The company aims to remedy hitherto incurable dry Age-Related Macular Degeneration (AMD) - the leading cause of blindness, affecting about 170 million people worldwide.
Bengaluru, 20th February 2020 : In its endeavour to create first-in-class advanced therapies in India with global benchmarks, Eyestem Research is delighted to announce successful completion of a pre-IND (Investigational New Drug) meeting with the FDA regarding regulatory roadmaps for its flagship product.
Eyecyte-RPE, a patent-pending suspension of Retinal Pigment Epithelium cells, is designed to arrest and reverse symptoms of dry Age-Related Macular Degeneration (AMD) – an incurable cause of blindness that affects about 170 million people globally. Eyestem is among the very few companies worldwide which are racing to find a cure for this debilitating condition. Once the IND application is filed this year, the start-up plans to commence the clinical trials by next year.
Commenting on the positive development, Dr. Jogin Desai, Founder and CEO, Eyestem said, “We are on a mission to democratize access to cell therapy and make it available to a large section of humanity. The pre-IND meeting is aimed at creating a validated regulatory roadmap and we are delighted to obtain encouraging feedback from the FDA on our intended development path. As the only Indian company in this segment, we are determined to make the most of our exceptional pre-clinical animal results in order to find a cure for Dry AMD. We are fortunate to have a superb partner in Ora clinical, the world’s leading ophthalmology research organization for creation of the regulatory roadmap. We now look forward to starting clinical trials on the product by next year”
Last year, the company had raised an undisclosed amount in funding from global investors in Switzerland and South Africa. It is also ably supported through grants by BIRAC, the investment arm of the Department of Biotechnology, India and by Centre for Cellular and Molecular Platforms. The company will use this momentum to raise the next round of funds to get to the end of phase one trials.
Jeanne Hecht, CEO, Ora Clinical said, “As one of the top ophthalmic contract research organisations (CROs) in the world, we recognise the need to nurture ideas that can change the world. Eyestem’s pioneering work can halt the progression of dry AMD by using a unique composition of retinal cells to restore the health of the retina and we are incredibly excited to be partners in their journey”
Eyestem’s vision is to create a global and scalable cell therapy platform that produces consistent and quality products to treat incurable diseases. The company, founded by a top-class management team consisting of clinical trial, cell therapy and ophthalmology experts, boasts of a world-class advisory board and collaborations with pioneers and global industry leaders.
BOX: What’s dry AMD?
• The eye’s macula, located near the center of the retina, is responsible for sharp, clear, straight-ahead vision. Dry Age-related macular degeneration (AMD) occurs when macula degenerates with increasing age. It starts with loss of central vision and ultimately leads to blindness.
• Wet AMD, a variant of AMD, is treatable and the global market of drugs for wet AMD is expected to reach USD 8.9 billion by 2022.
• The incidence of dry AMD incidence is nine times that of wet AMD. Yet, there is no cure for dry AMD.
FOR ANY FURTHER MEDIA INFORMATION, PLEASE CONTACT
Trisha Sirur | Lokesh Kumar | Sudhakar Rao
MbL: 90359 00388 | 91641 64788 | 99161 38037
Lateral Thinkers, PR, Bangalore
Bengaluru-based start-up to take its flagship product, Eyecyte-RPE, to human clinical trials in 18 months. If successful, it will be among the first few companies globally to find a treatment for Dry AMD, the largest cause of incurable blindness that affects nearly 170 million people worldwide
Bengaluru, July 2019: Eyestem, India’s leading cell therapy company, has raised an undisclosed amount in funding from global investors in Switzerland and South Africa. The investment will boost the Bengaluru-based start-up’s efforts to find a treatment for Dry Age-related Macular Degeneration (Dry AMD), the leading cause of incurable blindness affecting almost 170 million people – mostly above 50 years of age – across the globe.
Founded by a top-class management team consisting of clinical trial, cell therapy and ophthalmology experts, Eyestem has created a platform for allogeneic, scalable cell therapy. Eyecyte-RPE, the company’s flagship product, holds the promise of finding a treatment for Dry AMD. The recent funding will help the company to complete all the pre-clinical work to file for an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) and be ready for phase one clinical trials by end of next year.
