Biological Innovations

Ophthalmology

autologIX for Ophthalmology

“PRP eye drops achieve 80% complete healing for neurotrophic keratitis at ~$300 — cenegermin achieves 65–74% at ~$118,000.”

The scientific rationale

The cornea is the only tissue in the body that is completely avascular. Every plasma protein, growth factor, and protease inhibitor it needs must arrive from topical delivery, the tear film, or corneal nerves — not from the bloodstream. This makes the cornea arguably the tissue most logically suited to benefit from a concentrated autologous biological platform.

PRP eye drops are now supported by three meta-analyses and over 16 RCTs. Zhang et al. (2024) conducted a network meta-analysis of 16 RCTs (898 patients) finding PRP significantly outperformed artificial tears for corneal surface damage and symptoms. For persistent epithelial defects, healing time was 2.49 weeks with PRP versus 6.82 weeks with conventional treatment (P < 0.001). For neurotrophic keratitis, Wrobel-Dudzinska et al. (2018) achieved 80% complete healing with PRP drops — comparable to cenegermin’s 65–74% in pivotal RCTs, at approximately 400 times lower cost.

autologIX adds concentrated A2M — the master protease inhibitor — which the cornea natively synthesizes (Twining et al. 1994) but which is depleted in disease (Sawaguchi et al. 1994, keratoconus). The avascular cornea cannot recruit systemic A2M to compensate. autologIX delivers it topically. Additionally, enriched IGF-1 addresses the age-related decline in tear IGF-1 that correlates with dry eye signs (Schirmer R = 0.738), while enriched HGF reverses inflammation’s anti-proliferative effect on corneal epithelium (Omoto et al. 2017).

The TFOS DEWS III report (June 2025) shifted autologous biologics from third-line to first-line treatment for neural dysfunction and ocular surface regeneration.

Clinical studies investigating autologIX outcomes for ophthalmology are in development.

Key published evidence

Zhang et al. 2024 — Network meta-analysis of 16 RCTs (898 patients). PRP outperformed artificial tears for corneal surface damage. Frontiers in Medicine.

Wrobel-Dudzinska et al. 2018 — 25 eyes with neurotrophic keratitis stages II/III. 80% complete healing with PRP drops. Journal of Ophthalmology.

Twining et al. 1994 — A2M natively synthesized by corneal epithelial, stromal, and endothelial cells. IOVS.

Sawaguchi et al. 1994 — A2M markedly reduced in keratoconus corneas (46 vs. 50 corneas). IOVS.

Omoto et al. 2017 — Topical HGF reverses anti-proliferative effect of inflammation on corneal epithelium. Molecular Therapy.

Limitations

PRP versus cenegermin has never been compared in the same trial — the 80% versus 65–74% comparison involves different study designs. No autologIX-specific ophthalmic data exist. A2M ophthalmic evidence is mechanistic, not clinical.

References
  1. Zhang W et al. Front Med. 2024;11:1500160. https://pubmed.ncbi.nlm.nih.gov/39736981/
  2. Wrobel-Dudzinska D et al. J Ophthalmol. 2018;3538764. https://pubmed.ncbi.nlm.nih.gov/30186617/
  3. Twining SS et al. Invest Ophthalmol Vis Sci. 1994;35(3):1188-94. https://pubmed.ncbi.nlm.nih.gov/7519181/
  4. Sawaguchi S et al. Invest Ophthalmol Vis Sci. 1994;35(3):992-998. https://pubmed.ncbi.nlm.nih.gov/7525507/
  5. Omoto M et al. Mol Ther. 2017;25(8):1881-1888.

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