CLSD Clearside Biomedical Inc

 

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): October 09, 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:

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. ☐

 

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Item 7.01 Regulation FD Disclosure.

On October 9, 2024, Clearside Biomedical, Inc. (the “Company”) will give a presentation describing its positive topline results from ODYSSEY, the Company’s Phase 2b clinical trial of CLS-AX for the treatment of wet AMD. The live and archived webcast may be accessed on the Company’s website under the “Investors” section. A copy of the presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in, or that can be accessed through, the Company’s website is not a part of this filing.

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and 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 liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On October 9, 2024, the Company issued a press release announcing the topline results from the ODYSSEY Phase 2b clinical trial. The full text of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

	Exhibit
	Number			Exhibit Description
99.1				Corporate Presentation, dated October 9, 2024.
99.2				Press Release, dated October 9, 2024.
104				Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

 

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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.

			Clearside Biomedical, Inc.
Date:	October 9, 2024	By:	/s/ Charles A. Deignan
			Charles A. Deignan Chief Financial Officer

 

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ODYSSEY Phase 2b Clinical Trial Results October 9, 2024 Exhibit 99.1

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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. These forward looking statements include statements regarding the clinical development of CLS-AX, the timing of correspondence with regulatory authorities, and the trial design features of a potential Phase 3 trial. 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, , Clearside’s Quarterly Report on Form 10-Q filed with the SEC on August 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. 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

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CLS-AX Now Phase 3 Ready Based on Positive ODYSSEY Data in Wet AMD Enrolled Only Difficult-to-Treat Participants with Active Disease Achieved Primary Outcome Maintaining Stable BCVA with Repeat Dosing Compelling Intervention-Free Rates Abbreviation: Wet AMD = neovascular age-related macular degeneration; BCVA = Best Corrected Visual Acuity Positive Safety Profile with Repeat Dosing Preliminary Topline Results Subject to Change

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Delivering on the Potential of the Suprachoroidal Space Proven Leader in Suprachoroidal Delivery with Thousands of Injections Performed in the Clinic Validated Suprachoroidal Space (SCS) Delivery with Approved Product, Multiple Collaborations, and Comprehensive IP Portfolio Differentiated SCS Clinical Program Targeting Multi-Billion Dollar Wet AMD Market 4

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Abbreviations: UME = uveitic macular edema; DME = diabetic macular edema; DR = diabetic retinopathy; Sources: Clearside data on file | 1Kurup, et. al, Macula Society 2021 Safety of the Suprachoroidal Injection Procedure Utilizing SCS Microinjector® across Three Retinal Disorders. Well-accepted by retinal physicians with thousands of injections performed to date Multiple clinical trials with 4 potential therapies in 5 indications: Wet AMD, UME, DME, DR, Choroidal Melanoma Safety profile of SCS Microinjector comparable to intravitreal injections1 SUPRACHOROIDAL SPACE INJECTION Novel SCS Microinjector® shows a demonstrated ability for precise delivery into the suprachoroidal space 30-gauge needle equivalent to most commonly used intravitreal injections Smaller than tyrosine kinase inhibitor (TKI) competitors in development SCS Microinjector®: Drug/Device Combination with Proven Versatility First and Only FDA-approved SCS product

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CLS-AX for the Treatment of Wet AMD 6

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Leveraging a Highly Potent Pan-VEGF Inhibitor with Suprachoroidal Delivery Axitinib High potency TKI with pan-VEGF receptor inhibition Proprietary CLS-AX Small Molecule Suspension Formulation Clearside formulation expertise Delivery via SCS Microinjector® Utilizes the same administration device as FDA-approved product XIPERE® 01 02 03 CLS-AX

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A large and growing market opportunity Age-Related Macular Degeneration (AMD) is a Multi-Billion Dollar Market Sources: 1 Pennington, Katie L and DeAngelis, Margaret M, Eye and Vision, Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors, Dec 22, 2016. 2 Prall, F Ryan and Ciulla, Thomas A, Medscape: Exudative (Wet) Age-Related Macular Degeneration (AMD), June 16, 2022. 3 Annual financial reports from Regeneron Pharmaceuticals, Inc. and Genentech/Roche. ~10% patientsprogress to wet AMD2 11 million U.S. AMD Patients1 170 million AMD patients worldwide1 170 million 11 million 10% AMD causes a progressive loss of central vision and is the most common cause of blindness in individuals over age 551 U.S. prevalence expected to increase to 22 million by the year 20501 Global prevalence expected to increase to 288 million by the year 20401 Current treatments require frequent injections and subset of patients experience disappointing visual outcomes2 Over $12 Billion Market and Growing3

