false000153902900015390292024-07-242024-07-24

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 24, 2024

 

 

Clearside Biomedical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-37783

45-2437375

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

900 North Point Parkway

Suite 200

 

Alpharetta, Georgia

 

30005

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 678 270-3631

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

CLSD

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 7.01 Regulation FD Disclosure.

On July 24, 2024, Clearside Biomedical, Inc. (the “Company”) will host a virtual Suprachoroidal Delivery KOL Webinar (the “Webinar”). [A webcast of the Webinar will be available through the Events and Presentations page of the Investors section of the Company’s website.] The Webinar will include a slide presentation. A copy of this slide presentation is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

 

Number

 

Exhibit Description

99.1

 

Company Presentation.

104

 

The cover page from Clearside Biomedical, Inc.’s Form 8-K filed on July 24, 2024, formatted in Inline XBRL.

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: July 24, 2024

CLEARSIDE BIOMEDICAL, INC.

 

 

 

By:

/s/ Charles A. Deignan

Name:

Charles A. Deignan

Title:

Chief Financial Officer

 


Slide 1

Suprachoroidal Space Drug Delivery July 24, 2024 Exhibit 99.1


Slide 2

Forward-Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” or the negative of these terms and other similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Clearside Biomedical, Inc.’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, new risks and uncertainties may emerge from time to time, and 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; adverse differences between preliminary or interim data and final data; 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; Clearside's ability to expand its pipeline; developments and projections relating to Clearside's competitors and its industry; the impact of government laws and regulations; the timing and anticipated results of Clearside's preclinical studies and clinical trials and the risk that the results of Clearside's preclinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials and may not support further development and marketing approval; findings from investigational review boards at clinical trial sites and publication review bodies; Clearside's estimates regarding future revenue, expenses, capital requirements and need for additional financing; 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 Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, and Clearside's subsequent filings 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. 2


Slide 3

Agenda 01 02 03 04 05 Versatility of Suprachoroidal Delivery George Lasezkay, PharmD, JD, Clearside President & CEO Real World Use of Suprachoroidal Delivery Glenn Yiu, MD, PhD, Professor of Ophthalmology, University of California, Davis Pipeline Opportunities Victor Chong, MD, MBA, Clearside Chief Medical Officer Large Practice View of Suprachoroidal Delivery David Brown, MD, Director of Research, Retina Consultants Houston Q&A


Slide 4

GEORGE LASEZKAY, PharmD, JD Clearside President & Chief Executive Officer Versatility of Suprachoroidal Delivery 4


Slide 5

Delivering on the Potential of the Suprachoroidal Space Proven Leader in Suprachoroidal Delivery with Thousands of Injections Performed Validated Technology with Approved Product, Multiple Collaborations, and Comprehensive IP Portfolio Differentiated Clinical Program Targeting Multi-Billion Dollar Wet AMD Market with Phase 2b Trial Data Expected in Late Q3 2024 5


Slide 6

Proven Leader in Suprachoroidal Delivery Formulation Expertise Proprietary Microinjector with Significant Clinical Experience ISO Certified Commercial Scale Injector Manufacturing Capability Experience in Navigating the Drug/Device Regulatory Pathway 1st FDA Product Approved for SCS Administration Permanent CPT Code Granted for SCS Injections


Slide 7

Diverse Programs Using Clearside’s Suprachoroidal Injection Platform 1XIPERE® (triamcinolone acetonide injectable suspension), for suprachoroidal use has received U.S. FDA Approval and is being commercialized by Bausch + Lomb. 2In China, Arctic Vision is responsible for clinical development of ARCATUS™ (triamcinolone acetonide injectable suspension), formerly referred to as ARVN001, and known as XIPERE® in the U.S. Clearside Developed Programs THERAPEUTIC TYPE INDICATION IND-ENABLING PHASE 1 PHASE 2 PHASE 3 APPROVAL PARTNER Bel-Sar Viral-like Drug Conjugate Choroidal Melanoma ABBV-RGX-314 AAV Gene Therapy Diabetic Retinopathy (DR) ABBV-RGX-314 AAV Gene Therapy Wet AMD Avoralstat Plasma Kallikrein Inhibitor Diabetic Macular Edema (DME) SCS Microinjector® Partner Clinical Development Programs THERAPEUTIC TYPE INDICATION IND-ENABLING PHASE 1 PHASE 2 PHASE 3 APPROVAL PARTNER CLS-AX (axitinib): Tyrosine Kinase Inhibitor Wet AMD XIPERE® Corticosteroid (Triamcinolone Acetonide) Uveitic Macular Edema1 (U.S. & Canada) XIPERE® / ARCATUS™ Corticosteroid (Triamcinolone Acetonide) Uveitic Macular Edema2 Diabetic Macular Edema2 (Asia Pacific ex-Japan) XIPERE® / ARCATUS™ Corticosteroid (Triamcinolone Acetonide) Phase 2b ALTITUDE AAVIATE UME DME CoMpass


