Dry age-related macular degeneration (Dry AMD) is the largest cause of incurable blindness in the world for patients over 50 years. 170 million people suffer from this disease around the world, 25 million of which are in India. These numbers will unfortunately increase in the coming decades as our population ages. The more severe version of Dry AMD is Geographic Atrophy and no therapy is available to arrest or reverse loss of vision.

Eyestem Research today announced the submission of an Investigational New Drug Application to Central Drugs Standards Control Organization, India (CDSCO) to begin first in human trials of Eyecyte-RPE™ for subjects with medium and late stage Geographic Atrophy, secondary to Dry Age related Macular Degeneration.

Dr. Rajani Battu, Chief Medical Officer, Eyestem Research said “We are excited to start human trials for Eyecyte-RPE™. Dry AMD is a huge disease burden, and this therapy has the potential to make a meaningful difference in our patient lives”.

Dr. Jogin Desai, Chief Executive Officer, Eyestem Research said “Most cell and gene therapy products under development in the West are estimated to cost over US $ 200,000. Our vision is to democratize access to such treatments at a fraction of these costs and begin disruption of the current status quo with our Eyecyte-RPE™ product"

Eyestem Research is a deep science company incubated at the Centre for Cellular and Molecular Platforms, Bangalore and supported by DBT-BIRAC as well as prestigious Indian and global healthcare investors. The IND submission for Eyecyte-RPE™ is supported by robust GLP toxicology data from Dabur Research Foundation in India and excellent efficacy/safety data in animal models in Oregon Health and Science University. Validation of the injection technique and dose finding studies were done in advanced animal models at the Singapore Eye Research Institute.

About Eyecyte-RPE™
Eyecyte-RPE™ is a patented suspension of iPSC derived fate committed Retinal Pigment Epithelium cells which are highly potent, safe and efficacious in in-vitro and in-vivo studies. The cells are derived from induced pluripotent stem cells, are allogeneic in nature and can be stored for long periods of time.

About Eyestem Research
Headquartered in Bangalore and Delaware, Eyestem Research is a clinical stage biotechnology company which was started by a founding team with several decades of experience in pharmaceutical product development, ophthalmology and cell biology. It has won significant accolades with the most recent being named the top innovator in the country across all sectors in 2022 by the prestigious Economic Times newspaper. It is also the recipient of several prestigious grants from the Department of Biotechnology, Government of India and has been feted at high profile government functions as one of the most successful startups in the country. In addition to being backed by global investors in Switzerland and South Africa, it is backed by two of the most prestigious venture capital firms in the country- Kotak Investment Advisors and Endiya partners. Its most recent fund raise was backed by a consortium of three multi-billion dollar Indian pharmaceutical companies- Alkem Laboratories, NATCO and Biological E.

Read the news on The Economic Times

The COVID crisis brought into stark appearance the importance of pharma innovation, local manufacturing, and supply chain control to retain true independence of a nation. Countries such as Brazil, which did not have local manufacturing capabilities, ended up at the mercy of global pharmaceuticals, while India stood aatmanirbhar with a combination of core competence, resourcefulness, and, ultimately, political will. For us to continue to retain this aatmanirbharta, it is important for us to learn.

Read the news on The Economic Times

Bengaluru, India, February 2023: Eyestem, a Bengaluru-based Cell Therapy company, with a focus on Ophthalmology, has appointed Ravi Achar as Head- North America Strategy and also engaged Stradling as its US law firm.

Mr Achar has significant experience in the US start up ecosystem having successfully established fund raising and partnership strategies for several biotech companies.

Stradling, founded in 1975, is one of the top business law firms in the US based in Newport Beach, California. The firm provides a wide array of services with a stellar track record of seed, venture capital financing, M&A and IPOs in the Healthcare and Biotech space.

Dr Jogin Desai, Founder and Chief Executive Officer of Eyestem, said “As we get closer to getting human data for Eyecyte-RPE^TM, our lead product, we have been laying the groundwork for Eyestem’s global expansion through partnerships and strategic alliances. Mr Achar has a distinguished track record executing global alliances and we are delighted to have him on board as an experienced industry veteran.

The appointment of Stradling, a top law firm in the US biotech ecosystem, demonstrates our belief in the ability of our science to deliver superior patient outcomes at a global level.”

