Eyestem to start first trial in India to treat age-related blindness

Soon, people with dry age-related macular degeneration (AMD) — the largest cause of incurable blindness in people above 60 years — may have a second chance some ray of hope if the investigational cell therapy product Eyecyte-RPE of Bengaluru based start-up Eyestem clears clinical trials.

Currently, there is no cure for dry AMD.

Eyestem, which has recently raised Rs 51 crore in a series A round led by three pharma firms — Alkem, Natco and Biological E — is now looking to start a phase 2a/2b clinical trial for its experimental ophthalmology product by the first half of next year.

Apart from dry AMD, the company is also developing treatments for retinitis pigmentosa and idiopathic pulmonary fibrosis. It has developed the product for retinitis pigmentosa, which affects children from the age of five who start to lose vision (because of loss of photo-receptors), and they become completely blind by 30.

“We have developed the product for retinitis pigmentosa in the lab, and we plan to go for animal trials next year,” Jogin Desai, founder, Eyestem, said.

Desai told Business Standard that they are in talks with the Drugs Controller General of India (DCGI) for the trials. They are also in talks with some large pharmaceutical companies overseas to take this product outside, and commercialise it globally. As for India, Desai said that human trials can start as soon as the first half of next year.

“We are an India-focused company, and we want to ensure that our product is first available in India, and at an affordable rate,” Desai said. Eyecyte-RPE is an allogenic product (outside cells), and does not need to be customised for each patient. This is a scalable product that can be mass produced, Desai said, adding that otherwise costs can be out of reach for most patients.

It is a sub-retinal injection (300 microliters) which can be given to the patient in a procedure to be done in an operation theatre. “We have done these experiments in Singapore and are now finalising the way this injection would be administered,” Desai says.

There cannot be a phase 1 clinical trial for this product as one cannot administer a subretinal injection to a healthy volunteer. “We have done animal trials, and we have data on rats, rabbits and primates,” Desai says. The phase 2a/2b trials will be conducted on 45-50 patients.

The first nine patients that they will inject would be legally blind, as they have to prove safety first. “We will observe these patients for about 4-5 months. Once we inject the first set of patients with intermediate macular degeneration, we will know the results in about six months,” Desai said.

It will be very rare for a legally blind patient to have reversal in vision loss, but for intermediate patients this therapy would halt the decline in condition due to progression of the disease. “In 25 per cent of patients, we have seen they can see 15 letters or more, and on an average they can see 8 letters,” Desai says.

He adds that it is estimated that nearly 1.5 per cent of India’s population have some stage of dry AMD. Above the age of 60, almost one in three people are affected by this degenerative disorder. In fact, it is considered the largest cause of blindness for people above 50 years, and affects roughly 170 million people worldwide. It is estimated that about 15-40 million people in India suffer from AMD.

There may not be a need for a phase 3 clinical trial as this is a huge unmet need in India, Desai said, adding that it will depend on the decision of the drug regulator.

At present the manufacturing is done at an eye hospital, and post the clinical trials, the manufacturing may be done at a contract development and manufacturing company Kemwell. Anurag and Karan Bagaria, promoters of Kemwell Biopharma are investors in Eyestem.

Desai did not wish to comment on the potential pricing of the product, but said it will be a fraction of the global cost. The allogenic products on dry AMD that may come soon will be in the range of $100,000 or more.

The eyes have it

• Eyestem expects to start phase 2a/2b clinical trials for Eyecyte-RPE by first half of 2023
• Macular degeneration is a leading cause of central vision loss in people aged 60 years or above
• The condition affects roughly 170 million people worldwide; and 15-40 million people in India
• Currently there is no cure for dry AMD