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Understanding

Novartis Pharmaceuticals (HK) Ltd

27/F, 1063 Kings Road

Quarry Bay, Hong Kong

Tel: (852) 2882 5222

Fax: (852) 2577 0274 HK-NOV-145a

HKC-LUC-L379-1012b

References:

1. National Eye Institute, National Institutes of Health. Facts about age-relatedmacular degeneration. Available at: www.nei.nih.gov/health/maculardegen/

armd_facts.asp. Accessed 11 September 2012.

2. WebMD. Age-related macular degeneration. Available at: www.webmd.com/

eye-health/macular-degeneration/age-related-macular-degeneration-over-view. Accessed 11 September 2012.

3. Kaiser PK, Do DV.Int J Clin Pract2007;61:501-509.

4. Mayo Clinic. Wet macular degeneration. Available at: www.mayoclinic.com/

print/wet-macular-degeneration/DS01086. Accessed 5 October 2012.

5. American Health Assistance Foundation. Macular degeneration riskfactors and prevention. Available at: www.ahaf.org/macular/about/risk.html.Accessed 5 October 2012.

6. Visudyne Packing Insert. Switzerland: Novartis; August 2002.

7. Lucentis International Package Insert. Switzerland: Novartis; June 2011.

8. Singer MA, Awh CC, Sadda S, et al.Ophthalmology 2012;119:1175-1183.

9. Rosenfeld PJ, Brown DM, Heier JS, et al. N Engl J Med2006;355:1419-1431.

10. U.S. Food and Drug Administration. FDA approves new biologic treatment for

wet age-related macular degeneration. News release; June 2006.

11. European Medicines Agency. Lucentis (ranibizumab). Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/

human/000715/WC500043548.pdf. Accessed 5 October 2012.

12. Novartis Hong Kong Website. Lucentis. Available at: www.novartis.com.hk/

tc/products/pharma_products/detail.html?id=18. Accessed 5 October 2012.

13. Hospital Authority Drug Formulatory; October 2012.

14. AMD Alliance International. Prevention and early detection. Available at: www.amdalliance.org/information_prevention.html. Accessed 5 October 2012.

15. AMD Alliance International. Available at: www.amdalliance.org/information_what_causes_amd.html. Accessed 5 October 2012.

16. Macular Degeneration Partnership. The Amsler grid. Available at: www.amd.org/living-with-amd/resources-and-tools/31-amsler-grid.html. Accessed 18

October 2012.

17. Augustin AJ, Offermann I, Lutz J, et al. Retina2005;25:443-445.

This booklet is intended for distribution by healthcare professionals.

Please consult your ophthalmologist for details.

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1 21

2

Retina

Iris

Anterior chamber

Pupil

Cornea

Ciliary body

Optic nerve

Macula

Vitreous gel

Vitreous gel

Lens

Lens

What is age-related macular

degeneration (AMD)?1-3

Deterioration of the macula

A leading cause of vision loss in people aged 60 years or older

Occurs in dry and wet forms

Dry AMD Presence of yellow deposit (drusen) in the macula

Thinning of the photoreceptor layer Most common form of AMD; approximately 90% of peoplewith macular degeneration develop the dry form

In advanced stage, patients may have a blind spot in thecentre of their vision, or even lose their central vision

May lead to wet form of AMD

Wet AMDAbnormal blood vessel growth

Blood and fluid leak into the retina,causing distortion of vision

This form causes severe vision loss

What is the macula?1,2

Central portion of the retina

Area with high photoreceptor cell density

Provides sharp, detailed central vision

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3 4

Diminished or altered perception of colour

Blurred vision in the centre of vision

Vision distorts or becomes distorted

Dark, black spot in central vision

Risk factors of AMD4,5

Age

Your risk of macular degeneration increaseswith age. About one third of adults aged 75years or older are affected by AMD

Family history of macular degeneration

If someone in your immediate familyhad AMD, you may be at higher risk ofdeveloping the disease

Gender

Women are more likely to develop AMD

than men Smoking

Smoking increases an individuals chanceof developing AMD by two- to five-fold

High blood pressure

High blood pressure leads to narrowing ofthe blood vessels that nourish the retina

High cholesterol

An elevated cholesterol level in blood is

associated with increased risk of AMD

Obesity

Severely overweight individuals are more likely tobe affected by AMD

Prolonged sun exposure

High exposure to sunlight and ultraviolet light is arisk factor of AMD

Symptoms of AMD1,2

May not have symptoms in early stage

A dim, blurred spot in the middle of your vision

The affected area may become larger or darker over time

Diminished or altered perception of colour

Dark or blurred central vision

Difficulties in recognising faces

Straight lines appearing wavy or distorted

Blind spot in your field of vision; central vision loss

Symptoms can be on either eye or both eyes

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5 6Consult your ophthalmologist for details

If left untreated, what are the

consequences?