Eyecyte-RPE^TM, the company’s patented flagship product, is an experimental treatment for Dry Age-Related Macular Degeneration (Dry AMD). Eyecyte-RPE^TM replaces damaged retinal pigment epithelium cells and is designed to restore sight for patients in early stages of macular degeneration or arrest vision loss for those in later stages. The product is allogenic, administered by a proprietary surgical procedure and is patented internationally. The company is in consultation with CDSCO and the US FDA, intending to initiate clinical trials in the coming year.

Ravi Achar said "I am excited to join the Eyestem team and look forward to assisting in crafting a global strategy for the firm. Cell therapy has the ability to provide treatments for many currently incurable diseases in the coming years and I am privileged to be working with Eyestem to deliver on that promise.” Commenting on the engagement, Brent Reinke, Partner at Stradling said “We are excited to represent Eyestem and fully back their mission of creating Cell Therapy based products at scale which can address global markets and improve patient lives around the world.”

About Eyestem: Headquartered in Bangalore, India and Delaware, USA, Eyestem was founded by an experienced leadership team consisting of experts in regenerative medicine, ophthalmology and clinical research. Eyestem intends to be the benchmark for quality and affordability in cell therapies for targeted conditions. The company recently won the “Top Innovator in India” prize across all categories by the Economic Times and has been the recipient of several grants from the Department of Biotechnology, Government of India.

In 2021, Eyestem raised funding from leading pharma companies (Alkem Labs, NATCO, Biological E) and venture capitalists (Endiya Partners and Kotak Investments) in India. Additionally, it is also backed by marquee global investors such as Healthcrest Ventures (Zurich) and Church Street Trustees (South Africa).

The investment will enable Eyestem to progress a treatment for Dry Age-related Macular Degeneration to the clinic

Bengaluru, August 2022: Eyestem, a Bengaluru-based cell therapy company, has raised $6.4 million (INR 51 Crore) in a Series A round led by three pharma majors- Biological E. Limited (BE), Alkem, NATCO and Anurag and Karan Bagaria, promoters of Kemwell Biopharma. Existing investors Endiya Partners and Kotak Private Equity also participated in this round, valuing Eyestem at $46.4 million (INR 371 Crore) post money.

Dr Jogin Desai, Founder and Chief Executive Officer of Eyestem, said “We started Eyestem with the sole purpose of being able to create cell therapy products at scale for diseases that devastate a large number of people in India and the world. The support of major Indian pharma companies who share our vision endorses our strategy of developing affordable innovation for patients worldwide. Post this funding, we will remain focussed on solidifying our cell therapy platform and moving our flagship product for Dry AMD through early clinical trials of an international standard”.

Eyecyte-RPE^TM, the company’s patented flagship product, is an experimental treatment for Dry Age-Related Macular Degeneration (Dry AMD) and the company has other products in the pipeline for the treatment of incurable diseases affecting humanity. EyeCyte-RPE^TM replaces damaged retinal pigment epithelium cells and is designed to restore sight for patients in early stages of Macular Degeneration or arrest loss of vision for those in later stages. The product is allogenic, administered by a surgical procedure and is patented in India and abroad. The company intends to file for a first in human trial for the product within a year in consultation with CDSCO and US FDA.

Rajeev Nannapaneni, CEO, NATCO Pharma Limited, quoted "We are very happy to be associated with Eyestem for their innovative work that services unmet needs of patients that have high impact for quality of life".

Commenting on the fundraise, Dr. Ramesh Byrapaneni, Managing Partner of Endiya Partners said “Endiya partners is delighted to back such strong, globally competitive innovative start-ups and participate in the current funding round. The addition of leading pharma and biotech investors on our cap table is a great validation of the world class science that Eyestem is pursuing which can change millions of lives globally”.

Founded in 2016, by an experienced team of clinical research, regenerative medicine and ophthalmology experts, Eyestem is advised by a world-class Board and has built collaborations with other leaders in related scientific disciplines in India, UK, Japan and the United States. The long-term vision is to develop a scalable cell therapy platform to treat incurable diseases and democratize access to these newer technologies globally.

Read the news on The Economic Times

About Eyestem:
Headquartered in Bangalore and Delaware, Eyestem was founded by an experienced management team consisting of experts in clinical research, regenerative medicine and ophthalmology. Eyestem intends to be the benchmark for quality and affordability in cell therapies for targeted conditions. The company has received several prestigious awards and grants from the Department of Biotechnology, Government of India.

