Draft:EndoArt
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| Manufacturer | EyeYon Medical Ltd. |
|---|---|
| Inventor | Ofer Daphna |
| CEO | Nahum Ferera (co-founder) |
| Website | eye-yon |
EndoArt is a synthetic corneal endothelial replacement device developed by EyeYon Medical, used to treat chronic corneal edema caused by corneal endothelial dysfunction.[1] It is a thin, dome-shaped disc made of an acellular hydrophilic acrylic polymer, a material also used in some intraocular lens implants. Because it contains no biological donor material, it is not subject to immunological graft rejection or donor-tissue cellular damage, and its barrier function does not deteriorate under inflammatory conditions. The device is placed against the posterior corneal stroma, where it acts as a passive barrier blocking the movement of aqueous humor into the cornea, and is secured initially with an intracameral gas bubble and later by collagen interaction.[1]
The device is intended for adults with chronic corneal edema caused by a damaged corneal endothelium. The most frequently reported complication is implant detachment, usually within the first three months after surgery, treated with rebubbling.[2] In published case series, most patients experienced improved vision after implantation, with some regaining visual acuity as good as 20/32.[3][4][5] According to EyeYon Medical, as of mid-2026 EndoArt had been implanted in more than 1,200 patients worldwide.[6]
Indications
[edit]According to the manufacturer's instructions for use, EndoArt is intended for use as an endothelial prosthesis in patients aged 40 years or older with chronic corneal edema due to endothelial dysfunction.[7]
Published clinical use to date has been concentrated in patients who are not suitable candidates for conventional donor posterior lamellar corneal transplantation (endothelial keratoplasty), such as Descemet membrane endothelial keratoplasty (DMEK) and Descemet stripping automated endothelial keratoplasty (DSAEK), due to repeated graft failure arising from complex ocular conditions (for example, immunological rejection or prior glaucoma drainage device surgery). According to the manufacturer's patient-profile materials, additional candidate groups include patients with:[6]
- Limited or no access to donor corneal tissue
- Glaucoma drainage devices
- Eyes filled with silicone oil
- Complex ocular comorbidities
- Severe corneal edema outside standard indications
- Cultural or religious objections to receiving human donor tissue
- Patient preference
Clinical evidence
[edit]EyeYon Medical sponsored two multicenter clinical studies of EndoArt, both registered on ClinicalTrials.gov. The first was a 22-patient feasibility study conducted between 2017 and 2023 in Germany, Israel, the Netherlands, and Spain.[8] The second enrolled 52 patients between 2021 and 2023 at centers in France, Germany, the Netherlands, Georgia, India, and Israel.[9] Data from this clinical program supported EndoArt's CE marking and commercial availability in the European Union.
Independent of these company-sponsored trials, a pooled analysis of three peer-reviewed publications examined 22 EndoArt-treated eyes with follow-up ranging from 2 to 6 years.[3][4][5] Corneal thickness decreased consistently across all three studies, from a weighted average of approximately 846 to 593 µm. Visual acuity improved in 16 of 22 eyes (73%), with the best reported vision reaching approximately 20/32. Two implants required removal, a long-term retention rate of approximately 91%; the study authors noted that this compared favorably with reported retention rates for repeat donor transplantation in similarly high-risk eyes.[3][4][5]
Regulatory status
[edit]EndoArt has received CE marking in the European Union and is commercially available there. It has also been granted FDA Breakthrough Device Designation, and in December 2025 the FDA granted Investigational Device Exemption (IDE) approval to begin a U.S. clinical study; a pivotal trial to support a future U.S. marketing application was registered in 2026.[6][10] In China, the manufacturer reports Green Channel priority-review status from the National Medical Products Administration (NMPA).[7]
References
[edit]- 1 2 Daphna, O; et al. (2025). "A novel artificial endothelial replacement membrane for the treatment of chronic corneal edema". Cornea. 44 (10): 1240–1247.
- ↑ Bachmann, BO; et al. (2026). "EndoArt: indications, mechanism of action, outcomes, and complications". Klinische Monatsblätter für Augenheilkunde. 243: 660–668.
- 1 2 3 Son, HS; et al. (2025). "Long-term observations of the first human implantation of an artificial endothelial layer for endothelial dysfunction: a pilot study". Cornea.
- 1 2 3 Lapid-Gortzak, R; van der Meulen, I (2025). "4.5-year follow-up with a novel corneal endothelial prosthesis". Klinische Monatsblätter für Augenheilkunde. 242 (4): 318–323.
- 1 2 3 Fontana, L; et al. (2025). "Long-term clinical outcomes and anterior segment optical coherence tomography findings after artificial endothelial replacement membrane implantation". Cornea.
- 1 2 3 Harp, MD (2025-12-08). "FDA grants IDE approval to EyeYon Medical for its US clinical study of EndoArt". Ophthalmology Times. Retrieved 2026-09-08.
- 1 2 "Instructions for Use: EndoArt Corneal Artificial Endothelial Layer" (PDF). EyeYon Medical. LBL0074 Rev.4. Retrieved 2026-09-08.
- ↑ "Prospective, Feasibility Study to Evaluate the Safety of the EndoArt for Treatment of Subjects Suffering From Corneal Edema". ClinicalTrials.gov. NCT03069521. Retrieved 2026-09-08.
- ↑ "An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt Implantation in Subjects With Chronic Corneal Edema". ClinicalTrials.gov. NCT05139771. Retrieved 2026-09-08.
- ↑ "A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed". ClinicalTrials.gov. NCT07344168. Retrieved 2026-09-08.