Eyestem to submit data for approval of phase 2a first-in-human study to DCGI for Eyesight RPE for dry AMD
Eyestem will be submitting data for approval of phase 2a first-in-human study for its product named as Eyesight RPE to the Drugs Controller General of India (DCGI) for dry age-related macular degeneration (AMD).
The approval will be a significant milestone because in dry AMD, the retinal pigment epithelium, the layer of the retina on which the photoreceptors sit, is destroyed. About 3 crores people in this country suffer from it and there is no cure anywhere in the world for this. There is another variant known as wet AMD for which injections can be administered, but there is no such injection available for dry AMD as of today.
It is the largest cause of blindness for people above 50. About 170 million people in the world suffer from it, out of which 30 million are in India.
Eyestem is one of a handful of startups globally developing cellular therapies to address blindness and loss of lung function. It has a pole position in the race to solutions for AMD, retinitis pigmentosa and idiopathic pulmonary fibrosis. Eyestem is just 3 years from its first commercial revenue.
According to Dr. Jogin Desai, CEO and founder, Eyestem, “Since this is a disease that has no cure, we are hoping that we should be able to have a conversation with the DCGI on doing a phase 2b and then onwards to commercialization. The idea would be for us to subretinally inject inside the eye and deposit the cells and make sure that the cells then, hopefully, integrate and secrete some factors which can help revive the diseased state of the eye.”
“EyeCyte-RPE replaces lost retinal pigment epithelium cells. It is designed to restore sight for patients in the early stages of macular degeneration and arrest losses for those in the later stages. The product is allogenic and administered by subretinal injection. It’s first in-human application is in the pipeline. Eyestem is one of six players globally developing this solution,” Dr. Desai added.
Talking about the clinical trial, Dr Desai informed that it is a multicentric trial, but it will be in India. We’ll start with India. LV Prasad Eye Institute, Hyderabad is our primary site. We are also having conversation with All India Institute of Medical Sciences (AIIMS) in New Delhi and another hospital in Ahmedabad. These are the three most likely primary sites for us. They will start with about 40 to 45 patients. We will first start with the legally blind patients because we have to prove safety. Without safety, there can’t be efficacy. Once there is safety, then we will create a dose expansion strategy and move toward patients who have intermediate-stage dry AMD.
Dr Desai further explained that the Indian Council of Medical Research (ICMR) has published cell and gene therapy guidelines. The Central Drugs Standard Control Organization (CDSCO) has its own standards. In any new therapy, there is always an education period that we have to do. For example, the eye’s separation space is so small that you can only inject 100 microliters into the entire thing. How do you then create your toxicology reports? How do you do bio distribution? That is a challenge that is not present in our traditional medicine. So, we are working with the DCGI to discuss with them how we have solved these problems.
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AuroBlog | Clinical Research Blog | Aurous HealthCare CRO, India 