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Bengaluru, February 2022: Eyestem Research, India’s leading cell therapy company, announces the successful completion of itsdose ranging study in animals for Eyecyte-RPE^TM. Eyecyte-RPE^TM is a suspension of Retinal Pigment Epithelium Cells for treatment of Dry Age-Related Macular Degeneration. 170 M people worldwide suffer from this disease, 40 M of which are in India. Eyestem Research is one of the few companies in the world to develop such a treatment.

Commenting on the positive developments, Dr. Rajarshi Pal, Co-Founder and Chief Scientist, Eyestem Research, said, “We are thrilled to get a positive outcome from the dose ranging study with our collaborators in Oregon. When injected into an inherited rat model with retinal degeneration, Eyecyte-RPE^TM supported vision rescue demonstrated by a whole range of histological, functional and behavioral tests and helps retain the structural integrity of the host retina. These results will allow us to move forward with final manufacturing followed by toxicity studies and start human studies in the last quarter of 2022”.

“We are happy to have partnered with the Eyestem team for efficacy and safety studies of their RPE product. The current results re-affirm the results reported in 2018-19 and point to a precise roadmap for the final product formulation which would be optimum for efficacy and safety in humans. The Casey Eye team is delighted to have played a role in advancing this therapy which has tremendous potential to transform lives” commented Dr. Renee Ryals, Principal Investigator, Casey Eye Institute, Oregon Health and Science University.

“Over the next 10 years, diseases that were considered incurable will start becoming curable with the advance of cell and gene therapies. To ensure that the benefit of such therapies reaches the bottom 99 % of humanity, it is imperative to create a scalable cell therapy platform to help democratize access. Eyestem Research was purpose built around this mission and it gives me great pleasure to see us at the cusp of human trials for our flagship product” Commented Dr. Jogin Desai, Founder and CEO, Eyestem Research.

Founded by a highly experienced management team consisting of ophthalmology, regenerative medicine and clinical trial experts, Eyestem has created a platform for allogeneic, scalable cell therapy. While Eyecyte-RPE^TM, the company’s patented flagship product, is close to finding a treatment for Dry AMD, the company has two more products in the pipeline for Retinitis Pigmentosa and Idiopathic Pulmonary Fibrosis - similar incurable diseases affecting humanity. The company has received several awards and grants from the Department of Biotechnology, Government of India, published multiple papers in prestigious journals and has been awarded a patent for its unique protocol in India as well as the US.

Last year, the company received manufacturing approval for EyecyteRPE^TM from the Indian regulators and is in the process of manufacturing the product for confirmatory efficacy and toxicity studies in animals. First in man human clinical trials for Eyecyte-RPE^TM are currently scheduled for the last quarter of 2022.

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Bengaluru-based biotechnology company welcomes Endiya Partners as an investor. The company is poised to become one of the first companies in the world to develop a treatment for Dry AMD (Age-related Macular Degeneration), the largest cause of incurable blindness that affects nearly 170 million people worldwide Bengaluru, May, 2021: Eyestem, India’s leading cell therapy company, has raised funding from Endiya partners, one of India’s leading VC Funds in Technology, Healthcare and Life-sciences. This funding will allow Eyestem to move one step closer to scaling up its platform and creating affordable cell therapies which are essential in democratizing access to a large section of humanity. This investment will enable Eyestem to reach their goal of becoming one of the first few companies in the world to develop 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 highly experienced management team consisting of ophthalmology, cell therapy and clinical trial experts, Eyestem has created a platform for allogeneic, scalable cell therapy. Eyecyte-RPE^TM, the company’s patented flagship product, is close to finding a treatment for Dry AMD and the company has two more products in the pipeline for similar incurable diseases affecting humanity. The company has received several prestigious awards and grants from the Department of Biotechnology, Government of India. Last year, the company received manufacturing approval for Eyecyte-RPE^TM from the Indian regulators and is in the process of manufacturing the product for confirmatory efficacy and toxicity studies in animals. Phase 1 human clinical trials for Eyecyte-RPE^TM are currently scheduled for early 2022. Dr. Jogin Desai, Founder and CEO, Eyestem, said, “Endiya is one of the more seasoned investors in the medical space in India and we are thrilled to have them on board. There are 1.5 to 4 Crore people suffering from Dry Age-Related Macular Degeneration in India.  With our Eyecyte-RPE^TM cell-based therapy, we will soon be able to replace or repair damaged cells in the retina thereby helping address a previously incurable disease. I am looking forward to our clinical trials, scheduled towards early 2022, which will bring us closer to solving this global problem.” Indian investors are seeing a huge potential in this untapped market. “Healthcare, as we know it, is undergoing a transformation with new technologies providing treatment for diseases that have hitherto been deemed incurable. We are happy to be partnering with Dr Jogin Desai and the accomplished teams at Eyestem in their ambition to develop allogenic cell therapy products for such incurable diseases.We are particularly excited about the results we have seen in the product for treatment of Age-Related Macular Degeneration (AMD), a retinal degenerative disease” says Dr. Ramesh Byrapeneni, Managing Director, Endiya Partners.