The current round was led by Zurich based Jacesa investments, South Africa based Church Street Trustees and Gillian Corken. India based Impres Health also participated in the round.
Commenting on the positive developments, Dr. Jogin Desai, Founder and CEO, Eyestem, said, “Cell-based therapy is the transplantation of human cells grown in a laboratory to replace or repair damaged cells in the body. We have received excellent pre-clinical animal results for Eyecyte-RPE, our product to treat macular degeneration, from our partners at the Oregon Health and Science University, USA. We now intend to take the product forward and aim to be in human clinical trials in 18 months. It is encouraging to know that experienced and senior healthcare professionals from around the world have faith in our vision and have invested in us. We will be deploying these funds to manufacture the product, do confirmatory efficacy and toxicology and file an IND application.”
Global investors are seeing a huge potential in the hitherto untapped market, which players like Eyestem are well-positioned to disrupt. “Eyestem has the ambition of creating a cell therapy platform which is scalable. It has the potential to disrupt the global cell therapy ecosystem, which is currently facing scale and pricing challenges,” agreed Gert Hoogland, (Jacesa Investments).
According to the other investors, Prof.Oppel Greeff (Church Street Trustees) and Gillian Corken, “Eyestem is among a handful of companies globally who are leading the charge to treat macular degeneration and retinitis pigmentosa, both incurable diseases of the eye.”
“What made us invest in Eyestem is its global ambition, driven by its unique management team, which has a deep understanding of cellular biology, regulatory roadmaps and retinal degeneration,” they remarked.
As global investors and seasoned healthcare professionals exhibit growing interest in Indian start-ups, the Indian ecosystem is also taking note of home-grown businesses that have the potential to revolutionise the industry.
Ashok Vohra, Managing Director, Impres Health, is confident that investing in Eyestem will pave the way for a healthier future. “Eyestem has significant potential to be a global player in the new frontiers of cell therapy and we are proud to be associated with them,” he maintained.
Eyestem, which boasts of a world-class advisory board and collaborations with pioneers and global industry leaders, aims to create multiple cell-based products over the next few years to help treat intractable and incurable diseases through its scalable cell therapy platform.For any further information, please contact
Dhanusha Sasidharan | Lokesh Kumardhanusha@lateralthinkers.co.in | firstname.lastname@example.org
MbL: Lateral Thinkers, PR, Bangalore
We are delighted to share positive animal efficacy results from Dr. Trevor McGill ( About Dr. Trevor McGill) at the Oregon Health and Science University for EyecyteRPE: our lead product for treatment of Dry AMD (macular degeneration)
As per Dr.McGill "EyecyteRPE provided significant beneficial effects on the degenerating retina in RCS ratswithout any significant safety concerns suggesting this cell type may have significant therapeutic value in human retinal degenerative disease".
Dr. Jogin Desai, Founder and CEO, Eyestem Research said " The POC results have shown significant preservation of photoreceptors and functional rescue of vision and the results are at par or better than most published data globally. We will be using this momentum to now aggressively move forward into GLP toxicology, larger efficacy and GMP production for our product for Dry AMD."
Eyestem was awarded a multi-crore grant under the Biotechnology Industry Partnership Programme.(BIPP) by the Department of Biotechnology, India. The grant will advance EyecyteRPE through GMP manufacturing and GLP toxicology studies. It is one of the largest ever grants accorded to a start-up in the medical biotech space.
Eyestem is among the top 30 startups selected by #LevelNXT, India’s most comprehensive scaleup programme to recognize and nurture high-growth scaleups, hosted by PwC and FICCI. The program is meant to unearth the brightest entrepreneurs and offer them a collaborative ecosystem and easier access to growth networks.
From an Economic Times report: Jogin Desai brings the global regulatory experience that can help scientists look ahead. His strategy is to be based in Bengaluru but leverage specialised skills from around the world. So, Eyestem has a set of advisors and collaborators in the country and in some of the best labs in the world. The company has started growing retinal cells in its lab through a unified protocol that can be used by technicians and hopes to begin clinical trials by 2020.