Clearside Biomedical

What Clearside Biomedical does

Clearside Biomedical, Inc. is a Delaware-incorporated, ophthalmology-focused biopharmaceutical company that develops and commercializes therapeutics delivered into the suprachoroidal space (SCS) of the eye using its proprietary SCS Microinjector — the first and only FDA-approved device for this route of administration. The company's core technology is a 30-gauge microinjection platform that enables in-office, non-surgical, repeatable targeted drug delivery to the macula, retina, or choroid while compartmentalizing medication away from the vitreous and anterior chamber. Its first commercial product, XIPERE (triamcinolone acetonide injectable suspension), received FDA approval in October 2021 for the treatment of macular edema associated with uveitis and is commercialized by Bausch + Lomb in the United States and Canada and by Arctic Vision (as ARCATUS) across the Asia Pacific region. The pipeline is led by CLS-AX (axitinib injectable suspension), a pan-VEGF tyrosine kinase inhibitor that reported positive topline Phase 2b (ODYSSEY) results in October 2024 and is positioned as Phase 3-ready for wet AMD.

The business model is asset-light and partnership-driven: Clearside does not run a direct sales force and instead generates revenue through licensing royalties, upfront fees, and development and commercial milestone payments tied to its SCS platform and approved products. Strategic licensees include REGENXBIO (AAV gene therapy), Aura Biosciences (ocular oncology), and BioCryst Pharmaceuticals (diabetic macular edema). The company maintains ISO 13485:2016 certification for the SCS Microinjector device and holds a multi-patent portfolio with exclusivity extending into the mid-2030s. Headcount is reported at 11–50 employees and the company is headquartered in Alpharetta, Georgia.

As of late 2025 the company is in financial distress: Clearside filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the District of Delaware on November 25, 2025, suspended Nasdaq trading on December 1, 2025 (subsequently trading on OTC Pink under CLSDQ), filed Form 25 to delist on December 8, 2025, and received court approval on December 19, 2025 for bidding procedures to conduct an asset sale auction, with Health Ocean Limited designated as the stalking horse bidder.

Name

Clearside Biomedical

Legal name

Clearside Biomedical, Inc.

Website

https://clearsidebio.com

Company type

Private

Founded year

2012

Operating status

Closed

Headcount range

11–50 employees

Short description

Clearside Biomedical is a Delaware-based ophthalmic biopharmaceutical company that develops therapeutics delivered via its proprietary SCS Microinjector into the suprachoroidal space of the eye. It commercializes XIPERE through Bausch + Lomb and Arctic Vision and is now in Chapter 11 pursuing an asset sale.

Ownership category

akta.pro rank

Product category

Ophthalmic Therapeutics

NAICS

Surgical and Medical Instrument Manufacturing (339112), Pharmaceutical Preparation Manufacturing (325412), Ophthalmic Goods Manufacturing (339115)

SIC

Surgical & Medical Instruments & Apparatus (3841), Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAHAIAL

Ocular Drug Delivery Devices (Eye Droppers/Inserts)

Healthcare & Life Sciences/Medical Devices & Diagnostics/Drug Delivery Devices (Injectors, Pumps, Inhalers)

SECONDARYHLAIACAK

Ophthalmology Specialty Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

SECONDARYHLAKAKAE

Retina & Vitreous Specialists

Healthcare & Life Sciences/Specialist Medical Practice/Ophthalmology & Optometry

Keywords

• Ophthalmic drug delivery
• Suprachoroidal injection
• Retinal therapeutics
• Biopharmaceutical platform
• Macular edema treatment

Headquarters

HQ city

Alpharetta

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Product Sales (XIPERE): Revenue from commercial sales of XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use, commercialized through Bausch + Lomb in the US and Canada
2. License and Milestone Payments: Upfront fees, development and commercial milestones from licensing agreements with partners including REGENXBIO, Aura Biosciences, BioCryst Pharmaceuticals, and Arctic Vision
3. Royalty Revenue: Ongoing royalties from commercialized products under licensing agreements, including XIPERE sales by commercial partners

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Clearside Biomedical develops the proprietary Suprachoroidal Space (SCS) injection platform centered on the SCS Microinjector, a 30G needle-based device enabling targeted, in-office, non-surgical drug delivery to the back of the eye. The company's commercialized product, XIPERE (triamcinolone acetonide injectable suspension), is the first and only FDA-approved therapy delivered into the suprachoroidal space and treats macular edema associated with uveitis. The pipeline includes CLS-AX, a Phase 3-ready axitinib suspension for wet age-related macular degeneration, and the platform is licensed to partners for additional indications including gene therapy and ocular cancers.

Product overview

Clearside Biomedical is a biopharmaceutical company that has developed the SCS (Suprachoroidal Space) injection platform, centered on the proprietary SCS Microinjector device. The platform enables targeted, compartmentalized drug delivery to the back of the eye through a non-surgical in-office procedure. The first approved product is XIPERE (triamcinolone acetonide injectable suspension), a corticosteroid for suprachoroidal use to treat macular edema associated with uveitis, which received FDA approval in October 2021 and is commercialized by Bausch + Lomb in the U.S. and Canada. The company is advancing CLS-AX (axitinib injectable suspension) through Phase 3 development for wet AMD. The technology platform is being leveraged through licensing collaborations with REGENXBIO (AAV gene therapy), Aura Biosciences (choroidal melanoma), BioCryst Pharmaceuticals (avoralstat for diabetic macular edema), and Arctic Vision (XIPERE in Asia Pacific).