About Endiya Partners:

About Eyestem:

Bengaluru-based biotechnology company raises second round of funding from Kotak Investment Advisors (Kotak Private Equity) and original investors. The company is poised to become one of the first companies in the world to develop a treatment for Dry AMD (Age-related Macular Degeneration), the largest cause of incurable blindness that affects nearly 170 million people worldwide Bengaluru, January 2020: Eyestem, India’s leading cell therapy company, has raised an undisclosed amount in funding from Kotak Private Equity and original investors towards taking Eyecyte-RPE^TM- its flagship product to treat Dry Age-related Macular Degeneration through first in man clinical trials. This round of investment was led by original global investors of the company in Switzerland, South Africa and India. In addition, Kotak Investment Advisors Limited, one of the largest and most reputed life sciences investor in the country, joined as a new investor. This investment will help Eyestem reach their goal of becoming one of the first few companies in the world to develop 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 highly experienced management team consisting of ophthalmology, cell therapy and clinical trial experts, Eyestem has created a platform for allogeneic, scalable cell therapy. Eyecyte-RPE^TM, the company’s patented flagship product, is close to finding a treatment for Dry AMD and the company has two more products in the pipeline for similar incurable diseases affecting humanity. The company has received several prestigious awards and grants from the Department of Biotechnology, Government of India. Last year, the company received manufacturing approval for Eyecyte-RPE^TM from the Indian regulators and is in the process of manufacturing the product for confirmatory efficacy and toxicity studies in animals. Phase 1 human clinical trials for Eyecyte-RPE^TM are currently scheduled for last quarter of 2021. Commenting on the positive developments, Dr. Jogin Desai, Founder and CEO, Eyestem, said, “Out of an estimated total of 170 million patients with Dry AMD, 1.8 million patients became totally blind in 2020. With our Eyecyte-RPE^TM cell-based therapy, we will soon be able to replace or repair damaged cells in the retina. I am looking forward to our clinical trials, scheduled towards the end of 2021, which will bring us closer to solving this global problem.” Indian investors are seeing a huge potential in this untapped market. “We are happy to be partnering with Dr Jogin Desai and team at Eyestem in their endeavour to develop allogenic cell therapy products addressing unmet medical needs. We are particularly excited about the results we have seen in the product for treatment of Age-Related Macular Degeneration (AMD) a retinal degenerative disease” says Nitin Deshmukh, Senior Advisor – Kotak Investment Advisors Ltd. Global investors remain committed to supporting Eyestem which is today well-positioned to be one of the leading companies of the cell therapy ecosystem. “The unique therapy platform developed by Eyestem will address an incurable disease that impacts millions of patients every year. Moreover, this solution is designed to democratize access to cell therapy due to its scalability and affordability. We believe Eyestem will disrupt the global cell therapy ecosystem, which is currently facing scale and pricing challenges,” agreed Gert Hoogland, CEO-Healthcrest AG and representing Jacesa Investments. Eyestem aims to create multiple cell-based products to help treat incurable diseases through its scalable cell therapy platform. Founded by experienced healthcare professionals and scientists, it is advised by an experienced global board and has collaborations with pioneer leaders in the space. Please visit www.eyestem.com for more information on the Eyestem platform and products. Contact: info@eyestem.com

Under this agreement, CCMB will use Eyestem’s human lung epithelial cell culture system provided as part of its Anti-Covid screening (ACS) platform to understand the molecular and pathological characteristics of the COVID-19 virus with a view to establishing a rational basis for testing potential drugs in vitro.