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Positioning CLS-AX for Real-World Success *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 Maintain Vision & Reduce Office Visits Objective is to maintain visual acuity and reduce the number of injections; therefore, reducing the number of office visits Reduced treatment burden benefits patients, caregivers and payors with improved outcomes Ability to Re-dose Wet AMD is a chronic disease requiring ongoing treatment Goal is a label that allows re-dosing comparable to VABYSMO® and EYLEA HD® in the real-world setting Extend Duration Over Currently Approved Drugs 2x - 4x/year maintenance dosing for CLS-AX compared to approved drugs on label*: LUCENTIS®: 12x/year VABYSMO®: 3x - 12x/year EYLEA®: 6x – 12x/year EYLEA HD®: 3x - 6x/year

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Phase 2b Topline Data Summary 10

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ODYSSEY Phase 2b Clinical Trial Trial Objectives: Evaluate safety, efficacy & duration of CLS-AX in participants with wet AMD Primary Outcomes: Mean change in BCVA from Baseline to Week 36; Safety & tolerability Secondary Outcomes: Other changes in visual function and retinal imaging, including CST; Need for supplemental treatment; Treatment burden as measured by total injections Treatment experienced participants with reading center confirmation of persistent active disease Protocol requires re-dosing with CLS-AX in study arm Participants receive at least 2 doses of CLS-AX Provides important data to plan Phase 3 in chronic disease Participant Profile: 60 total with 2:1 randomization (40 in CLS-AX arm & 20 in aflibercept arm)

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* 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^ ODYSSEY Trial Design Required CLS-AX dose (if not given prior) #Participants can be re-dosed with CLS-AX up to every 12 weeks; All arms are sham controlled 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

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CLS-AX Demonstrated Positive Efficacy Data in Wet AMD Preliminary Topline Results Subject to Change Abbreviations: CST=Central Subfield Thickness Injection frequency reduction calculated by the average number of treatments 24 Weeks prior to Screening Visit as compared to Average number of treatments up to 24 Weeks after Baseline Visit. Overall Achieved Primary Outcome in participants with confirmed active disease BCVA Stable BCVA throughout the trial Measured as mean change in BCVA from baseline to Week 36 CST Stable CST throughout the trial Measured as mean change in CST from baseline to Week 36 Durable Effect 67% of participants did not require any additional treatment for up to 24 weeks (6 months) Injection frequency reduced by nearly 84% up to 24 weeks

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Intervention–Free Rates By Week Up to Each Visit Two-Thirds of Participants Dosed with CLS-AX Reached Six Months Without Additional Treatment Calculation accounts for missed treatments; time of initial administration of study drug shown as month 0 on figure. Intervention-free rate calculation: if participant received intervention at a study visit, those were reflected in the count at the following study visit. Week 12: 40/40 (100%) Week 16: 35/39 (89.7%) Week 20: 30/37 (81.1%) Week 24: 26/39 (66.7%) Preliminary Topline Results Subject to Change

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CLS-AX Demonstrated A Positive Safety Profile Preliminary Topline Results Subject to Change Safety Profile Excellent safety profile through 36 weeks including after mandatory re-dosing of CLS-AX at Week 24 No Serious Adverse Events (SAEs) No ocular SAEs or treatment-related SAEs: No drug or procedure related ocular SAEs
No reported drug or procedure related systemic SAEs No endophthalmitis No retinal vasculitis Positive Adverse Event (AE) Profile Ocular AEs were considered clinically mild in both arms Only one reported incident related to mild eye pain out of 84 total CLS-AX injections (1.2%) Discontinuation Rates Similar discontinuation rates between treatment and comparator groups

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Phase 2b Trial Participant Characteristics 16

