Epion Therapeutics
Epion Therapeutics is a clinical-stage ophthalmic biopharmaceutical company developing EpiSmart, a drug-device combination for minimally invasive epithelium-on corneal cross-linking to treat keratoconus, currently completing Phase 3 trials ahead of an NDA submission.
- Company typePrivate
- Founded2017
- HeadquartersBurlington, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Epion Therapeutics does
Epion Therapeutics, Inc. is a clinical-stage ophthalmic biopharmaceutical company developing EpiSmart, a drug-device combination system for minimally invasive epithelium-on (epi-on) corneal cross-linking to treat keratoconus and other ectatic corneal diseases. The company originated as CXL Ophthalmics, LLC in 2017, rebranded to Epion Therapeutics in July 2023, and is headquartered in Burlington, Massachusetts with 1–10 employees. The EpiSmart system integrates three proprietary components: EpiPrep (a disposable wand and loading sponge for epithelial drug delivery), RiboStat (a fixed-dose combination of riboflavin 0.5% and sodium iodide 0.015% that eliminates the need for supplemental oxygen and removes cytotoxic hydrogen peroxide byproducts), and a dual-head UV-A light device that enables simultaneous bilateral treatment via a proprietary light cycling protocol. The product is protected by at least 12 US and 3 European patents covering the device, drug formulation, and applicator methods.
The company completed Phase 3 Apricity clinical trials in June 2026, the largest epi-on cross-linking program to date with approximately 800 patients across 26 US sites, and was granted FDA Fast Track designation in October 2025. Backed by $50.5M in disclosed funding — including a $32M Series A led by AXA IM Alts in September 2022 and an $18.5M financing round led by OCULUS Optikgeräte GmbH in October 2025 — Epion is positioned for NDA submission and subsequent US commercialization through traditional ophthalmic channels.
Epion's go-to-market is pre-commercial: the company currently runs 26 Phase 3 investigational sites and plans to commercialize post-FDA-approval via direct sales to ophthalmologists, corneal specialists, and specialty eye clinics treating keratoconus patients aged 8 and older. The OCULUS partnership provides commercial-scale engineering, manufacturing, and a global ophthalmic distribution platform (Pentacam-installed base across Europe, Asia, and the Americas) for device production and potential international expansion. Pricing has not been disclosed, and the company does not yet generate revenue.
Epion Therapeutics firmographics
Firmographics- Name
- Epion Therapeutics
- Legal name
- Epion Therapeutics, Inc.
- Website
- https://epiontx.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Epion Therapeutics is a clinical-stage ophthalmic biopharmaceutical company developing EpiSmart, a drug-device combination for minimally invasive epithelium-on corneal cross-linking to treat keratoconus, currently completing Phase 3 trials ahead of an NDA submission.
- Ownership category
- akta.pro rank
Epion Therapeutics industry classification
Industry- Product category
- Ophthalmic medical devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845)
- akta.pro primary industry
- Cornea & External Disease Surgical Devices (Keratoplasty Tools, Cross-Linking Systems, Amniotic Membrane Delivery) (HLAHAJAK)
Keywords
Where Epion Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Burlington
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Epion Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales
Revenue model
- EpiSmart Cross-Linking System: As a late-stage clinical company, Epion does not yet generate revenue. Upon FDA approval, the company expects to commercialize its EpiSmart epithelium-on cross-linking system as a medical device pharmaceutical combination product sold to ophthalmologists and corneal specialists for keratoconus treatment.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels5 records
Epion Therapeutics product offering
Product offeringCore offering
Epion Therapeutics is developing EpiSmart, a drug-device combination system for treating keratoconus (a progressive corneal ectatic disease) using transepithelial (epithelium-on) corneal cross-linking. The system integrates three proprietary components: the EpiPrep drug delivery wand and sponge, the RiboStat riboflavin-sodium iodide formulation, and a dual-head UVA light device that enables simultaneous bilateral treatment without surgical removal of the corneal epithelium.
Product overview
Epion Therapeutics is a clinical-stage ophthalmic company developing EpiSmart, a transformative cross-linking system for treating keratoconus. The system is a drug-device combination consisting of three integrated components: EpiPrep (disposable wand and loading sponge for epithelial drug delivery), RiboStat (fixed-dose riboflavin and sodium iodide formulation), and a dual-head UVA light device. Unlike traditional epi-off cross-linking that requires surgical removal of the corneal epithelium, EpiSmart preserves the epithelium, enabling simultaneous bilateral treatment, reduced discomfort, and faster recovery. The system is currently in Phase 3 clinical trials and has received FDA Fast Track designation.
Differentiator
Problem solved
Functional benefit
Brands
- EpiSmart™: EpiSmart™ Epithelium-On Cross-Linking System is a drug-device combination designed to treat keratoconus, combining proprietary drug delivery devices, fixed-dose combination drug (RiboStat), and a patented UVA light device for simultaneous bilateral treatment.
- RiboStat™
- EpiPrep™
Products and services
- EpiSmart Epithelium-On Cross-Linking System A drug-device combination designed to treat keratoconus, a progressive corneal disease. The system combines proprietary drug delivery devices (EpiPrep), a fixed-dose combination drug (RiboStat), and a patented dual-head UVA light device to perform epithelium-on (epi-on) corneal cross-linking without disrupting the corneal epithelium. It enables simultaneous bilateral treatment, treatment at diagnosis without documented progression, and rapid return to normal activities (1-2 days).