Commenting on the development, Dr. Rakesh Mishra, Director of CCMB, said “Culturing the virus outside the human host is a technological challenge that needs to be overcome. Eyestem’s cell culture system expresses the ACE2 receptor and other genes that are key determinants of viral entry and replication. We hope that employing this system will allow the CCMB team led by Dr. Krishnan Harshan to grow the virus predictably and thereby open up the potential for drug screening and vaccine development strategies”

Dr. Jogin Desai, CEO of Eyestem agreed and remarked “We are honoured to enter into this research collaboration with one of the premier scientific institutes in India. The ACS platform has been developed by Dr. Rajarshi Pal and his team and is a testament to our depth and expertise in cell therapy and disease modelling. We remain hopeful that CCMB will be able to leverage this platform and advance Covid research that will help humanity in India and abroad”

About CCMB The Centre for Cellular & Molecular Biology (CCMB), a premier research organization in frontier areas of modern biology is an autonmous laboratory under the Council for Scientific and Industrial Research.(CSIR) CCMB has responded to the current crisis and was the first academic laboratory outside ICMR to initiate COVID19 testing and kit validation. In addition, CCMB has intiated a variety of new research projects on SARS-CoV2.

About Eyestem Eyestem Research Private Limited is a cell therapy start-up incubated at the Centre for Cellular and Molecular Platforms, Bangalore. Its vision is to democratize access to cell therapy as well as disease modeling platforms and bring their benefit to a large section of humanity.

Eyestem has been selected to be part of the Centre for Cellular and Molecular Platforms (C-CAMP) Covid Innovation Deployment Accelerator (C-CIDA) and announces immediate availability of its Anti-Covid screening (ACS) platform using iPSC-derived lung progenitors. While any treatment modality including vaccines are 12-18 months away and the validity of antibody test are under debate, the shortest path to normalcy for the world is re-purposing of pre-approved drugs . The ACS platform, developed at Eyestem, provides the research community with a unique resource to determine efficacy of drugs/vaccines using the closest human host cell population.

Dr. Rajarshi Pal, Chief Scientist of Eyestem, commented “The ACS platform has been built upon lung stem cell work that has been done in our lab over the last 3 years. The launch of the platform is a credit to the depth of expertise of our scientists and their passion to contribute in solving this crisis”

Below is a list of frequently asked questions about our ACS platform.

1) What does the Anti-COVID Screening (ACS) platform consist of?

This ACS platform consists of three parts.

i) Cell lines: Frozen vials of airway (proximal lung) epithelial cells derived through a unique protocol that has been published and is patent pending.

ii) Expertise: We will work with our collaboration partners to help them thaw out and culture the frozen cells effectively and finally use them for screening purposes.

iii) Data sharing: We will share relevant characterization data with our collaboration partners which will help them in experimental design.

2) What is the genesis of the ACS platform?

The original genesis of the platform is based on a DBT- Stem Cells and Regenerative Medicine Task Force grant titled “Generation of airway progenitors from pluripotent stem cells by simulating milestones of in vivo lung development and their applicability for treatment of experimental pulmonary fibrosis” that I received in 2017 as Visiting Faculty, The University of Transdisciplinary Health Sciences and Technology, Bangalore. Owing to the immense translational potential of this project, over the last one year Eyestem invested into this area, thus expanding the scope of our lung research and resulted in a collaboration agreement with the Institute of Stem Cell and Regenerative Medicine (InStem, Bangalore) to study whether exogenously added lineage-traced lung progenitor cells will contribute toward the repair of the fibrotic lung in mouse models. When the COVID outbreak hit, we already had a small but very capable team working with hiPSCs (human Induced pluripotent stem cells) and lung cells and hence we decided to step-up and repurpose our efforts. Our goal is to get the relevant information out to the community and to share data as soon as possible, so that we can help accelerate ongoing efforts in the scientific and medical communities to fight the current COVID-19 crisis.

3) What are the details of the ACS platform?

a) What are the lacunae in existing screening strategies?