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ODYSSEY Trial Focused on Participants with Active Disease Criteria for Supplemental Treatment Dosing Regimen Key Inclusion Criteria Disease Activity Assessments (DAA) Diagnosed with neovascular AMD (wet AMD) within 36 months of screening History of 2 to 4 anti-VEGF treatments in 6 months before screening and response to prior anti-VEGF treatment for wet AMD Reading center confirmation of persistent active disease; BCVA of 20 to 80 letters# Monthly DAA: Weeks 12 through 32 in both arms to determine if there is need for supplemental treatment Supplemental treatment criteria: Decrease in BCVA, increase in CST, or new or worsening vision-threatening hemorrhage due to wet AMD BCVA reduction of >10 letters from Baseline measurement Increase in CST of >100 microns on SD-OCT from Baseline measurement BCVA reduction of > 5 letters from Baseline measurement AND increase in CST of >75 microns on SD-OCT from Baseline measurement Presence of new or worsening vision-threatening hemorrhage Aflibercept is dosed via intravitreal injection (IVT); CLS-AX is dosed via suprachoroidal injection. # Using the Early Treatment Diabetic Retinopathy Study (ETDRS) measurement. Abbreviations: SD-OCT (Spectral Domain Optical Coherence Tomography). Participants in both arms received 3 aflibercept (2 mg) loading doses (2nd dose = Baseline visit) CLS-AX arm received one dose of CLS-AX (1.0 mg) at Baseline visit Unless DAA required more frequent dosing, CLS-AX arm dosed at least every 24 weeks & aflibercept arm dosed every 8 weeks

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Rapid Enrollment Demonstrates Investigator Interest in Suprachoroidal TKI Delivery Study Activity Date First Participant Randomized July 12, 2023 Last Participant Randomized December 13, 2023 SITES ACTIVATED PARTICIPANTS SCREENED PARTICIPANTS RANDOMIZED 32 60 158 Preliminary Topline Results Subject to Change Disposition CLS-AX Aflibercept Overall Enrolled, n 158 Randomized, n 40 20 60 Completed, n (%) 24 weeks 36 weeks* 39 (97.5) 36 (90.0) 19 (95.0) 17 (85.0) 58 (96.7) 53 (88.3) Required Independent Reading Center Confirmation of Active Disease *Discontinuation rate was similar between arms

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Demographics and Baseline Characteristics Characteristics CLS-AX Aflibercept Overall No. of participants 40 20 60 Mean age (range), years 76.9 (51-90) 80.3 (54-96) 78.0 (51-96) Women, no. (%) 25 (62.5) 14 (70.0) 39 (65.0) Race, no. (%) White Asian 37 (92.5) 3 (7.5) 20 (100) 0 57 (95.0) 3 (5.0) Median duration of wet AMD diagnosis (range), months 9.65 (1.4-31.1) 10.2 (1.4-20.8) 9.9 (1.4-31.1) Mean BCVA (range) at screening, ETDRS letters 69.1 (37-80) 69.1 (51-80) 69.1 (37-80) Mean CST (range) at screening, µm 266.8 (175-378) 294.3 (209-592) 276.0 (175-592) Mean Total Area of CNV (range) at screening, mm2 6.8 (1.6-26.9) 6.5 (0.5-20.8) 6.7 (0.5-26.9) Bilateral wet AMD, n 17 6 23 Mean annualized number of prior wet AMD treatments(injections/year) a (range) 9.5 (3.2-17.2) 9.2 (4.1-17.2) 9.4 (3.2-17.2) Abbreviations: AMD = age-related macular degeneration; BCVA = best corrected visual acuity; CNV = choroidal neovascularization; CST = central subfield thickness; ETDRS = Early Treatment Diabetic Retinopathy Study. aAnnualized number of prior wet AMD treatments defined as the total number of prior wet AMD treatments divided by the duration of wet AMD diagnosis in years. Preliminary Topline Results Subject to Change

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Phase 2b Topline Data Results 20 Preliminary Topline Results Subject to Change

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ODYSSEY Confirmed the Ability to Administer Multiple Doses of CLS-AX with a Well-Tolerated Safety Profile Multi-Dosing Data CLS-AX Doses Received Including Baseline # Doses # Participants % of total enrolled (n=40) 1 2 5% 2 32 80% 3 6 15% Of the 40 participants in the trial: 32 received two doses of CLS-AX and 6 received three doses of CLS-AX Preliminary Topline Results Subject to Change

