Epion Therapeutics
Clinical-stage ophthalmic company developing a minimally invasive epithelium‑preserving corneal cross-linking system to treat keratoconus and ectatic corneal disease. Activities include large-scale clinical trials, drug‑device combination development (riboflavin-based formulation plus UV-A illumination), regulatory engagement with FDA, intellectual property protection, and commercial partnerships for device engineering and manufacturing.
Industries
Nr. of Employees
small (1-50)
Patents
Ophthalmic treatment solution delivery devices and delivery augmentation methods
US-11931291-B2
View Details
Ophthalmic treatment solution delivery devices and delivery augmentation methods
US-11931291-B2
View DetailsProducts
Epithelium‑on corneal cross‑linking system
Investigational minimally invasive drug‑device system that preserves the corneal epithelium while delivering a riboflavin‑based formulation and UV‑A illumination to strengthen corneal tissue; designed for simultaneous bilateral treatment and rapid recovery.
EpiSmart system
A patented system for Epi-on corneal cross-linking that includes devices for non-disruptive cleansing of the corneal surface, homogeneous drug delivery, and a bilateral, simultaneous cycling UV-A light device. It allows minimally-invasive treatment of keratoconus and other corneal ectasias without removal of the corneal epithelium.
EpiSmart Epithelium-On Corneal Cross-Linking System
An alternative corneal cross-linking treatment by Epion Therapeutics intended to preserve the cornea’s surface, reduce discomfort, speed up recovery time, and minimize the risk of scar formation and infection. Currently being evaluated in Phase 3 clinical trials at over 20 locations in the United States.
RiboStat™
A riboflavin 5’-phosphate 0.5% and sodium iodide 0.015% ophthalmic drug formulation used with the EpiSmart system for transepithelial corneal cross-linking.
EpiPrep™
CLXO’s proprietary drug delivery system for epi-on cross-linking, patented for ophthalmic treatment solution delivery devices and delivery augmentation methods.
Epithelium‑on corneal cross‑linking system
Investigational minimally invasive drug‑device system that preserves the corneal epithelium while delivering a riboflavin‑based formulation and UV‑A illumination to strengthen corneal tissue; designed for simultaneous bilateral treatment and rapid recovery.
EpiSmart system
A patented system for Epi-on corneal cross-linking that includes devices for non-disruptive cleansing of the corneal surface, homogeneous drug delivery, and a bilateral, simultaneous cycling UV-A light device. It allows minimally-invasive treatment of keratoconus and other corneal ectasias without removal of the corneal epithelium.
EpiSmart Epithelium-On Corneal Cross-Linking System
An alternative corneal cross-linking treatment by Epion Therapeutics intended to preserve the cornea’s surface, reduce discomfort, speed up recovery time, and minimize the risk of scar formation and infection. Currently being evaluated in Phase 3 clinical trials at over 20 locations in the United States.
RiboStat™
A riboflavin 5’-phosphate 0.5% and sodium iodide 0.015% ophthalmic drug formulation used with the EpiSmart system for transepithelial corneal cross-linking.
EpiPrep™
CLXO’s proprietary drug delivery system for epi-on cross-linking, patented for ophthalmic treatment solution delivery devices and delivery augmentation methods.
Services
Design and execution of multicenter clinical trials and preparation for regulatory submissions for investigational corneal therapies.
Design and execution of multicenter clinical trials and preparation for regulatory submissions for investigational corneal therapies.
Expertise Areas
- Clinical trial management
- Drug‑device combination development
- Ophthalmic device engineering
- Corneal therapeutics and cross‑linking
Key Technologies
- Epithelium‑preserving (epi‑on) corneal cross‑linking
- Riboflavin‑based photochemical cross‑linking formulations with iodide
- UV‑A light therapy devices with light cycling protocols
- Bilateral simultaneous treatment device architectures
News & Updates
Final patient completed last study visit across two pivotal Phase 3 trials evaluating an investigational epithelium‑preserving corneal cross‑linking procedure for keratoconus; studies enrolled ~800 patients across 26 U.S. sites.
FDA granted Fast Track designation for the investigational drug‑device combination intended to treat keratoconus, facilitating interactions with FDA and potential expedited review pathways.
Announcement of full enrollment in two Apricity Phase 3 trials evaluating the epithelium‑preserving cross‑linking approach in keratoconus patients.
Grant of a U.S. patent for a core light therapy device component of the epithelium‑preserving cross‑linking system; portfolio includes multiple U.S. and European patents.
Announcement of an $18.5M financing round and strategic manufacturing/engineering partnership to advance device development and manufacturing.
Largest-to-date Phase 2 study of corneal cross‑linking for keratoconus (thousands of subjects) demonstrating improvements in visual acuity and favorable safety compared to epi‑off approaches.
Final patient completed last study visit across two pivotal Phase 3 trials evaluating an investigational epithelium‑preserving corneal cross‑linking procedure for keratoconus; studies enrolled ~800 patients across 26 U.S. sites.
FDA granted Fast Track designation for the investigational drug‑device combination intended to treat keratoconus, facilitating interactions with FDA and potential expedited review pathways.
Announcement of full enrollment in two Apricity Phase 3 trials evaluating the epithelium‑preserving cross‑linking approach in keratoconus patients.
Grant of a U.S. patent for a core light therapy device component of the epithelium‑preserving cross‑linking system; portfolio includes multiple U.S. and European patents.
Announcement of an $18.5M financing round and strategic manufacturing/engineering partnership to advance device development and manufacturing.
Largest-to-date Phase 2 study of corneal cross‑linking for keratoconus (thousands of subjects) demonstrating improvements in visual acuity and favorable safety compared to epi‑off approaches.