Slide 8

GLENN C. YIU, MD, PhD Professor of Ophthalmology, University of California, Davis Real World Use of Suprachoroidal Delivery 8


Slide 9

Jung et al., Drug Discovery Today, 2019 Naftali & Moisseiev, Pharmaceutics, 2021 Suprachoroidal Drug Delivery Accessing the suprachoroidal space Microneedle Microcatheter orbitsds.com clearsidebio.com 9


Slide 10

Suprachoroidal Drug Delivery OCT shows SCS expansion after SC injection in humans Baseline 1 mo 2 mo 3 mo Suprachoroidal Space * * * 10 Lampen et al. OSLI Retina, 2018 Yiu et al., Am J Ophthalmol, 2018


Slide 11

N = 160 patients with uveitic CME Suprachoroidally injected CLS-TA vs. sham (3:2) at day 0 & week 12 Phase 3 PEACHTREE study Uveitic ME Phase 2 TANZANITE study RVO + CME Phase 1/2 HULK study DME Phase 1/2 OASIS study nAMD Phase 1/2 HULK study DME Phase 2 TANZANITE study RVO + CME Phase 1/2 OASIS study nAMD 11 Yeh et al., Ophthalmology, 2020 Suprachoroidal Drug Delivery Suprachoroidally injected triamcinolone acetonide (CLS-TA) for uveitic ME


Slide 12

Suprachoroidal Drug Delivery IRIS study of real-world durability of suprachoroidally injected triamcinolone acetonide for uveitic ME Dates: Jan 2022 to Jun 2023 Index date: first suprachoroidal triamcinolone acetonide injection Rescue: any injectable, implanted, or topical cortical steroids Follow-up: 24 weeks Age ≥18 years Diagnosis of non-infectious UME Suprachoroidal injection of triamcinolone acetonide IRIS® Registry (Intelligent Research in Sight) linked to Komodo open-source claims data using the Datavant token to identify corticosteroid use Inclusion criteria Study Design 12 Singer, et al. Macula Society 2024. Durability with suprachoroidal injection of triamcinolone acetonide injectable suspension for uveitic macular edema and use of rescue therapy in clinical practice.


Slide 13

Suprachoroidal Drug Delivery Study demographics & comorbidities Abbreviations: DR, diabetic retinopathy; DME, diabetic macular edema; ME, macular edema; CRVO, central retinal vein occlusion; BRVO, branch retinal vein occlusion Abbreviations: SD, standard deviation * This was only evaluated in the 786 patients whose data could be linked to claims 41.8% of patients had glaucoma or ocular hypertension prior to suprachoroidal injection of triamcinolone acetonide 13


Slide 14

Suprachoroidal Drug Delivery Time to rescue with injectable / implantable corticosteroid 100% 80% 60% 40% 20% 0% Weeks IRIS data In PEACHTREE 86.5% did not require rescue therapy by week 24 *In PEACHTREE, all subjects had a second injection at week 12 * PEACHTREE trial Kaplan Meier Estimate 87.7% of eyes did not require an injected or implanted corticosteroid by week 24 14


Slide 15

Suprachoroidal Drug Delivery Types of injected / implanted rescue therapy Fluocinolone acetonide intravitreal implant (0.18mg), 0.8% Fluocinolone acetonide intravitreal implant (0.59mg), 0.8% Subtenon triamcinolone acetonide, 9.8% Dexamethasone intravitreal implant, 21.3% 15


Slide 16

Suprachoroidal Drug Delivery Time to rescue with any corticosteroid (including topical) 100% 80% 60% 40% 20% 0% Weeks Kaplan Meier estimate from IRIS data 75.4% of eyes did not require any corticosteroid by week 24 16


