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Vince Anido to present at the Lazard Frères Capital Markets Life Sciences Conference on November 29, 2005 at 11:00 am EST
Transcript

Vince Anido to present at the Lazard Frères Capital Markets Life Sciences Conference

on November 29, 2005 at 11:00 am EST

Forward Looking StatementsCertain statements contained herein are “forward-looking”statements, (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements includerisks and uncertainties, actual results may differ materially from those expressed or implied by such forward looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, failure to achieve positive results in clinical trials, failure to receive market clearance from regulatory agencies, and those risks and uncertainties discussed in filingsmade by ISTA Pharmaceuticals, Inc. with the Securities and Exchange Commission.

A specialty pharmaceutical companyfocused on the development

and commercialization of uniqueand uniquely improved products for serious

diseases and conditions of the eye.

2005 Accomplishments

Launch of Vitrase

Approval and launch of Xibrom

IND for Ecabet Phase IIb – March ‘05

IND for Tobra/Pred Combo Project April ‘05

Added a strong steroid to the pipeline

Xibrom™ - Overview

Approved March 2005 for the reduction of ocular inflammation following cataract surgery Launched late Q2‘05First twice-daily (BID) ophthalmic NSAIDMore potent than existing NSAIDSExcellent safety profile

US Anti-Inflammatory Market8.6MM TRx > $400MM8.6MM TRx > $400MM

XibromXibromNSAID

Low to MidPotency Steroids

High Potency Steroids

ComboAnti-

Infectives &Steroids (3.8MM)

45%

(2.1MM)24%

(1.2MM)14%

(1.5MM)17%

Xibrom™ LaunchTargeted 10,000 ophthalmologists

Sales force deployment: +70 sales reps

“Xibrom First Experience” program: pre-launch awareness and use

Multiple presentations and publications

Phase IV activities: cystoid macular edema (CME), corneal abrasions, pain, replacement of or decrease in use of steroids

Xibrom Market NRx MS

0.0% 0.0% 0.0% 0.0% 0.4% 0.8%

3.9%4.8%4.9% 5.2% 5.5% 5.8% 5.9% 5.7%5.8%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

MRC 11/0

5MRC 1

8/05

MRC 25/0

5APR 0

1/05APR 0

8/05APR 1

5/05APR 2

2/05APR 2

9/05MAY 0

6/05

MAY 13/0

5MAY 2

0/05

MAY 27/0

5JN

E 03/0

5JN

E 10/0

5JN

E 17/0

5JN

E 24/0

5JL

Y 01/0

5JL

Y 08/0

5JL

Y 15/0

5JL

Y 22/0

5JL

Y 29/0

5AUG 0

5/05

AUG 12/0

5AUG 1

9/05

AUG 26/0

5SEP 0

2/05

SEP 09/0

5SEP 1

6/05

SEP 23/0

5SEP 3

0/05

OCT 07

/05OCT

14/05

OCT 21

/05OCT

28/05

NOV 04/0

5NOV 1

1/05

Week

MS

Xibrom NRx MSAcular LS NRx MSAcular NRx MSVoltaren NRx MSNevanac NRx MS

Xibrom

Voltaren

Acular

Acular LS

Nevanac

Xibrom vs. Competition

5 – 10%1.7%Decreased Visual Acuity

5 – 10%0%Capsular Opacity5 – 10%1.1%Increased IOP1 - 5%.3%Corneal Edema1 - 5%1.4%Ocular Discomfort

Ocular AE’s

- 63% Cleared by Day 14

- 95% Pain Free by Day 14

- 64% Cleared by Day 14

- 96% Pain Free by Day 3

InflammationClinical Results

SuspensionSolutionFormulationTIDBIDDosingNevanacXibromCriteria

Concentrations of Radioactivity in Ocular Tissues Following a Single 0.36% Topical Ocular Dose of 14C-Nepafenac

Nepafenac Penetration

0.001

0.01

0.1

1

10

0 6 12 18 24

Time (Hours)

Con

cent

ratio

n

Cornea Iris-Ciliary Body Aqueous HumorChoroid Retina

(μg/

equi

v./g

)

Concentrations of Radioactivity in Ocular Tissues Following a Single 0.36% Topical Ocular Dose of 14C-Bromfenac

Bromfenac Penetration

0.001

0.01

0.1

1

10

100

0 6 12 18 24

Time (Hours)

Con

cent

ratio

n

Cornea Iris-Ciliary Body Aqueous HumorChoroid Retina

(μg/

equi

v./g

)

Xibrom™ Launch Results

Excellent coverage of high prescribers

Solid market share gains

• +6% overall market share

• 10% market share in XFE program participants

Physicians reporting multiple uses – replacing other ophthalmic NSAIDS

Well prepared for competitive response

NSAID RX market is growing 15%

Istalol® Product Overview

Once daily beta blocker (timolol) for glaucoma

Strong patent protectionBetter penetration through corneaOther beta-blockers are gel formulations or BID solutions

Estimated U.S. market sizeGlaucoma: $1.4 billionOphthalmic beta-blockers: $165 million