Differentiator

Problem solved

Functional benefit

Brands

• XIPERE: XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use - FDA-approved therapeutic for the treatment of macular edema associated with uveitis
• ARCATUS
• SCS Microinjector

Products and services

• SCS Microinjector Proprietary microinjection device that enables in-office, repeatable, non-surgical targeted delivery of therapies to the suprachoroidal space using a 30G needle. Used by ophthalmologists and retinal specialists to administer drug to the macula, retina, or choroid while compartmentalizing medication away from non-target tissues. Licensed to biopharmaceutical partners (REGENXBIO, Aura Biosciences, BioCryst Pharmaceuticals) and used as the device constituent of approved products.
• XIPERE (triamcinolone acetonide injectable suspension) FDA-approved corticosteroid suspension (triamcinolone acetonide) delivered into the suprachoroidal space via the SCS Microinjector for the treatment of macular edema associated with uveitis. First and only FDA-approved therapy for suprachoroidal administration and first therapy indicated for this condition. Commercialized by Bausch + Lomb (US/Canada as XIPERE) and Arctic Vision (Greater China, South Korea, Australia, New Zealand, India, ASEAN as ARCATUS).
• CLS-AX (axitinib injectable suspension) Proprietary suspension of axitinib, a potent pan-VEGF tyrosine kinase inhibitor, formulated for suprachoroidal administration via the SCS Microinjector. Developed for the treatment of wet age-related macular degeneration with the goal of extended injection-free durability compared to standard anti-VEGF intravitreal therapy.

Quantifiable outcome

• Up to 6 months injection-free period with CLS-AX in wet AMD patients
• +3 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• Bausch + LombcoreChannel Partner/ Reseller/ DistributorExclusive license for commercialization and development of XIPERE in the United States and Canada. Bausch + Lomb received a permanent J-Code for the product to support reimbursement by commercial insurers and government payers.
• Arctic VisioncoreChannel Partner/ Reseller/ DistributorExclusive license for commercialization and development of XIPERE (marketed as ARCATUS) in Greater China, South Korea, Australia, New Zealand, India, and ASEAN Countries.
• REGENXBIOcoreStrategic or Co-development PartnerExclusive worldwide rights to SCS Microinjector for delivery of AAV-based gene therapy to the suprachoroidal space for treatment of wet AMD, diabetic retinopathy, and certain other conditions for which anti-VEGF treatment is standard of care.
• Aura BiosciencescoreStrategic or Co-development PartnerWorldwide licensing agreement for use of SCS Microinjector to deliver proprietary drug candidates into the SCS for potential treatment of certain ocular cancers including choroidal melanoma.
• BioCryst PharmaceuticalscoreStrategic or Co-development PartnerExclusive worldwide license to use SCS Microinjector for delivery of proprietary plasma kallikrein inhibitor avoralstat for the treatment and prevention of diabetic macular edema.

Scale indicators7 records

Recent moves10 records

Expansion highlights5 records

Emerging players

• REGENXBIO: Clinical-stage gene therapy company that has an exclusive worldwide license with Clearside for use of the SCS Microinjector to deliver AAV-based gene therapies for wet AMD and diabetic retinopathy. Direct platform licensee and pipeline peer in retinal disease therapeutics.
• Aura Biosciences: Clinical-stage oncology company developing treatments for ocular cancers including choroidal melanoma using Clearside's SCS Microinjector for targeted suprachoroidal delivery. Shares the same delivery platform and complementary therapeutic focus area.
• BioCryst Pharmaceuticals: Commercial-stage rare disease company that has licensed Clearside's SCS Microinjector for delivery of avoralstat for diabetic macular edema. Platform licensee and therapeutic-area peer in ophthalmology drug delivery.

Broad incumbents

• Regeneron Pharmaceuticals: Leading biopharmaceutical company marketing Eylea (aflibercept) and Eylea HD, the dominant anti-VEGF therapies for wet AMD. Established incumbent that competes directly with Clearside's pipeline in the retinal disease space.
• Genentech (Roche): Major biopharmaceutical company marketing Lucentis, Susvimo (port delivery system for ranibizumab), and Vabysmo for wet AMD and other retinal diseases. Incumbent standard-of-care competitor in the wet AMD market that CLS-AX targets.
• Bausch + Lomb (Bausch Health): Major ophthalmology-focused pharmaceutical and medical device company that holds exclusive US/Canada commercialization rights to Clearside's XIPERE. Functions as both partner and broader ophthalmology industry incumbent with overlapping retinal disease portfolio.

Regional players

• Arctic Vision: China-based ophthalmology company that holds exclusive Asia Pacific rights to Clearside's XIPERE (branded as ARCATUS). Platform licensee with a regional focus in Greater China, South Korea, Australia, New Zealand, India, and ASEAN markets.

Direct peers

• Outlook Therapeutics: Clinical-stage biopharmaceutical company developing ONS-5010/LYTENAVA (bevacizumab-vikg) for wet AMD and other retinal indications. Direct therapeutic-area competitor targeting the same ophthalmology specialty physician audience as Clearside's CLS-AX.
• Adverum Biotechnologies: Gene therapy company developing ADVM-022 (icabtagene lentivector) for wet AMD using single-administration intravitreal injection. Competes with Clearside's SCS platform for dominance in long-duration retinal disease therapies.
• Kodiak Sciences: Clinical-stage biopharmaceutical company developing novel therapeutics for retinal diseases including wet AMD, with its ABC Platform for sustained-release anti-VEGF delivery. Directly competes with Clearside's CLS-AX in targeting reduced injection frequency for wet AMD patients.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/clearsidebio
• LinkedInlinkedin.com/company/clearside-biomedical-inc-

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds9 records

Investors12 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clearside Biomedical