Slide 17

Suprachoroidal Drug Delivery Patient considerations for suprachoroidal injections High myopia or axial length Known scleral thinning History of glaucoma or hypotony History of ocular surgery (esp. trabeculectomy or glaucoma shunt) Patient Selection Sensation of “pressure wave” Longer duration of procedure Possible change in needle or injection site Patient Expectations Patient in supine position with head support Topical or subconjunctival anesthetic Povidone-iodine antiseptic Lid speculum recommended Patient Preparation 17 Wykoff CC, Avery RL, Barakat MR, Boyer DS, Brown DM, Brucker AJ, Cunningham ET, Heier JS, Holekamp NM, Kaiser PK, Khanani AM, Kim JE, Demirci H, Regillo CD, Yiu G, Ciulla TA. Suprachoroidal Space Injection Technique: Expert Panel Guidance. Retina | Image courtesy of Bausch & Lomb


Slide 18

Suprachoroidal Drug Delivery Needle lengths & injection locations Two needle lengths: 900 mm & 1,100 mm Preferred locations: Superotemporal or Inferotemporal 18 Image courtesy of Bausch & Lomb


Slide 19

Suprachoroidal Drug Delivery Suprachoroidal injection technique Hold the microinjector perpendicular to the ocular surface Ensure firm contact with sclera by maintaining a dimple throughout injection Inject slowly over 5 – 10 seconds Perpendicular Dimple Slow 19 Images courtesy of Bausch & Lomb


Slide 20

Suprachoroidal Drug Delivery Gene Therapy Drug Development for Geographic Atrophy To date, intravitreal biologics have failed in geographic atrophy (GA) Biofactory gene therapy uses retinal cells to produce biologics Intravitreal delivery: gene therapy mostly transfects transfects inner retina and non retinal cells, so would be similar to intravitreal biologics Subretinal delivery: even for wet AMD, it has been difficult for patient acceptance; therefore, may be even more difficult for GA without foveal involvement and good vision Suprachoroidal delivery: could be the preferred way to go 20


Slide 21

Conclusion Key Takeaways SCS Microinjector® enables targeted in-office delivery to the suprachoroidal space Clearside is the leader with FDA-approved product, XIPERE® (triamcinolone acetonide injectable suspension), for suprachoroidal use to treat uveitic macular edema Durability of suprachoroidally injected triamcinolone acetonide in the real-world is comparable to Phase 3 trial results, with only ~12% needing subsequent corticosteroid within 24 weeks Suprachoroidal delivery represents a new and innovative technique that has many potential applications beyond delivering steroids, including angiogenesis inhibitors and gene therapies 21 Singer, et al. Macula Society 2024. Durability with suprachoroidal injection of triamcinolone acetonide injectable suspension for uveitic macular edema and use of rescue therapy in clinical practice.


Slide 22

VICTOR CHONG, MD, MBA Clearside Chief Medical Officer Pipeline Opportunities 22


Slide 23

Benefits for Patients and Physicians Using SCS Microinjector® Delivery Enhanced Safety Much lower risk of endophthalmitis as direct contact to immune system vs intravitreal injection Injectate Flows to Back of the Eye Reduced risk of floaters, snow globe effect, or other visual disturbances No Implants or Devices in the Vitreous Can be easily re-dosed for potentially longer durability Injection Similar to Intravitreal Advanced technology requires only a few seconds longer for each injection


Slide 24

Competitive Advantage in Needle Gage Diameter 22G 25G 30G Outer Diameter of the Needle Relative to the Ocular Tissue Inner Diameter of the Needle Drug Product Passage 30G needle results in less damage to the ocular tissue wound size to the ocular tissue is >4x greater with 22G Needle >2x greater with 25G Needle Clearside SCS Microinjector® Gustavo Barreto Melo, et al. Progress in Retinal and Eye Research. “Critical analysis of techniques and materials used in devices, syringes, and needles used for intravitreal injections”. https://doi.org/10.1016/j.preteyeres.2020.100862


Slide 25

CLS-AX: Wet AMD Clinical Development Program


Slide 26

Leveraging a Highly Potent Pan-VEGF Inhibitor with Suprachoroidal Delivery Axitinib High potency TKI with pan-VEGF inhibition Proprietary CLS-AX Suspension Formulation Clearside formulation expertise Delivery via SCS Microinjector® Compartmentalization may eliminate treatment related floaters, haze, and anterior segment side effects Utilizes the same device as FDA-approved product XIPERE® 01 02 03 CLS-AX