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Stable Best Corrected Visual Acuity (BCVA) Over 36 Weeks ^Study drug administration for aflibercept participants given at Weeks 12, 20 and 28. Abbreviations: BCVA = best corrected visual acuity; SEM = standard error of the mean. P-value based on a 2-sample t-test between treatment groups . BCVA Within 2 Letters From Baseline at Both Week 24 and Week 36 in CLS-AX Arm Preliminary Topline Results Subject to Change CLS-AX results do not include supplemental therapy with aflibercept

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Stable Central Subfield Retinal Thickness (CSRT) Over 36 Weeks as Verified by Independent Reading Center ^Study drug administration for aflibercept participants given at Weeks 12, 20 and 28. Abbreviations: CSRT = central subfield retinal thickness – as reported by the reading center; SEM = standard error of the mean. P-value based on a 2-sample t-test between treatment groups . CLS-AX Demonstrates Stable Anatomical Control and Reduces Fluctuation Preliminary Topline Results Subject to Change CLS-AX results do not include supplemental therapy with aflibercept

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More Participants May Have Been Intervention Free at Every Time Point if DAA Criteria Strictly Applied DAA = Disease Activity Assessment. Actual treatments compared to reading center confirmation. Active disease-free rate calculation: if participant had active disease at a study visit, those were reflected in the count at the following study visit. N = number of participants assessed at a study visit; n = number of participants active disease-free up to a visit. Active disease presence based on BCVA and CSRT as graded by the central reading center. No Participants Met the DAA Criteria Per Reading Center Confirmation at Week 24, but They Received Mandatory Re-Dosing Per the Protocol Based on disease activity Week 12: 40/40 (100%) Week 16: 37/39 (94.9%) Week 20: 32/37 (86.5%) Week 24: 30/38 (78.9%) Preliminary Topline Results Subject to Change

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24 Weeks Before and After CLS-AX Consistently Reduced the Frequency of Injections Comparison of Wet AMD Treatments Pre- and Post- Randomization Injection post Baseline includes re-dosing with CLS-AX and/or supplementary treatment with aflibercept. Injection frequency reduction calculated by the average number of treatments 24 Weeks prior to Screening Visit as compared to average number of treatments up to 24 Weeks after Baseline Visit. Preliminary Topline Results Subject to Change Average number of treatments 24 Weeks prior to Screening Visit: 2.95 injections Average number of treatments up to 24 Weeks after Baseline Visit: 0.475 injections Reduced injection frequency by 84%

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CLS-AX Demonstrated Positive Safety Profile Abbreviations: AE = adverse event; SAE = serious adverse event; TEAE = treatment-emergent adverse event. No Ocular SAEs and No Treatment-Related SAEs Preliminary Topline Results Subject to Change No drug or procedure-related ocular SAEs No reported drug or procedure-related systemic SAEs No endophthalmitis No retinal vasculitis Four cases of intraocular inflammation all deemed clinically mild by the Safety Review Committee Two cases had minimal clinical signs that resolved Two cases were potentially related to drug administration In all four cases, the inflammation was no longer detected at or before Week 36

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Phase 3 Planning 27 Phase 3 plans are in development and subject to change

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CLS-AX Flexible Dosing of a Biologic with the Duration of a TKI NDA = New Drug Application Goal for Label: Flexible Wet AMD Maintenance Dosing Regimen Between 3 Months and 6 Months *Phase 3 plans are in development and subject to change Next Steps Continue analysis of ODYSSEY results including expert assessments Conduct End-of-Phase 2 meeting with U.S. FDA in early 2025 Phase 3 Current Planning Considerations Design Phase 3 to produce data supportive of a label with dosing between 3 – 6 months to align with wet AMD treatment approach desired by most retinal physicians Repeat CLS-AX dosing data in ODYSSEY will inform the Phase 3 design and improve overall data to support NDA submission Likely Trial Design Features* Two Phase 3 studies with aflibercept 2 mg as comparator Treatment-naïve participants Consistent with aflibercept high dose and faricimab Phase 3 trials As a group, not considered as difficult to treat by most retinal physicians Non-inferiority and flexible dosing design Similar to recently approved intravitreal wet AMD therapies Provides easy transition to real-world clinical setting for commercial success

