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NASDAQ: CLSD
We see a world without blindness; relentless in our pursuit to
preserve and improve vision.
2CONFIDENTIAL AND PROPRIETARY |
Disclaimer
Matters discussed in this presentation may constitute forward-looking statements. The forward looking statements
contained in this presentation reflect Clearside’s views as of the date of this presentation about future events and
are subject to risks, uncertainties, assumptions, and changes in circumstances that may cause Clearside’s actual
results, performance, or achievements to differ significantly from those expressed or implied in any forward looking
statement. Although Clearside believes that the expectations reflected in the forward looking statements are
reasonable, Clearside cannot guarantee future events, results, performance, or achievements. Some of the key
factors that could cause actual results to differ from Clearside’s expectations include its plans to develop and
potentially commercialize its product candidates; Clearside’s planned clinical trials and preclinical studies for its
product candidates; the timing of and Clearside’s ability to obtain and maintain regulatory approvals for its product
candidates; the extent of clinical trials potentially required for Clearside’s product candidates; the clinical utility and
market acceptance of Clearside’s product candidates; Clearside’s commercialization, marketing and manufacturing
capabilities and strategy; Clearside’s intellectual property position; and Clearside’s ability to identify additional
product candidates with significant commercial potential that are consistent with its commercial objectives. For
further information regarding these risks, uncertainties and other factors you should read the “Risk Factors” section
of Clearside’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12,
2016, and Clearside’s other Periodic and Current Reports filed with the SEC. Clearside expressly disclaims any
obligation to update or revise the information herein, including the forward-looking statements, except as required
by law.
This presentation also contains estimates and other statistical data made by independent parties and by Clearside
relating to market size and growth and other data about its industry. This data involves a number of assumptions
and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections,
assumptions and estimates of Clearside’s future performance and the future performance of the markets in which
Clearside operates are necessarily subject to a high degree of uncertainty and risk.
3CONFIDENTIAL AND PROPRIETARY |
Exclusive and proprietary access to 17 square centimeters in the
eye: The suprachoroidal space (SCS)
Phase 3 pivotal data in uveitis expected in 2H:17
Positive Phase 2 clinical data in both retinal vascular disease
(RVO) and in ocular inflammatory disease (uveitis)
Pipeline generating important near-term milestones
Proven, successful leadership team with deep ophthalmic
expertise
Targeted Therapy for Retinal and Choroidal Disease
4CONFIDENTIAL AND PROPRIETARY |
The Clearside SCS™ injection provides access through
the suprachoroidal space to the choroid and retina
5CONFIDENTIAL AND PROPRIETARY |
High drug concentration at disease - Retains drug away from where side effects occur
Note: Percentages in the illustrations represent ratio of SCS distribution to intravitreal distribution of triamcinolone to specific tissues in an animal model.
Sclera-choroid
& outer retina
12 x
0.2%
Lens
Iris-ciliary body3%
Target
treatment
Reduce
Side
effects
New Ocular Treatment Paradigm: The SCS™ injection
Rapid vision
gain
Sustained
improvement
with fewer
injections
Consistent
Response
Improved
benefit to
risk ratio
Clearside Disease Program Objectives
Posterior Segment Anterior Segment
6CONFIDENTIAL AND PROPRIETARY |
INDICATION STUDY DRUG
U.S. EST.
PREVALENCE CURRENT STATUS
Macular edema associated
with non-infectious uveitis
(Uveitis)
Zuprata™ (CLS-TA)
Pivotal Phase 3 in
progress; data 2H:17
RVO
(retinal vein occlusion)
Zuprata™ with anti-VEGF
(Eylea®)
Phase 2 data positive;
Phase 3 initiation 1H:17
Wet AMD
(age-related macular
degeneration)
Axitinib
Pre IND meeting –
Q4:16
Retinal Vascular Disease Proprietary compound Preclinical
Orphan diseases Gene therapy Preclinical
~350K
~2.2M
~1.2M
<200K
~1.2M
Clearside’sCurrent
Programs
Clearside
CollaborationsA focused pipeline of SCS™ treatments for multiple
blinding eye diseases
7CONFIDENTIAL AND PROPRIETARY |
Macular edema outcomes Percent
≥ 20% reduction in retinal thickness 69
Retinal thickness ≤ 310 microns 56