Slide 27

Key CLS-AX Program Features Differentiated Approach to Targeting Wet AMD Utilizes the same SCS Microinjector device as FDA-approved product XIPERE Competitors’ delivery devices differ from their approved products Objective is to maintain efficacy and reduce the number of injections and required visits Reduced treatment burden benefits patients, caregivers and payors with improved outcomes Opportunity for treatments that may have longer duration of action in multi-billion-dollar market 2 - 3x/year maintenance dosing compared to approved drugs*: Re-dosing incorporated in Phase 2b design to provide insight for Phase 3 program Allowing re-dosing comparable to VABYSMO® and EYLEA HD® in real-world setting Potential CLS-AX Competitive Advantages LUCENTIS®: 12x/year | VABYSMO®: 3 - 6x/year EYLEA®: 6x/year | EYLEA HD®: 3 - 4x/year *Dosing regimens are per respective product labels | EYLEA® and EYLEA HD® are registered trademarks of Regeneron Pharmaceuticals| LUCENTIS® and VABYSMO® are registered trademarks of Genentech/Roche CLS-AX target profile: maintain visual acuity without need for retreatment for potentially up to 6 months


Slide 28

* Disease Activity Assessments (DAA): Conducted at Week 12 through 32 to determine need for supplemental treatment. # In CLS-AX arm, following 3 loading doses of aflibercept and initial dose of CLS-AX at Baseline, participants will receive CLS-AX at least every 24 weeks unless more frequently required based on DAA; if disease is active and participant is <12 weeks since last CLS-AX injection, participant receives dose of aflibercept; if disease is active and participant is >12 weeks since last CLS-AX injection, participant receives dose of CLS-AX. ^ In aflibercept arm, following 3 loading doses of aflibercept, participants will receive aflibercept on fixed dosing regimen every 8 weeks unless more frequently required based on DAA; if disease is active, participant receives dose of aflibercept. CLS-AX 1.0 mg Flexible dosing N=40 Aflibercept 2 mg Fixed dosing every 8 weeks N=20 VISIT 1 2 3 4 5 6 7 8 9 10 11 WEEK -6 -4 Day 1 4 12 16 20 24 28 32 36 + + Primary Outcome Disease Activity Assessments* Baseline 2:1 Randomization Sham Procedure CLS-AX 1.0 mg Suprachoroidal Injection (SCS) Aflibercept 2 mg Intravitreal Injection (IVT) Screening visit Required aflibercept dose every 8 weeks^ Multiple Dosing Requirement To Help Inform Phase 3 Development Program Required CLS-AX dose (if not given prior) #Participants can be re-dosed with CLS-AX up to every 12 weeks Participants can be re-dosed with CLS-AX at Weeks 12, 16, 20, if needed, based on DAA# Participants can be re-dosed with aflibercept at Weeks 16, 24, 32, if needed, based on DAA


Slide 29

ODYSSEY Phase 2b Key Differences Every patient in the CLS-AX group will be re-dosed at least once Re-dosing with CLS-AX 36 Week Treatment Duration Anticipated primary endpoint duration of Phase 3 wet AMD study based on FDA draft guidance Other longer duration therapies (other TKIs, gene therapy) need rescue with anti-VEGF Harder to implement in clinical practice as patients do not want to come in for a scan every 4 weeks as in clinical trials


Slide 30

ODYSSEY Update All participants in the study have completed 6 months of treatment Participants in the CLS-AX arm have received two doses of CLS-AX per protocol In July 2024 meeting, the ODYSSEY Safety Review Committee (SRC) reviewed masked safety data and recommended that the trial continue as planned without modifying the protocol or unmasking of the participants SRC noted that there have been no drug-related Serious Adverse Events (SAEs) in masked study treatments observed to date, including no endophthalmitis or retinal vasculitis On-track to release top-line data in late Q3 2024


Slide 31

Our Target Success Measures for ODYSSEY No drug related ocular Severe Adverse Events Majority of participants reach Week 24 without re-treatment BCVA changes from baseline similar at all visits in particular at Week 24 and Week 36 CST changes from baseline similar at all visits in particular at Week 24 and Week 36


Slide 32

Pipeline Expansion Opportunity in Geographic Atrophy


Slide 33

Pathology of Age-Related Macular Degeneration (AMD) Wong JHC et al., Front Neurosci 16: 1009599


Slide 34

Choroidal Hypoxia Theory and Choriocapillaris are Damaged First Geographic Atrophy is a Choroidal Disease Choriocapillaris endothelial cells damage with ghost vessels before any significant RPE changes Choriocapillaris (CC) vascular density is significantly lower in GA donor No meaningful differences in vascular lumen area / stroma area 1 VEGF level increased with low vascular density support the choroidal hypoxia theory 2 3 RPE = Retinal Pigment Epithelium Images modified from Sohn EH et al., Am J Path 2019: 189: 1473-80


