Program 1 · Ophthalmology · BNSO Joint Venture
Oftac: Tacrolimus Nano-Emulsion Eye Drops
Tacrolimus is effective in uveitis but causes serious systemic side effects when taken orally. BioNanoSim's proprietary nano-emulsion, an emulsion of nano oil droplets, enables topical administration via eye drops, delivering tacrolimus to ocular tissues with low systemic exposure.
- Preservative-free tacrolimus oil-in-water nano-emulsion, mean droplet size under 200 nm
- Granted patents in multiple countries, with further applications under examination
- FDA orphan drug designation for uveitis
- 88% of patients improved by at least one anterior chamber cell (ACC) grade (p = 0.0002)
- No patient worsened: no increase in ACC grade from baseline to Day 29
- Topical administration with low systemic exposure
- Adverse events predominantly mild and local
- Phase I/IIa completed: 18 patients treated, multicentre, in Israel; final study report July 2025
Developed through BNSO
Oftac is developed by BNSO, the joint venture between BioNanoSim and Rafarm SA, which combines BioNanoSim's ocular nano-emulsion formulation with Rafarm's sterile ophthalmic manufacturing and European commercial infrastructure.
Joint Venture
BNSO · BioNanoSim + Rafarm SA
The Platform · Nano Oil-Droplet Emulsion
Oftac dissolves tacrolimus in the oil core of nano-scale oil droplets with a mean size under 200 nm, keeping the poorly water-soluble drug stable and bioavailable in a preservative-free eye drop.
Phase I/IIa Results Snapshot
88%
Improved ≥1 ACC grade
18
Patients treated
Topical
Low systemic exposure
0
Patients who got worse
Multicentre, open-label study in 18 patients treated, conducted in Israel. Primary endpoint: anterior chamber cell (ACC) grade reduction.