Single suprachoroidal injection of Zuprata™ 4 mg and 0.8 mg
Randomized, masked, multi-center trial
22 subjects with macular edema associated with non-infectious uveitis
Treating Retinal Inflammation: DOGWOOD Trial
8CONFIDENTIAL AND PROPRIETARY |
• Efficacy Summary: Macular Edema Associated with Uveitis
– Improvements in BCVA observed in patients treated in both trials
– Statistically significant reduction in retinal thickness in patients treated in
the Phase 2 trial
– Duration of improvement in visual acuity of up to 6 months in Phase 1/2
trial
• Safety Summary
– No serious adverse events related to treatment
– No adverse events leading to discontinuation
– No steroid-related increase in IOP
– Only adverse events related to treatment in more than 5% of dosed
patients were cystoid macular edema, blurred or decreased vision, and eye
pain
Uveitis Phase 2 and Phase 1/2 Summary
9CONFIDENTIAL AND PROPRIETARY |
Zuprata™ + Eylea® resulted in 60% fewer injections
than Eylea alone
Suprachoroidal injection of Zuprata™ plus intravitreal Eylea® versus Intravitreal Eylea injection-only in
treatment naïve RVO patients; 46 subjects - 1:1 controlled, randomized, masked, multi-center trial
In this 3-month Phase 2 study, in the concomitant (Zuprata + Eylea) arm
Fewer patients needed additional
treatments
Showed greater improvements in visual
acuity
AND
10CONFIDENTIAL AND PROPRIETARY |
• Patients treated with Zuprata™ + Eylea® showed v. Eylea alone -
– Greater improvement of vision (in comparison with Eylea and in literature)
– Sustained efficacy
– Significantly fewer Eylea treatments
• Safety Summary
– No serious adverse events
– No adverse events leading to discontinuation
– Only adverse events seen in more than 5% of patients in Zuprata arm were
conjunctival hyperemia, eye pain, ocular hypertension and increased IOP
RVO Phase 2 Summary and Next Steps
Initiating Phase 3 program in 1H2017
NASDAQ: CLSD
We see a world without blindness; relentless in our pursuit to
preserve and improve vision.
Posterior Segment Company Showcase - Clearside Biomedical

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Posterior Segment Company Showcase - Clearside Biomedical

  • 1. NASDAQ: CLSD We see a world without blindness; relentless in our pursuit to preserve and improve vision.
  • 2. 2CONFIDENTIAL AND PROPRIETARY | Disclaimer Matters discussed in this presentation may constitute forward-looking statements. The forward looking statements contained in this presentation reflect Clearside’s views as of the date of this presentation about future events and are subject to risks, uncertainties, assumptions, and changes in circumstances that may cause Clearside’s actual results, performance, or achievements to differ significantly from those expressed or implied in any forward looking statement. Although Clearside believes that the expectations reflected in the forward looking statements are reasonable, Clearside cannot guarantee future events, results, performance, or achievements. Some of the key factors that could cause actual results to differ from Clearside’s expectations include its plans to develop and potentially commercialize its product candidates; Clearside’s planned clinical trials and preclinical studies for its product candidates; the timing of and Clearside’s ability to obtain and maintain regulatory approvals for its product candidates; the extent of clinical trials potentially required for Clearside’s product candidates; the clinical utility and market acceptance of Clearside’s product candidates; Clearside’s commercialization, marketing and manufacturing capabilities and strategy; Clearside’s intellectual property position; and Clearside’s ability to identify additional product candidates with significant commercial potential that are consistent with its commercial objectives. For further information regarding these risks, uncertainties and other factors you should read the “Risk Factors” section of Clearside’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2016, and Clearside’s other Periodic and Current Reports filed with the SEC. Clearside expressly disclaims any obligation to update or revise the information herein, including the forward-looking statements, except as required by law. This presentation also contains estimates and other statistical data made by independent parties and by Clearside relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of Clearside’s future performance and the future performance of the markets in which Clearside operates are necessarily subject to a high degree of uncertainty and risk.
