Researchers of the SI "The Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine" continue to conduct fundamental research aimed at improving scientific approaches to the development of safe and effective ophthalmic medicines.
One of the promising research areas of the Institute's Laboratory of Pharmacology is the investigation of the biological and toxicological properties of plant-derived components used in the manufacture of ophthalmic medicinal products.
Under the supervision of Halyna Stepanivna Fesiunova, Candidate of Biological Sciences, Head of the Pharmacology Laboratory at the Filatov Institute, a study was conducted to determine the safe limit for the content of aloin—a specific impurity present in aloe-based preparations— by assessing its acute ophthalmotoxicity.
Aloe is widely used in medicine due to its anti-inflammatory, regenerative and reparative properties. Of particular value to ophthalmology are the plant’s polysaccharides, which promote the regeneration of eye tissues. At the same time, aloe contains aloin — a phenolic compound that current toxicological studies regard as a potential risk factor. This is precisely why international quality standards regulate the permissible content of this substance in medicinal products.

Since the current regulatory limits were established without taking into account the specific characteristics of the ophthalmic use of aloe-based preparations, researchers at the Filatov Institute set out to experimentally confirm their safety specifically for ophthalmic dosage forms.

During the study, model eye drop solutions with aloin concentrations of 10 ppm and 20 ppm were prepared. The preclinical studies were performed in accordance with current methodological guidelines using an experimental chinchilla rabbit model. Local ocular toxicity was assessed following repeated instillations of the formulations by means of clinical and biomicroscopic examinations using the internationally recognised Draize scale.
Main Findings of the study

The study results confirmed the absence of clinically significant local toxic effects at the investigated aloin concentrations. The total score for changes in eye tissue did not exceed two points, which is significantly below the threshold values for irritant effects.Based on the studies conducted, it has been scientifically established that the safe limit for aloin content in ophthalmic preparations should not exceed 10 ppm.

Scientific Significance of the Study
The results obtained expand fundamental knowledge regarding the biological safety of specific plant-derived impurities and are of great importance for the development of pharmacology, toxicology and ophthalmology.
The study provides a scientific basis for the further improvement of quality requirements for ophthalmic medicinal products, promotes the harmonisation of national regulatory documents with international standards, and may serve as a foundation for the development of new aloe-based medicinal products.
The research team included Halyna Fesiunova, Serhii Kisil, Hanna Abramova, and Yelyzaveta Mamaieva.
The study findings were presented as an oral presentation at the 2nd All-Ukrainian Scientific and Practical Conference with International Participation "Interdisciplinary Approaches to Drug Development" (Odesa, 14–15 April 2026).

Research of this calibre confirms the high scientific potential of the Filatov Institute as one of Ukraine's leading ophthalmic research centres. The combination of fundamental research, a modern experimental infrastructure, and many years of clinical experience enables the development of innovative, scientifically substantiated solutions that meet current international requirements for the quality and safety of medicinal products.
Publication
Fesiunova H. S., Kisil S. M., Abramova H. B., Mamaieva Ye. I. Determination of the Acceptability of the Selected Limit for the Aloe-Specific Impurity Aloin by Acute Ocular Toxicity Testing.// Interdisciplinary Approaches to Drug Development: Proceedings of the 2nd All-Ukrainian Scientific and Practical Conference with International Participation (Odesa, 14–15 April 2026). Odesa: Odesa I. I. Mechnikov National University, 2026.
Electronic Repository of the Filatov Institute