2

Wet AMD can cause an irreversible visual impairment

When both eyes are affected, you may experience asignificant decrease in your quality of life

Early treatment can help:

Delay or reduce the severity of AMD

Prevent severe vision loss

Improve vision

Early detection and treatment are very important

What is the treatment of AMD?1-4

There are several treatment options, including:

Photodynamic therapy

Combines the use of photo-sensitizing drug andnon-thermal laser treatment

Prevents and stops the leakage of abnormalblood vessels

Intravitreal injections

Direct injection of a drug into the eyes

Inhibits abnormal vessel growth

Laser therapy

Uses high-energy laser to treat

Destroys abnormally growing blood vessels

May affect surrounding healthy tissues

Photodynamic Therapy 2,6Mechanism: Photodynamic therapy combines the use of

photo-sensitizing drug and non-thermal laser to destroy abnormalblood vessels

Procedure:

A 10-minute intravenous infusion of Visudyne

A 5-minute waiting time for drug to reach abnormal blood vessels

A non-thermal laser is then applied to the patients eyes for83 seconds

The non-thermal laser activates the drug to destroy abnormalvessels

Precautions:

Patients should avoid direct exposure to sunlight for 48 hoursafter treatment

Long sleeves and sunglasses should be worn when outdoors.Sunblock does not prevent the strong light ef ficiently

Patients can be exposed to indoor light

In case transient visual disturbances occur after treatment,patients should not drive or operate machinery for as long as

symptoms persist

Intravitreal injections1

Mechanism:Intravitreal injection blocks vascular endothelialgrowth factor (VEGF) which leads to the growth of abnormal bloodvessels

Procedure:

Sterilization and anaesthesia of the eyes

Direct injection of an anti-VEGF drug into the eyes

Injection is performed once a month until visionbecomes stable

If left untreated, what are the

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Prevention of AMD4,5,14,15

Attend regular eye check-up

Undergo routine eye exam according to your doctorsrecommendation

Quitsmoking

Quit smoking to reduce your risk of developing AMD

Consume a balanced diet

Dietary fats and cholesterol may obstruct blood flow andincrease the risk of AMD. A low-fat diet can help maintainyour vision

Avoid excessive sun exposure

Wearing sunglasses and hats may help prevent disease

Pay attention to nutritional intake

Studies have shown that vitamins C and E, lutein, antioxidants,beta-carotene, and zinc may help delay progression of AMD.Consult your ophthalmologist for details

Manage your other diseases

Follow your doctors instruction for controlling other conditions(eg, high blood pressure, high cholesterol) to reduce the risk

of AMD

Lucentis(Ranibizumab)Efficacy3,7

More than 90% ofpatients maintain andimprove vision

Efficacy can bemaintained for up to twoyears

Improves vision-relatedquality of life

Safety3,8*

Multiple intravitrealinjections of ranibizumabwere well tolerated for4 or more years

Only a small number ofpatients suffered fromadverse events

MARINA Study

Lucentis-treatedgroup

Control group

15

10

5

0

-5

-10

-15

Numberofletters

21.5

letters

difference

Figure. Lucentis-treated patients had vision gain at 2 years

post-treatment7,9

Lucentishas been approved by international and local organizations

for the treatment of wet AMD10-13 :

Approved by the US Food and Drug Administration (FDA) in 2006

Approved by the European Union (EU) and Hong Kong HealthDepartment in 2007

Listed in Hospital Authority Drug Formulary (HADF) as treatmentfor wet AMD

* Please refer to the product information fordetails on drug safety

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VISUDYNE

Presentation: Verteporn: 15 mg, powder for solution for infusion.Indications:

Visudyne is used for the treatment of Patients with exudative (wet) age-related macular degeneration (AMD) with

predominantly classic subfoveal choroidal neovascularisation (CNV) or Patient with subfoveal choroidal neovascularisation secondary to patho-

logical myopiaDosage:Visudyne therapy is a two-step process. The rst step is a 10-min-ute intravenous infusion of Visu dyne at a dose of 6 mg/m2body surface area,diluted in 30ml infusion. The second step is the light activation of Visudyneat 15 minutes after the start of the infusion. For this, a diode laser generat-ing non-thermal red light (wavelength 689 nm 3 nm is used via a slit lampmounted bre optic device and a suitable contact lens, At the recommendedlight intensity 600 mW/cm2, it takes 83 seconds to deliver the required lightdose of 50J/cm2.Patients should be re-evaluated every 3 months and receive an additionaltreatment in the event of recurrent CNV leakage.Contraindications:

Visudyne is contraindicated for patients with porphyriaor a known hypersensitivity to verteporn or to any of the excipients of Visu-dyne.Precautions/Warnings: Patients who receive Visudyne will become pho-tosensitive for up to 48 hours after the infusion. Caution should be exercisedin patients with moderate to severe hepatic impairment or biliary obstruction.Patients who experience a severe decrease of vision (equivalent to 4 linesor more) within one week after treatment should not receive another treat-ment, at least until their vision completely recovers to pre-treatment level.