  • 3. 3CONFIDENTIAL AND PROPRIETARY | Exclusive and proprietary access to 17 square centimeters in the eye: The suprachoroidal space (SCS) Phase 3 pivotal data in uveitis expected in 2H:17 Positive Phase 2 clinical data in both retinal vascular disease (RVO) and in ocular inflammatory disease (uveitis) Pipeline generating important near-term milestones Proven, successful leadership team with deep ophthalmic expertise Targeted Therapy for Retinal and Choroidal Disease
  • 4. 4CONFIDENTIAL AND PROPRIETARY | The Clearside SCS™ injection provides access through the suprachoroidal space to the choroid and retina
  • 5. 5CONFIDENTIAL AND PROPRIETARY | High drug concentration at disease - Retains drug away from where side effects occur Note: Percentages in the illustrations represent ratio of SCS distribution to intravitreal distribution of triamcinolone to specific tissues in an animal model. Sclera-choroid & outer retina 12 x 0.2% Lens Iris-ciliary body3% Target treatment Reduce Side effects New Ocular Treatment Paradigm: The SCS™ injection Rapid vision gain Sustained improvement with fewer injections Consistent Response Improved benefit to risk ratio Clearside Disease Program Objectives Posterior Segment Anterior Segment
  • 6. 6CONFIDENTIAL AND PROPRIETARY | INDICATION STUDY DRUG U.S. EST. PREVALENCE CURRENT STATUS Macular edema associated with non-infectious uveitis (Uveitis) Zuprata™ (CLS-TA) Pivotal Phase 3 in progress; data 2H:17 RVO (retinal vein occlusion) Zuprata™ with anti-VEGF (Eylea®) Phase 2 data positive; Phase 3 initiation 1H:17 Wet AMD (age-related macular degeneration) Axitinib Pre IND meeting – Q4:16 Retinal Vascular Disease Proprietary compound Preclinical Orphan diseases Gene therapy Preclinical ~350K ~2.2M ~1.2M <200K ~1.2M Clearside’sCurrent Programs Clearside CollaborationsA focused pipeline of SCS™ treatments for multiple blinding eye diseases
  • 7. 7CONFIDENTIAL AND PROPRIETARY | Macular edema outcomes Percent ≥ 20% reduction in retinal thickness 69 Retinal thickness ≤ 310 microns 56 Single suprachoroidal injection of Zuprata™ 4 mg and 0.8 mg Randomized, masked, multi-center trial 22 subjects with macular edema associated with non-infectious uveitis Treating Retinal Inflammation: DOGWOOD Trial
  • 8. 8CONFIDENTIAL AND PROPRIETARY | • Efficacy Summary: Macular Edema Associated with Uveitis – Improvements in BCVA observed in patients treated in both trials – Statistically significant reduction in retinal thickness in patients treated in the Phase 2 trial – Duration of improvement in visual acuity of up to 6 months in Phase 1/2 trial • Safety Summary – No serious adverse events related to treatment – No adverse events leading to discontinuation – No steroid-related increase in IOP – Only adverse events related to treatment in more than 5% of dosed patients were cystoid macular edema, blurred or decreased vision, and eye pain Uveitis Phase 2 and Phase 1/2 Summary
  • 9. 9CONFIDENTIAL AND PROPRIETARY | Zuprata™ + Eylea® resulted in 60% fewer injections than Eylea alone Suprachoroidal injection of Zuprata™ plus intravitreal Eylea® versus Intravitreal Eylea injection-only in treatment naïve RVO patients; 46 subjects - 1:1 controlled, randomized, masked, multi-center trial In this 3-month Phase 2 study, in the concomitant (Zuprata + Eylea) arm Fewer patients needed additional treatments Showed greater improvements in visual acuity AND
  • 10. 10CONFIDENTIAL AND PROPRIETARY | • Patients treated with Zuprata™ + Eylea® showed v. Eylea alone - – Greater improvement of vision (in comparison with Eylea and in literature) – Sustained efficacy – Significantly fewer Eylea treatments • Safety Summary – No serious adverse events – No adverse events leading to discontinuation – Only adverse events seen in more than 5% of patients in Zuprata arm were conjunctival hyperemia, eye pain, ocular hypertension and increased IOP RVO Phase 2 Summary and Next Steps Initiating Phase 3 program in 1H2017
  • 11. NASDAQ: CLSD We see a world without blindness; relentless in our pursuit to preserve and improve vision.

Editor's Notes

  1. Hello, My name is Daniel White, President and CEO of Clearside Biomedical. Today, I want to present an awesome opportunity for YOUR clients to invest NOW in an IPO. Clearside is a late stage ophthalmic pharmaceutical company with a proven platform to treat diseases of the eye that lead to blindness . Our IPO can be ideal for YOUR clients to invest prior to some transformative clinical events in second and third quarter of 2016. Action: Invest Now Emotion: Save blindness
  2. There are 6 reasons YOU want to invest in Clearside Biomedical We have proprietary access We have substantiating clinical data in a pipeling of treatments for multiple blinding diseases that make up multi billion markets Multi billion dollar markets Our most advanced program…. We have significant clinical events…. We are a proven, successful management team
  3. But the real story…. Unlike other drug delivery methods, anytime you inject a drug into thie SCS , you change the distribution favorable to disease that affects the retina and choroid. An unlike other ocular drug delivery methods, SCS injection retains drug away from the areas of the delicate anterior tissues of the eye where side effects may occur.
  4. Hello, My name is Daniel White, President and CEO of Clearside Biomedical. Today, I want to present an awesome opportunity for YOUR clients to invest NOW in an IPO. Clearside is a late stage ophthalmic pharmaceutical company with a proven platform to treat diseases of the eye that lead to blindness . Our IPO can be ideal for YOUR clients to invest prior to some transformative clinical events in second and third quarter of 2016. Action: Invest Now Emotion: Save blindness