Since there is no effective way to address the threats of emerging mutant strains of COVID-19, the current de novo drug discovery and development pipeline is ineffective in dealing quickly with such a sudden viral outbreak. Repurposing existing drugs that may have unanticipated activities or rapidly developing newer vaccines as potential countermeasures against viral infections are two strategies being explored globally. Although several efforts are currently ongoing to study the repurposing potential of some pre-approved drugs, most studies are being carried out either in animal models or transformed cell lines wherein viral pathogenesis in human species is not faithfully mimicked. In addition, while a patient’s cell can directly model the effects of a drug on humans, their availability and capacity for expansion are limited compared to transformed or immortalized cells or tumour derived cell lines. The latter, however, may contain genetic and metabolic abnormalities due to their derivation, and thus would not represent a suitable drug screening model for human patients. These limitations present a significant obstacle that warrants the need for better models for studying drug efficacy, toxicity, and other host-targeted therapies.

b) What are the existing features of the ACS platform that can help fill the gap?

The entry of coronaviruses into the host lungs depends on the binding of the viral spike (S) proteins to cellular receptors and its priming by host cell proteases. This S protein mediates host cell invasion by SARS-CoV-2 via binding to a receptor protein called angiotensin-converting enzyme 2 (ACE2) located on the surface membrane of host cells. This invasion process requires S protein priming by the host cell-produced serine protease TMPRSS2. Notably we have shown upregulation of both ACE2 and TMPRSS2 in our iPSC-derived airway and alveolar epithelial cells grown in 2D cultures. If not naturally/endogenously expressed, one has to overexpress/engineer these crucial proteins on certain cell lines to facilitate COVID-19 infection (viral titer) which is not only complicated but also time consuming. Therefore, our in vitro model system is better suited for anti-viral screening and drug repurposing efforts.

c) What have we done so far?

Primary human lung alveolar epithelial cells are challenging to obtain and maintain in culture. We have successfully generated lung progenitors (Nkx2.1+) via definitive endoderm induction followed by anteriorized foregut endoderm formation. These proximal and distal lung progenitors have been shown to differentiate into airway epithelial and alveolar epithelial cells that can undergo freeze-thaw in 2D culture. Our published protocol recapitulates in vivo lung morphogenesis as demonstrated by the spatiotemporal expression of key transcription factors (SOX2, SOX9, FOXJ1) and protein markers (SFTPC, MUC5AC, CC10). The differentiation method is not very difficult to reproduce, easily scalable and is rapid (21-24 days).

d) What are we doing now?

Currently, this 2D protocol is being further expanded to culture these alveolar and airway cells at air-liquid interface (ALI). ALI culture will permit the exposure of SARS-CoV-2 to the apical surface of the cells. In parallel, we are working towards developing a three‐dimensional lung (bud) organoid model in collaboration with international labs.

4) What should interested parties do to set up a collaboration?

Please write to us at info@eyestem.com with a brief description of the collaboration you seek. Do ensure that you mention “COVID-19 collaboration” in the subject line of the email.

5) How much would it cost for us to use the platform?

Given the current crisis, Eyestem is willing to deploy this platform at research centres of repute who have access to the virus and the requisite BSL3 infrastructure at minimal cost.

Any private entity that would like to deploy the platform should get in touch with us for further discussions.

6) Can you provide us some references for the work done?

1. Surendran HS, Mohanapriya R, Pal R. Differentiating induced pluripotent stem cells into lung epithelial cells. 2019. Curr Protoc Stem Cell Biol 49(1):e86.

2. Banerjee P, Surendran H, Bharti K, Morishita K, Varshney A, Pal R. Long non-coding RNA RP11-380D23.2 drives distal-proximal patterning of the lung by regulating PITX2 expression. 2018. STEM CELLS. 36(2): 218-229.

3. May-Simera HL, Wan Q, Jha BS, Hartford J, Khristov V, Dejene R, Chang J, Patnaik S, Lu Q, Banerjee P, Silver J, Insinna-Kettenhofen C, Patel D, Lotfi M, Malicdan M, Hotaling N, Maminishkis A, Sridharan R, Brooks B, Miyagishima K, Gunay-Aygun M, Pal R, Westlake C, Miller S, Sharma R, Bharti K. Primary Cilium Mediated Retinal Pigment Epithelium Maturation is Disrupted in Ciliopathy Patient Cells. 2018. Cell Reports 22(1): 189-205.

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.

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Bengaluru-based start-up to take its flagship product, Eyecyte-RPE^TM, 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^TM, 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^TM, 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.

Dhanusha Sasidharan | Lokesh Kumar

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 Eyecyte-RPE^TM: our lead product for treatment of Dry AMD (macular degeneration) As per Dr.McGill "Eyecyte-RPE^TM 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 Eyecyte-RPE 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.