CURRENT ISSUES IN EYECARE

LTHT MEDICINE FOR MEMBERS' EVENT

10TH OCTOBER 2016

Bernie Chang

Consultant Ophthalmic, oculoplastics, lacrimal and orbital surgeon,

Lead Clinician,

Leeds Teaching Hospitals NHS Trust,

Visiting Professor of Ophthalmology, UNIMAS,

Senior Vice President

Chair of Professional Standards

RCOphth.

THANK YOU FOR THE INVITATION

Timetable:

1) Age-related macula degeneration (AMD) and

diabetic eye disease

2) Modern cataract surgery: isn't it laser?

3) Issues in eyecare delivery- perspective of The

Royal College of Ophthalmologists

NORMAL

AMD

WET AMD

DISCIFORM SCAR

TESTS: :LOGMAR CHART

TESTS: FLUORESCEIN ANGIOGRAM (ICG)

OCT

TREATMENT OF WET AMD

Dosing through Week 48Modified quarterly dosing

through Week 92#

Multi-center, active controlled, double

masked trial

VIEW 1 N=1217; VIEW 2 N=1240

0.5 mg q4 wks

(0.5q4)

2 mg q4 wks

(2q4)0.5 mg q4 wks

(Rq4)

Patients randomized 1:1:1:1

Primary endpoint:

Maintenance of Vision

Key secondary endpoint:

Mean change in BCVA

VEGF Trap-Eye (VTE) Ranibizumab (RBZ)

2 mg q8 wks*

(2q8)

*After 3 initial monthly doses# With additional evaluation visits

Study Design

VIEW STUDIES: PATIENTS GAINING

≥15 LETTERS AT 52 WEEKS

Compared to baseline; LOCF; full analysis set; Rq4 n=595; 2q4 n=613; 0.5q4 n=597; 2q8 n=607;

0.5q4

VEGF Trap-Eye

Case 1 - LA

M1

VA 59 letters (0.25)

1mm CSF = 365µm

M3

VA 71 letters (0.5)

1mm CSF = 255

M5

VA 65 letters

1mm CSF = 356

M11

VA 67 letters

1mm CSF = 349

Aflibercept solution for injection is recommended as an option for treating wet

age-related macular degeneration only if:

- Visual acuity is between 6/12 and 6/96 (0.5 to 0.06)

- No permanent damage to the fovea

- Evidence of progression

- Treatment should be stopped if a person's vision gets worse

- Manufacturer provides drug in accordance with patient access scheme

WHAT’S NEW: OCT ANGIO

DIABETIC RETINOPATHY

TREATMENT

WHAT’S NEW: INTRAVITREAL INJECTIONS (AGAIN)

STUDY DESIGN

Patients randomised 1:1:1

Primary endpoint:

Week 52

Primary endpoint:

Mean change in BCVA from baseline

Continued treatment through Year 3

Randomised, multicentre, double-masked trials

in patients with clinically significant DMO

with central involvement and ETDRS BCVA 20/40 to 20/320

N=404 (VIVID) N=461 (VISTA)

Aflibercept2 mg q4 weeks

Laser photocoagulation*

Aflibercept2 mg q8 weeks†

Secondary endpoints included:

Proportion of eyes that gained ≥10/≥15 letters

Proportion of eyes with a ≥2-step improvement in

ETDRS DRSS score

*Focal or grid laser; †After 5 initial monthly doses. BCVA, best corrected visual acuity; DMO, diabetic macular oedema; DRSS, diabetic retinopathy severity scale; ETDRS, Early Treatment Diabetic Retinopathy Study.

Korobelnik J-F et al. Ophthalmology 2014; Epub ahead of print.

PROPORTION OF PATIENTS GAINING ≥15 LETTERS

FROM BASELINE TO 100 WEEKS

*P<0.0001 vs. laser. VIVID: Laser: n=132; 2q4: n=136; 2q8: n=135; VISTA: Laser: n=154; 2q4: n=154; 2q8: n=151.Full analysis set; last observation carried forward. 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks.

Korobelnik J-F et al. Ophthalmology 2014; Epub ahead of print. Bayer HealthCare Data on File EYLD010. Bayer HealthCare Data on File EYLD014.

VIVIDWeek 52

VISTAWeek 100

VISTAWeek 52

VIVIDWeek 100

≥15 letters ≥15 letters ≥15 letters≥15 letters0

60

40

Pati

ents

(%

)

20

50

30

10

Laser

2q4

2q8

9.1

32.4* 33.3*

7.8

41.6*

31.1*

13.0

38.3*

33.1*

12.1

38.2*

31.1*

PROPORTION OF PATIENTS LOSING ≥15 LETTERS

FROM BASELINE TO 100 WEEKS

VIVID: Laser: n=132; 2q4: n=136; 2q8: n=135; VISTA: Laser: n=154; 2q4: n=154; 2q8: n=151. Full analysis set; last observation carried forward. 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks.

Bayer HealthCare Data on File EYLD010. Bayer HealthCare Data on File EYLD012. Bayer HealthCare Data on File EYLD014.

20

0

15

10

Pati

ents

(%

)

5

Laser

2q4

2q8

2.2

12.9

1.5

9.1

0.6 0.7

9.7

3.2

0.7

10.6

0.7 0.0

VIVIDWeek 52

VISTAWeek 100

VISTAWeek 52

VIVIDWeek 100

≥15 letters ≥15 letters ≥15 letters≥15 letters

M0, 47 letters

(O.2)

M1, 68 letters

(0.5)

M2, 77 letters

CATARACT SURGERY

CLOUDY LENS

IN THE PAST

PHACOEMULSIFICATION (ULTRASOUND)=

SMALL INCISION, NO STITCHES

WHAT’S NEW: YES. ITS LASER

WHAT’S NEW: LASER

V

I

D

E

O

INTRAOCULAR LENS IMPLANT

WHAT’S NEW: LENSES

CURRENT ISSUES: THE BIGGER

PICTURE/CHALLENGES

LOW ON HEALTH AGENDA

NO RATIONING IN LEEDS

HOW DO WE IMPROVE CAPACITY

WITHOUT INCREASE IN BUDGET OR

WORKFORCE?

18 WEEKS- GOOD OR BAD?

WHAT ABOUT EXISTING PATIENTS?

ROLE OF AN ACADEMY IN LEEDS

ST GEORGE'S HOSPITAL MIDDLETON

THANK YOU