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Results Summary 29

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CLS-AX Now Phase 3 Ready Based on Positive ODYSSEY Data Preliminary Topline Results Subject to Change ✔︎ ✔︎ ✔︎ ✔︎ Achieved Primary Objective: Stable BCVA to Week 36 Difficult-to-treat Wet AMD participants with confirmed activity Compelling injection free rates up to 6 months Injection frequency reduced by nearly 84% Positive safety profile No ocular SAEs or treatment-related SAEs CLS-AX was well-tolerated after re-dosing Only Phase 2 trial in wet AMD with repeat TKI dosing data to better inform and potentially de-risk Phase 3 design

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Roger A. Goldberg, MD, MBA Bay Area Retina Associates

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Nasdaq: CLSD TM

 

Clearside Biomedical Announces Positive Topline Results from ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD
Achieving All Primary and Secondary Outcomes
 

- Maintained Stable Visual Acuity and Anatomical Control Over 9 Months -

- Positive Safety Profile with No Ocular or Treatment-Related Serious Adverse Events -

- 67% of CLS-AX Participants Did Not Require Any Additional Treatment up to 6 Months -

- Reduced Treatment Burden by 84% Over 6 Months -

- Webcast and Conference Call Today at 8:00 A.M. ET with Management and
Key Opinion Leader and Board-Certified Retinal Specialist, Roger Goldberg, M.D., MBA -

 

ALPHARETTA, Ga., October 9, 2024 -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that the ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD) achieved both its primary and secondary outcomes. In participants who received CLS-AX delivered suprachoroidally, best corrected visual acuity (BCVA) and ocular anatomy (central subfield thickness) were stable up to 6 months compared to participants who received aflibercept. In addition, CLS-AX demonstrated a well-tolerated safety profile to Week 36 inclusive of mandatory re-dosing of CLS-AX at Week 24.

 

“We are very excited to report positive topline data from our successful ODYSSEY Phase 2b trial,” said George Lasezkay, PharmD, JD, President and Chief Executive Officer, Clearside Biomedical. “These encouraging results strongly support advancing our CLS-AX wet AMD program into Phase 3 development and provide further evidence of the potential benefits of delivering medicines to the back of the eye using our proprietary SCS Microinjector®. We achieved our primary outcome of maintaining stable BCVA throughout the trial as measured by the mean change in BCVA from baseline to Week 36. CLS-AX consistently reduced the frequency of injections after the initial dose of CLS-AX with approximately 90% of CLS-AX participants not requiring any additional treatment up to 4 months, 81% not requiring any additional treatment up to 5 months, and 67% not requiring any additional treatment up to 6 months before mandatory re-dosing at Week 24. We believe this data supports our goal to potentially provide a safe, convenient wet AMD treatment

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option with the advantage of a flexible maintenance dosing regimen between 3 to 6 months. We look forward to continuing to analyze the results and share additional data analysis with the retina community at upcoming medical meetings.”

 

Victor Chong, M.D., MBA, Chief Medical Officer of Clearside, added, “CLS-AX demonstrated extended duration and stable vision and anatomic measures throughout the trial in a difficult-to-treat patient population with reading center confirmed active disease early in their treatment journey. ODYSSEY confirmed the ability to administer multiple doses of CLS-AX from 12 weeks up to 36 weeks with a well-tolerated safety profile. We believe the ability to deliver multiple doses as needed between 12 and 36 weeks is a key differentiator from other treatments in development. In the trial, we observed that CLS-AX, delivered into the suprachoroidal space using our SCS Microinjector®, can be flexibly dosed similar to current biologic treatments, but has the potential to last longer because it is a highly potent tyrosine kinase inhibitor that achieves pan-VEGF blockade. Our goal is to provide a new and important treatment option with meaningful efficacy, safety, and delivery benefits for patients and retina specialists. These topline results provide valuable data in wet AMD with repeat dosing data to better inform our planned Phase 3 program design.”

 

David M. Brown, M.D., Director of Research, Retina Consultants Houston, commented, “These data are encouraging and demonstrate that suprachoroidal CLS-AX may have sustained durability beyond our currently approved agents. The positive safety profile, potential flexible dosing and delivery of CLS-AX directly to the back of the eye via Clearside’s SCS Microinjector has the potential to improve the treatment landscape for patients and physicians looking for a long-acting treatment for wet AMD.”