Quantifiable outcome
- 80% of patients maintained or improved corrected distance visual acuity at 12 months post-treatment
- +5 more outcomes
Companies that use Epion Therapeutics
Customer profileSegments3 records
Ideal customer profiles2 records
Epion Therapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Epion Therapeutics partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- OCULUS Optikgeräte GmbHcoreOCULUS partnered through an $18.5M financing round and strategic partnership. OCULUS is a world leader in ophthalmic and optometric devices including the Pentacam, the gold standard for keratoconus detection. OCULUS will apply its engineering expertise to development and manufacturing of the EpiSmart UVA therapeutic device. OCULUS operates 12 subsidiaries across Europe, Asia, and the Americas with over 125 years of experience.
Scale indicators5 records
Recent moves7 records
Expansion highlights5 records
Epion Therapeutics competitors and assessment
Company assessmentEmerging players
- iVeena Delivery Systems: Emerging clinical-stage company developing proprietary drug delivery approaches for corneal cross-linking and other ophthalmic indications. Direct emerging competitor in the epi-on cross-linking space pursuing similar minimally-invasive therapeutic positioning.
Broad incumbents
- Carl Zeiss Meditec: Major ophthalmic device manufacturer offering diagnostic and surgical ophthalmology equipment. Competitively adjacent through ophthalmic surgical workflows, refractive surgery, and corneal diagnostics that intersect with keratoconus management.
- Alcon: Largest pure-play ophthalmic device and pharmaceutical company globally, with surgical, vision care, and pharmaceutical franchises. Competes across ophthalmic surgery, dry eye, and refractive markets that overlap with keratoconus treatment pathways.
- Nidek Co., Ltd. Japanese ophthalmic and optometric equipment manufacturer offering diagnostic, surgical, and refractive devices. Relevant peer in corneal diagnostics, refractive surgery, and ophthalmic device manufacturing categories overlapping with EpiSmart.
- Johnson & Johnson Vision: Major ophthalmic device and vision care franchise (including former Abbott Medical Optics). Competes broadly in corneal, refractive, and cataract surgery devices; multiple Epion board members and executives previously held senior roles at J&J Vision.
- Topcon Healthcare: Ophthalmic diagnostic and imaging equipment manufacturer, including corneal topography and tomography systems used for keratoconus diagnosis. Adjacent competitive positioning in keratoconus diagnostic and management workflows.
- Bausch + Lomb (Bausch Health): Global ophthalmic medical device and pharmaceutical company with historical involvement in corneal cross-linking (acquired certain CXL assets). Broad ophthalmic portfolio competes for keratoconus patient management and surgical ophthalmology market share.
Direct peers
- Glaukos Corporation: Acquired Avedro in 2019 and now commercializes Photrexa Vibe, the only FDA-approved epi-off corneal cross-linking treatment for keratoconus in the US. Directly competes with EpiSmart in the keratoconus cross-linking market but with an epi-off rather than epi-on approach.
- Avedro (now part of Glaukos): Originally an independent company that developed and commercialized FDA-approved cross-linking technology (Photrexa/Phorcera) for keratoconus and post-LASIK ectasia. Acquired by Glaukos in 2019; remains the directly competitive epi-off cross-linking standard against which EpiSmart will compete.
Others
- OCULUS Optikgeräte GmbH: Strategic partner and investor in Epion; manufacturer of the Pentacam, the gold standard for keratoconus detection/diagnosis. Highly relevant comparison point as the diagnostic upstream gatekeeper for the keratoconus patient funnel that EpiSmart addresses.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Epion Therapeutics social profiles
Digital presenceEpion Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Epion Therapeutics leadership team
Management profileNumber of profiles
Profiles11 records
Epion Therapeutics funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Epion Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Epion Therapeutics
What does Epion Therapeutics do?
Epion Therapeutics is developing EpiSmart, a drug-device combination system for treating keratoconus (a progressive corneal ectatic disease) using transepithelial (epithelium-on) corneal cross-linking. The system integrates three proprietary components: the EpiPrep drug delivery wand and sponge, the RiboStat riboflavin-sodium iodide formulation, and a dual-head UVA light device that enables simultaneous bilateral treatment without surgical removal of the corneal epithelium.
Is Epion Therapeutics a public or private company?
Epion Therapeutics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Epion Therapeutics founded?
Epion Therapeutics was founded in 2017. It employs 11 to 50 people.
Where is Epion Therapeutics based?
Epion Therapeutics is headquartered in Burlington, United States, in the North America region.
How does Epion Therapeutics make money?
One revenue line is on record: epiSmart Cross-Linking System.
Who are Epion Therapeutics's main competitors?
iVeena Delivery Systems is listed as an emerging player. Broad incumbents are Carl Zeiss Meditec, Alcon, Nidek Co., Ltd., Johnson & Johnson Vision, Topcon Healthcare and Bausch + Lomb (Bausch Health). Direct peers are Glaukos Corporation and Avedro (now part of Glaukos). OCULUS Optikgeräte GmbH is listed as an others.
Does Epion Therapeutics have an API?
No public API is recorded for Epion Therapeutics.
What industry is Epion Therapeutics in?
Epion Therapeutics's product category is Ophthalmic medical devices. Its primary akta.pro industry code is HLAHAJAK, Cornea & External Disease Surgical Devices (Keratoplasty Tools, Cross-Linking Systems, Amniotic Membrane Delivery). Its NAICS code is 334510 and its SIC code is 3845.