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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
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