Slide 35

Larger molecules cannot get through Bruch’s membrane So, if given intravitreally, it can only treat the RPE side Aging intensifies disease actions and even peptides might not be able to get through Small Molecule Can Access the Diseased Area of the RPE and Choroid Images modified from Hammadi et al JCM 2023, 12 (8), 2870 Bruch’s membrane


Slide 36

Suprachoroidal Administration Could Be Preferred Delivery Method Setting Distribution Deliver large molecules Deliver small molecules Gene therapy Suprachoroidal Office Posterior segment Not used Suspension RPE and Choroid Intravitreal Office Widespread in eye Standard Implant Mostly ganglion cells Subretinal Operating room Localized to treatment bleb Not used Not used Photoreceptor and RPE Systemic Home Whole body Need injection Oral Liver Images modified from Kasetty VM et al. Retinal Physician Aug 1, 2022, 19-23


Slide 37

Potential Target Product Profile (TPP) Aligns with SCS Suspension or SCS Gene Therapy Potential Advantages of Suprachoroidal Delivery in Geographic Atrophy Less invasive, in-office procedure Systemic therapy may be effective, but potential infection risks in this elderly population Local ocular therapy may have fewer adverse events Small molecules may have better efficacy than current therapies Potential to treat complement activation in both RPE and choroid Suprachoroidal suspension/gene therapy may have longer duration (3 to 6 months) Intravitreal gene therapy may not achieve efficacy Subretinal has additional risks Targeted delivery compartmentalized to the posterior segment Potentially fewer adverse events Able to reach the choroid first Fluid spreads circumferentially and posteriorly when injected within the suprachoroidal space, bathing the choroid, RPE, retina and adjacent areas with drug


Slide 38

Traditional Target Pathways for Geographic Atrophy Holz FG et al. Ophthalmology 2014, 1079-91 Choroidal perfusion Complement Genetic risk HTRA1 Mast cell microglia, macrophage Neuro protection Lipids oxidation Lipo fuscin


Slide 39

DAVID M. BROWN, MD Director of Research, Retina Consultants Houston Large Practice View of Suprachoroidal Delivery 39


Slide 40

Suprachoroidal (SCS) Timeline Intravitreal (IVT) Timeline Patient Travel: 45min round trip Exam: 15min Imaging: 15min Set-Up Anesthesia Sterile Prep (2min) Post Injection (0.5min) Injection as Percentage of Total Time: 0.57%* 5min 5min Injection (0.5 min) Injection (1.0 min) 30 sec increase in doctor’s time performing procedure Injection as Percentage of Total Time: 1.1%# IVT vs SCS Procedure Time Comparison in Optimized High-Volume Practice Patient Travel: 45min round trip Exam: 15min Imaging: 15min 5min 5min *IVT Injection as % of Total Time: 0.5 min / (45 + 15 + 15 + 5 + 5 + 2 + 0.5 + 0.5) min = 0.57% #SCS Injection as % of Total Time: 1.0 min / (45 + 15 + 15 + 5 + 5 + 2 + 1.0 + 0.5) min = 1.1%


Slide 41

Understanding wet AMD patients have variable dosing frequency requirements Aflibercept 8mg and Faricimab extension criteria are not typically used in clinical practice However, physicians are using them as a replacement of other anti-VEGF in Treat and Extend Ideal Phase 3 design for longer duration wet AMD therapy Re-treatment extension criteria closer to clinical practice Treatment naïve patients: to allow more direct comparison to established therapy Learning from Phase 3 Designs of Aflibercept 8mg and Faricimab


Slide 42

Discussion with Dr. Brown 42


Slide 43

Nasdaq: CLSD TM

v3.24.2
Document And Entity Information
Jul. 24, 2024
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Document Type 8-K
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Document Period End Date Jul. 24, 2024
Entity Registrant Name Clearside Biomedical, Inc.
Entity Central Index Key 0001539029
Entity Emerging Growth Company false
Entity File Number 001-37783
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 45-2437375
Entity Address, Address Line One 900 North Point Parkway
Entity Address, Address Line Two Suite 200
Entity Address, City or Town Alpharetta
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30005
City Area Code 678
Local Phone Number 270-3631
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Soliciting Material false
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Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol CLSD
Security Exchange Name NASDAQ

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