Handheld Unit

Disposable Tip with Hydrogel

Lacrimal Gland

Pivotol Study OngoingDe Novo Classification

FDA Filling Anticipated 3Q2016

Page 46: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Funding

Page 47: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 48: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 49: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

0

5

10

15

20

25

30

Bill

ion

s ($

)Venture Capital Investments Over Time

Biotech Software

Absolute BiotechInvesting Up at ~ $5.6 Bn

Page 50: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 51: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 52: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 53: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 54: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 55: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 56: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 57: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 58: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Biotech Stock Index (NBI) Continues UpwardDespite Corrections . . .

2008

Courtesy David Nierengarten, Wedbush

Page 59: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

(M)

IPOs Completed in the USA by Sector1995 to 2015

One in Six IPOs in Healthcare

Courtesy David Nierengarten, Wedbush

Page 60: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 61: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 62: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

?

Page 63: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

?

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

Page 64: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Positives• Unemployment, low• Inflation, low• Interest rates, low• Consumer spending, continues

Negatives• GDP, modest• Business spending, low

EconomicIndicators

Mostly Positive

Courtesy David Nierengarten, Wedbush

Page 65: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 66: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

“The four most expensive words in the English language are…”

‘This time is different.’Sir John Templeton

(November 29, 1912 – July 8, 2008)

Page 67: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Mergers &Acquisitions

Page 68: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 69: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 70: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

$300M

$125M + Undisc CVP$66Bn

$50M + Undisc CVP

$300M + Undisc CVP

$124M + $1.1Bn CVP

$51M + $291M CVP

$20M $379M

Page 71: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

An Eye on India and China

1.3 Bn 1.4 Bn

Page 72: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

“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…

Page 73: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 74: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 75: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 76: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 77: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

http://ois.net/category/podcast/ 64 Episodes with Over14,000 PlaysTo Date …

Tom [email protected]

Page 78: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

Save the Dates5th Annual OIS@ASCRS

New Orleans, LAMay 5th, 2016

8th Annual OIS@AAOChicago, Illinois

October 13th, 2016

HASHTAG: #OISAAO

Page 79: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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
Page 82: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

(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)

/

Page 83: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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

Page 84: 2015 The Year in Review - OIS€¦ · 22/11/2015  · 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

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


Recommended