Avoid extravasation. Patients should be under medical supervision during theVisudyne infusion. Only compatible lasers should be used.Visudyne should be used in pregnant women only if the benet to the motherjusties the potential risk to t he foetus. In breast-feeding women, treatmentshould be postponed or breast-feeding interrupted for at least 48 hours. Thedecision should take into consideration the importance of the drug to themother and the consequences of breast feeding interrupti on to both the babyand the mother. Following treatment patients may develop transient visualdisturbances that may interfere with their ability to drive or use machines.Patients should not drive or use machines as long as these symptoms persist.Overdose of drug and/or light in the treated eye may result in non-selectivenon-perfusion of normal retinal vessels with the possibility of severe visiondecrease. Overdose may also result in the prolongation of the period duringwhich the patient remains photosensitive.Interactions: It is possible that concomitant use of other photosensitisingagents could increase the potential for photosensitivity reactions.

Visudyne precipitates in salin e solutions . Should not b e mixed with otherdrugs in the same solution.

Adverse reactions: Undesirable effects in clinical trials or spontaneouslyreported during post marketing surveillance include:Ocular side effects:Common effects:Abnormal vision (e.g. blurry, hazy, vision), or ashes oflight, decreased vision, visual eld defect (e.g. grey or dark haloes, scotomaand black spots). Severe vision decrease, equivalent of 4 lines or more, within7 days after treatment was rep orted in 2.1% of the verteporn treated patientsin the placebo-controlled ocular Phase III clinical studies and in less than 1%of patients in uncontrolled clinical studies. The event occurred mainly in pa-tients with occult only CNV lesions due to AMD. Partial recovery of vision wasobserved in some patients.Uncommon effects:Retinal detachment (non-rhegmatogenous), subreti-nal/retinal haemorrhage, vitreous haemorrhage.Rare effects:Retinal or choroidal vessel non-perfusion, retinal pigment epi-thelial tear.Injection site side effects:Common effects: Pain, oedema, inammation, extravasations.

Uncommon effects: Haemorrhage, discoloration, and hypersensitivity.Rare effects: Blistering.Systemic side effects:Common effects: Infusion-related pain primarily presenting as back pain,photosensitivity reaction, asthenia. Photosensitivity reactions occurred inthe form of sunburn following exposure to sunlight usually within 24 hoursof Visudyne infusion. Such reactions could be avoided by compliance withphotosensitivity protection instructions.Uncommon effects: Hypertension, hypoesthesia, fever, nausea.Rare effects:Vaso-vagal reactions and hypersensitivity reactions which onrare occasions can be severe. General symptoms can include headache,malaise, syncope, sweating, dizziness, rash, urticaria, pruritus, dyspnoea,ushing and changes in blood pressure or heart rate.Infusion related back pain and chest pain, which may radiate to other areasincluding but not limited to pelvis, shoulder girdle or rib cage.Packs:Glass vial containing 15 mg powder.Prices:Country specic.Note:Before prescribing, please read full prescribing information.

LUCENTIS

Note:Before prescribing, consult full prescribing information.Presentation:Ranibizumab. Each vial contains 2.3 mg of ranibizumab in0.23 mL solution.Indications: Treatment of neovascular (wet) age-related macular degener-ation (AMD). Treatment of visual impairment due to diabetic macular edema(DME). Treatment of visual impairment due to macular edema secondary toretinal vein occlusion (branch RVO or central RVO).Dosage:The recommended dose is 0.5 mg (0.05 mL) given as a single in-travitreal injection. Treatment is given monthly and continued until maximumvisual acuity is achieved, conrmed by stab le visual acuity for three consecu-tive monthly assessments performed while on Lucentistreatment. Patientsshould be monitored monthly for visual acuity. Treatment is resumed withmonthly injections when monitorin g indicates a loss of visual acuity due to wet

AMD, DME or macular edema secondary to RVO and continued u ntil stablevisual acuity is reached again for three consecutive monthly assessments.