 

ODYSSEY Topline Data Summary

 

ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week, Phase 2b clinical trial in participants with wet AMD previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. A total of 60 participants were treated for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX was administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept was administered via intravitreal injection. Participants in the trial were determined to have active disease with a median duration of wet AMD diagnosis of 9.9 months. Eligible participants underwent diagnostic imaging at their screening visit, followed by masked reading center confirmation of persistent active disease.

 

 

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Primary and Secondary Outcomes

The ODYSSEY trial achieved its primary and secondary outcomes including the mean change from baseline in BCVA, changes from baseline in visual function and ocular anatomy, the need for supplemental treatment, treatment burden as measured by total injections over the trial duration, and safety measures.

 

CLS-AX Efficacy Results

 

CLS-AX Durability Results

 

CLS-AX Safety and Tolerability Results

 

Conference Call & Webcast Details

 

Clearside will host a webcast and conference call with accompanying slides today at 8:00 A.M. ET, including comments by management and key opinion leader Roger Goldberg, M.D., MBA, who is a board-certified retinal surgeon at the Bay Area Retinal Associates Medical Group. The live and archived webcast with slides may be accessed on the Clearside

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website under the Investors section: Events and Presentations. The live call can be accessed by dialing (888) 506-0062 (domestic) or (973) 528-0011 (international) and entering conference code: 494679.

 

About CLS-AX (axitinib injectable suspension)

 

Clearside is developing CLS-AX as a longer-acting therapy for the treatment of retinal diseases. CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species, and in both Phase 1/2a and Phase 2b wet AMD clinical trials in which CLS-AX was well tolerated and demonstrated a positive safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers by compartmentalizing axitinib behind the retina, thereby limiting drug exposure to the front of the eye.

 

About Age-Related Macular Degeneration (AMD)

Age-related macular degeneration causes a progressive loss of central vision and is the most common cause of legal blindness in individuals over age 55. Neovascular AMD (wet AMD) is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision, and accounts for the majority of vision loss in patients with this disorder. Approximately 11 million patients in the U.S. are living with AMD1, and about 10% of all patients with AMD have the wet form2. Current treatments require life-long, frequent injections to maintain efficacy. This treatment regimen tends to cause a treatment burden for patients resulting in reduced compliance and under-treatment leading to potentially limited outcomes. In the U.S., the total economic impact of late-stage AMD is estimated to be approximately $49 billion, with the majority of costs attributed to lower productivity related to job loss or job reduction due to the condition3.

Sources

1 Pennington, Katie L and DeAngelis, Margaret M, Eye and Vision, Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors, Dec 22, 2016.

2 Prall, F Ryan and Ciulla, Thomas A, Medscape: Exudative (Wet) Age-Related Macular Degeneration (AMD), June 16, 2022.

3 Retina International, The Socio-economic Impact of Age-related Macular Degeneration (AMD) in Bulgaria, Germany, and USA, Oct 12, 2022.

 

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About Clearside’s Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector®

 

Clearside’s patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The Company’s unique platform is inherently flexible and intended to work with established and new formulations of medications. Clearside’s patented SCS Microinjector® can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector system comprises a syringe, a custom-designed hub, and two 30-gauge hollow microneedles of varying lengths, each approximately one millimeter, optimizing insertion and suprachoroidal administration of drugs.

 

About Clearside Biomedical, Inc.

 

Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside’s SCS injection platform, utilizing the Company’s patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), recently completed a Phase 2b clinical trial, and planning for a Phase 3 program is underway. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com or follow us on LinkedIn.

 

Cautionary Note Regarding Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX (including any future clinical trials), and the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®. These statements involve risks and uncertainties that could

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cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control and other risks and uncertainties that are described in 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, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, and Clearside’s other periodic reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Investor Contacts:

Jenny Kobin

Remy Bernarda

ir@clearsidebio.com

 

Media Contact:

Emma Yang

media@clearsidebio.com

 

Source: Clearside Biomedical, Inc.

 

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v3.24.3

Document And Entity Information	Oct. 09, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 09, 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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
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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