Entod gets CDSCO approval on eye drop developed to slow the progression of myopia in children

Entod Pharmaceuticals expects to roll out an eye drop developed to slow the progression of myopia in children aged 6 to 12 years, by early June.

The company received the Central Drugs Standard Control Organisation’s (CDSCO) regulatory approval for a new eye drop, a first of sorts in its strength, said Nikkhil K Masurkar, Chief Executive of Entod Pharmaceuticals. The product had completed advanced Phase III clincial trials in 198 children across 11 sites, Masurkar told businesline, adding that it had potential for the domestic and export market, especially in South East Asian countries.

This treatment will be available on prescription from a registered medical practitioner for children diagnosed with myopia, following an evaluation by an eye doctor, the company said. The company has been researching the product for about three years, and has a similar product but with a lower strength, he said, adding that both products would remain in the market. Details on the composition of the product were kept confidential.

Product’s significance

Explaining the product’s significance, he said, “With myopia rates in India rising from 4 percent in 1999 to nearly 25 percent today, and projections suggesting that by 2050 one in two children could be affected, the need for such a therapy has never been more urgent.”

Entod had launched 22 projects last year, Masurkar said, adding that research spends would increase from 2 percent of revenues (undisclosed) to about 3.5 percent. The 47 year old company has a pipeline of products across opthalmology, ENT and dermatology segments.

Late last year, the company had found itself in a spot over one of its products that claimed to reduce dependency on reading glasses for individuals affected by presbyopia. Top company officials had however stood behind the product saying it was an approved, clinically tested, purely prescription-driven drug.

Published on April 28, 2025