Data Source: IMS

Non-Selective Beta Blocker Market

Istalol® Target Market: 4.8 MM TRx

Timolol Solutions1.5 TRx

Timolol Gels

2.2 TRxA/O

1.2 TRx

Dominated by Timolol Products: 77% (3.7MM) TRxDominated by Timolol Products: 77% (3.7MM) TRx

46%46%

23%23%

31%31%

5.1

4.6

4.1

332.8

2.52.4

2

2.5

3

3.5

4

4.5

5

5.5

Jan Feb Mar Apr May June July Aug

MS

(%)

1st 5 months = + 0.6%

Last 3 months = + 2.1%

Istalol NRx $$ MS

FDB GCN

Change

Istalol Territory Performance

% Captured by Istalol

ISTALOL + TIM SOLTIM SOLISTALOLQ2 vs Q1

22%131 10229Boston22%297 23364Los Angeles21%247 19453Orlando20%169 13534Cincinnati19%217 17542Charlotte19%482 39092Atlanta17%343 28360Minneapolis So11%237 21126Iowa

“Offender” Territories

“Offender” Territories experience:1. Significant increases in Timolol solution2. Low % captured by Istalol

Istalol® Commercial Progress

Now almost 2,000 TRXs per week and growing

4 % NRX market share

1.24 bottles of Istalol dispensed per Rx

Market is flat or declining slightly – a major change from prior years

Impact of substitution varies by territory

Strong pull through from wholesalers by pharmacies

Ovine hyaluronidase• Multiple uses• Multiple vial configurations

Estimated U.S. market size• Spreading agent: $50 million• Vitreous hemorrhage: $200 million• Diabetic retinopathy: $500 million

Uses outside of ophthalmology• Oncology• Plastic surgery• Pediatric surgery

Vitrase Product Overview

200U/ml and 6200U vials

SpreadingAgent

Mobilizes other drugsthroughout tissues

Used in OphthalmicSurgeries with anesthetics

Vitrase Lead Indication

Vitrase® ActivitiesTargeted to ophthalmic surgeons

Over 400 accounts purchasing the product regularly

Multiple Continuing Medical Education programs ongoing

Both efficacy and safety papers for vitreous hemorrhage now published in AJO

Two HCPS (J) codes for preservative-free ovine hyaluronidase established

Reimbursement activities underway with regional CMS carriers

R&D Focus

Xibrom line extensions and new uses

Expand uses of Vitrase®

Reformulations— Tobra/Pred combo, strong steroid- both for inflammation

In-licensed products, e.g., Ecabet for the treatment of dry eye

Xibrom™ R&D Program

Cystoid Macular Edema (CME) – prevention & treatment Comfort vs Acular, Acular LS, Voltaren, NevanacTreatment of Pain Associated with Corneal Ulcers Pain control with surface ablation (vs Acular LS)Prevention of pain post-selective laser trabeculoplasty (SLT) vs Acular vs steroid. Photorefractive Keratectomy (PRK) pain vs Acular LSIC 50 vs ketorolac, nepafenac, diclofenac (Japan)Pharmacokinetics vs other NSAIDSMultiple line extensions

Vitrase® Expanded Uses

Ophthalmology: PVD (diabetic retinopathy), “floaters”, combo with AMD drugsOncology : spreading agent indication“as an adjuvant to increase the absorption and dispersion of other injected drugs”Contrast Enhanced Radiation Therapy (CERT)

Tobra/Pred ComboInternally developed, IND filedProprietary, patent filed formulation thatmimics the composition of tears in aninflammed eye

Combo includes most prescribed highpotency steroid

Phase III trial – enrollment complete

NDA filing 1H’06; Launch 2007

Ecabet Sodium

Increases mucin production by conjunctival goblet cells

Mucin: a component of tear film that lubricates and retards tear evaporation

Phase IIb – Completion 2H‘05• Finalize endpoints for design of Phase

III trialsNDA filing expected in ’07-’08

Strong Steroid - Reformulation

No strong steroids launched in ophthalmology for more than a decadeNCE for ophthalmologyInternally developedIndication: inflammation/allergyPhase II 2H‘06Begin Phase III 1H’07File NDA 1H’08

Attractive Product Portfolio Profile

Increasing Reward

Dec

reas

ing

Ris

k

Ecabet Dry eye

Caprogel

Istalol

Xibrom

High Reward: Low Risk

Low Reward: High Risk

Low Reward:Low Risk

High Reward:High Risk

VitraseSpreading Agent

Vitrase Vitreous

Hemorrhage

Vitrase Diabetic

Retinopathy

Tobra/Pred

Strongsteroid

Vitrase Oncology

Financial Highlights

YTD Q3 revenues: $7 millionQ3 net loss of $9 million (lower than Q1 and Q2 and prior year)Q3 is first full quarter reflecting sales force scale up impactCurrently have $44 million in cashApproximately 26 million shares outstanding

Upcoming Drivers to SuccessXibrom, Istalol and Vitrase commercial successEcabet Phase IIb resultsTobra/Pred results and 1H ’06 NDAExpanded uses and line extensions of XibromVitrase reimbursement and expansion of usesAdditional business development opportunities


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