NEW DELHI: For most people, insulin is a treatment for diabetes. Now, Mumbai-based ENTOD Pharmaceuticals has been granted an Indian patent for its insulin eye drops, marking a milestone in indigenous ophthalmic research.
The insulin eye drops are being developed to support corneal epithelial healing, especially in conditions where the cornea has difficulty repairing itself. The formulation is currently in the preclinical stage and is being investigated as a potential new treatment for unmet needs in eye care.
Speaking to TNIE, ENTOD Pharmaceuticals CEO Nikkhil K Masurkar said the company will first complete preclinical toxicology and safety studies before moving to human clinical trials in India, subject to regulatory and ethics approvals.
“The immediate next step is to complete the required preclinical programme, including toxicology and safety studies. Once these studies are satisfactorily completed, we intend to progress towards human clinical trials in India, subject to the necessary regulatory and ethics approvals.”
“We intend to approach the CDSCO (Central Drugs Standard Control Organisation) as soon as the required preclinical and toxicology work has been completed and the necessary development package is ready.”
“The precise regulatory pathway and clinical trial requirements will ultimately be determined in consultation with the regulator. Our priority is to complete the required scientific work thoroughly before progressing to the next regulatory stage,” he added.
If approved, the insulin eye drops will be a prescription-only medicine to be prescribed by an ophthalmologist after clinical evaluation. The company aims for a commercial launch by 2028, subject to all regulatory clearances.
Dr B Vijaya Lakshmi, Associate Professor of Cornea, Cataract and Refractive Surgery at Sarojini Devi Eye Hospital, Hyderabad, said insulin's biological role has made it a subject of research beyond diabetes treatment.
“Insulin is familiar to most people as an essential treatment for diabetes, but its biological role has made it a subject of scientific interest far beyond blood sugar management.”
“Exploring its potential through an eye drop is an innovative and fascinating direction for ophthalmic research. The ability to investigate an established biological molecule through a completely different route of delivery could potentially open new avenues for scientific understanding.”
“While its safety and therapeutic value will need to be established through rigorous research and clinical studies, it is innovations such as these that encourage us to look beyond conventional approaches in the search for better solutions in eye care,” she said.
One of the key potential applications is neurotrophic keratitis, a degenerative corneal disease linked to reduced corneal sensation and poor healing. The formulation is also being studied for diabetic keratopathy and persistent corneal epithelial defects, where delayed corneal wound healing is a major clinical problem.
“Insulin is of scientific interest in this area because insulin-related signalling is involved in epithelial cell migration, proliferation and wound healing. ENTOD’s development programme will investigate whether its proprietary topical insulin formulation can safely promote corneal repair,” Masurkar said.
He clarified that the insulin eye drops are being developed only for ophthalmic use and are not intended to replace injectable insulin or other diabetes treatments.
“The eventual approved indication, including its potential role in neurotrophic keratitis, diabetic keratopathy and persistent corneal epithelial defects, will depend on the results of clinical trials and regulatory approval,” he said.
According to the ICMR-INDIAB study, around 101 million people in India are living with diabetes. Published international studies estimate that diabetic keratopathy affects about 46–64% of people with diabetes.
ENTOD Pharmaceuticals was granted Indian Patent No. 595378 for its invention titled “A topical Insulin Eye drop formulation and method thereof.” The patent was filed on May 29, 2024, and is valid for 20 years from the filing date, subject to the Patents Act.
Masurkar said the patent reflects India's growing capability in pharmaceutical innovation.
“Our R&D team has worked tirelessly to explore a therapeutic approach that could potentially open new avenues in ophthalmic treatment. We remain committed to pushing the boundaries of research from India—for India, for the Global South, and ultimately for the world.”
“We believe this represents an important innovation in the development of a purpose-designed pharmaceutical insulin eye-drop formulation. While topical insulin has previously been investigated in academic and clinical research, ENTOD’s patent specifically covers its proprietary formulation and method,” he added.