The interval between two doses should not be shorter than 1 month. Lucen-tis and laser photocoagulation in DME or in branch RVO: Lucentis has beenused concomitantly with laser photocoagulation in clinical studies. When giv-

en on the same day, Lucentis should be administered at least 30 m inutes afterlaser photocoagulation. Lucentis can be administered in patients who havereceived previous laser photocoagulation. Lucentis must be administered bya qualied ophthalmologist using aseptic techniques. Broad-spectrum topi-cal microbicide and anaesthetic should be administered p rior to the injection.The patient should be instructed to self-administer antim icrobial drops fourtimes daily for 3 days before and after each injection. Not recommended inchildren and adolescents.Contraindications: Hypersensitivity to ranibizumab or to any of the excipi-ents, patients with active or suspected ocular or periocular infections, pa-tients with active intraocular inammation.Precautions/Warnings: Intravitreous injections have been associatedwith endophthalmitis, intraocular inammation, rhegmatogenous retinal de-tachment, retinal tear and iatrogenic traumatic cataract. Therefore properaseptic injection techniques must be used. Patients should be monitored dur-ing the week following the injection to permit early treatment if an infection oc-curs. Transient increases in intraocular pressure (IOP) have been seen within60 minutes of injection of Lucentis. Sustained IOP increases have also beenreported. Intraocular pressure and the perfusion of the optic nerve head mustbe monitored and managed appropriately. There is a potential risk of arterialthromboembolic events following intravitreal use of VEGF inhibitors. A numer-ically higher stroke rate was observed in patients treated with ranibizumab0.5 mg compared to ranibizumab 0.3 mg or control, however, the differenceswere not statistically signicant. Patients with k nown risk factors for stroke, in-cluding history of prior stroke or transient ischemic attack should be carefullyevaluated by their physicians as to whether Lucentis treatment is appropriateand the benet outweighs the potential risk. As with all therapeutic proteins,there is a potential for immunogenicity with Lucentis. Lucentis has not beenstudied in patients with active systemic infections or in patients with con-current eye conditions such as retinal detachment or macular hole. Thereis limited experience with treatment of patients with prior episodes of RVOand of patients with ischemic branch RVO (BRVO) and central RVO (CRVO).In patients with RVO presenting with clinical signs of irreversible ischemicvisual function loss, treatment is not recommended. Should not be usedduring pregnancy unless the expected benet outweighs the potential risk tothe fetus. For women who wish to become pregnant and have been treatedwith ranibizumab, it is recommended to wait at least 3 months after the lastdose of ranibizumab before conceiving a child; use of effective contracep-tion recommended for women of child-bearing potential; breast-feeding notrecommended. Following treatment patients may develop transient visualdisturbances that may interfere with their ability to drive or use machines.Patients should not drive or use machines as long as these symptoms persist.Interactions:No formal interaction studies have been performed.

Adverse reac tions: Very common adverse reactions a re: intraocularinammation, vitritis, vitreous detachment, retinal hemorrhage, visual distur-

bance, eye pain, vitreous oaters, conjunctival hemorrhage, eye irritation, for-eign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocu-lar hyperemia, eye pruritus, intraocular pressure increased, nasopharyngitis,headache, arthralgia. Common adverse reactions are:retinal degenera-tion, retinal disorder, retinal detachment, retinal tear, detachment of the retinalpigment epithelium, retinal pigment epitheliu m tear, visual acuity reduced, vit-reous hemorrhage, vitreous disorder, uveitis, irit is, iridocyclitis, cataract, cata-ract subcapsular, posterior capsule opacication, punctuate keratitis, cornealabrasion, anterior chamber are, vision blurred, injection site hemorrhage,eye hemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photop-sia, photophobia, ocular discomfort, eyelid edema, eyelid pain, conjunctivalhyperemia, stroke, inuenza, urinary tract i nfection*, anemia, anxiety, cough,nausea, allergic reactions (rash, pruritus, urticaria, erythema). Uncommonadverse reactions are:blindness, endophthalmitis, hypopyon, hyphema,keratopathy, iris adhesions, corneal deposits, corneal edema, corneal striae,injection site pain, injection site irritation, abnormal sensation in eye, eyelidirritation. Serious adverse events related to intravitreal injections includedendophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatro-genic traumatic cataract.* observed only in the DME population

Packs and prices: Country specic.Legal classifcation:Country specic.

Self-assessment test:Amsler Grid16,17

A simple self test of AMD

Steps:

Hold the grid at a distance of 30 cm at eye level

Ensure adequate light in room If you suffer from other vision condition (eg, short

sightedness), wear your reading glasses to perform the test

Cover your left eye; with the right eye, focus on the white dotin the centre of the grid

Repeat the test covering the right eye

If there is any change in your central vision, the lines of the gridwill appear wavy or missing. Contact your ophthalmologist assoon as possible for thorough examination.