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Peer-reviewedCC BY-NC-ND 4.0BMC Ophthalmology

Ocular safety of subconjunctival injection of tacrolimus in rabbits

6 affiliations
  1. 1Ophthalmology Department, Alex I-Care Center, Alexandria, Egypt
  2. 2Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Egypt
  3. 3Ophthalmology Department, Research Institute of Ophthalmology, Giza, Egypt
  4. 4Pathology Department, Research Institute of Ophthalmology, Giza, Egypt
  5. 5Pathology Department, Ismailia Teaching Oncology Hospital, Ismailia, Egypt
  6. 6Ophthalmology Department, Doctor Samir Eye Clinic, Street 288, Alexandria, Smouha 5432013 Egypt

Abstract

Aim The main aim of this study was to evaluate the safety of subconjunctival injection of tacrolimus in rabbit eyes. Methods Ten white New Zealand rabbits were included. A concentration of tacrolimus 0.03% was prepared for subconjunctival injection. Tacrolimus 0.03% was compounded by adding water for injection solution to 1,000 µg tacrolimus capsule (Prograf; Astellas Pharma Inc., Tokyo, Japan) to achieve 0.03% concentration. Prograf capsule inactive ingredients (excipients) inside the core included hypromellose, croscarmellose sodium, lactose monohydrate, and magnesium stearate. Tacrolimus 0.03% was injected subconjunctivally in one eye of each rabbit and water for injection solution was injected subconjunctivally into the contralateral eye. All rabbits underwent ocular examination in the 1st, 3rd, 10th and 30th day after injection. The following parameters were evaluated: tearing, hyperemia, conjunctival chemosis, and scleral necrosis/discoloration. The rabbits were sacrificed 30 days after injections and histopathological examination was performed on enucleated eyes. Results No tearing or scleral necrosis/discoloration was observed in either group. In the tacrolimus-injected eyes, conjunctival hyperemia and chemosis were minimal compared to the water-injected control eyes, where severe hyperemia was noted initially but improved over time. Histopathological examination revealed less lymphocytic infiltration and better-preserved scleral and corneal structures in the tacrolimus group. Conclusion Subconjunctival tacrolimus demonstrated a promising safety profile. No serious adverse events were noted clinically or pathologically.

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BibTeX
@article{hassanin2026ocular,
  title = {{Ocular safety of subconjunctival injection of tacrolimus in rabbits}},
  author = {Zakaria Hassanin and Ahmed Shama and Nancy Zakaria and Islam A. Mohalhal and Mohammed Awad and Iman Zaki and Ahmed A. Elmetwally and Samir Shoughy},
  journal = {BMC Ophthalmology},
  year = {2026},
  month = nov,
  doi = {10.1186/s12886-026-05487-0},
  url = {https://doi.org/10.1186/s12886-026-05487-0},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Ocular safety of subconjunctival injection of tacrolimus in rabbits
AU  - Zakaria Hassanin
AU  - Ahmed Shama
AU  - Nancy Zakaria
AU  - Islam A. Mohalhal
AU  - Mohammed Awad
AU  - Iman Zaki
AU  - Ahmed A. Elmetwally
AU  - Samir Shoughy
PY  - 2026
DA  - 2026/11/04
JO  - BMC Ophthalmology
DO  - 10.1186/s12886-026-05487-0
UR  - https://doi.org/10.1186/s12886-026-05487-0
AB  - Aim The main aim of this study was to evaluate the safety of subconjunctival injection of tacrolimus in rabbit eyes. Methods Ten white New Zealand rabbits were included. A concentration of tacrolimus 0.03% was prepared for subconjunctival injection. Tacrolimus 0.03% was compounded by adding water for injection solution to 1,000 µg tacrolimus capsule (Prograf; Astellas Pharma Inc., Tokyo, Japan) to achieve 0.03% concentration. Prograf capsule inactive ingredients (excipients) inside the core included hypromellose, croscarmellose sodium, lactose monohydrate, and magnesium stearate. Tacrolimus 0.03% was injected subconjunctivally in one eye of each rabbit and water for injection solution was injected subconjunctivally into the contralateral eye. All rabbits underwent ocular examination in the 1st, 3rd, 10th and 30th day after injection. The following parameters were evaluated: tearing, hyperemia, conjunctival chemosis, and scleral necrosis/discoloration. The rabbits were sacrificed 30 days after injections and histopathological examination was performed on enucleated eyes. Results No tearing or scleral necrosis/discoloration was observed in either group. In the tacrolimus-injected eyes, conjunctival hyperemia and chemosis were minimal compared to the water-injected control eyes, where severe hyperemia was noted initially but improved over time. Histopathological examination revealed less lymphocytic infiltration and better-preserved scleral and corneal structures in the tacrolimus group. Conclusion Subconjunctival tacrolimus demonstrated a promising safety profile. No serious adverse events were noted clinically or pathologically.
SN  - 1471-2415
ER  -