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Paris, France, and Cambridge, Mass., United States, October 05, 2020 – Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today announced the U.S. Food and Drug Administration (FDA) has granted an orphan-drug designation (ODD) for EYS611 for the treatment of retinitis pigmentosa (RP).  

Eyevensys is developing EYS611, a DNA plasmid that encodes for the human transferrin protein, to benefit patients diagnosed with RP, as well as other degenerative retinal diseases, including late stage, dry age-related macular degeneration and glaucoma.  

Transferrin is an endogenous protein that helps manage iron levels in the eye. While iron is essential for retinal metabolism and the visual cycle, excessive iron can induce oxidative stress and is extremely toxic to the retina. Iron overload has been associated with photoreceptor death in several retinal degenerative diseases. By acting as an iron chelating and neuroprotective agent, EYS611 helps slow the progression of diseases like RP regardless of the specific genetic mutation causing the condition.  

Eyevensys just reported data from preclinical testing in the September 2020 issue of the journal Pharmaceutics. The paper, entitled “Transferrin non-viral gene therapy for treatment of retinal degeneration” (Bigot, et al., Pharmaceutics), shows that EYS611 is safe and effective for preserving photoreceptors and retina functionality in acute toxicity and inherited rat models of retinal degeneration. 

“We are delighted to have received orphan-drug designation from the FDA as it is an important regulatory milestone. We look forward to translating our unique non-viral gene therapy program to patients with RP, to slow the progression of this degenerative retinal disease with no currently approved treatment that compromises patients’ vision and eventually lead to blindness,” said Thierry Bordet, PhD, Chief Scientific Officer.  

“This orphan-drug designation acknowledges the unmet needs of individuals suffering from RP, and this opportunity to move our therapy through the development process with this designation is an encouraging milestone. With EYS611, we are optimistic we will advance a therapeutic option for all patients with RP independent of the underlying genetic mutation that is much less invasive and can be used to treat patients at an earlier stage of disease than traditional viral vector gene replacement therapies that target only the macula and are being developed only for a select handful of RP patients with specific mutations,” said Ronald Buggage, MD, Eyevensys’ Chief Medical Officer.  

The FDA’s Orphan Drug Designation Program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.  

About Eyevensys 

Eyevensys is a privately held, clinical-stage biotechnology company developing its innovative technology to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic diseases. 

The Eyevensys technology, developed by Pr. Francine Behar-Cohen, uses electroporation to deliver proprietary DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye. This approach induces the sustained intraocular production of therapeutic proteins. 

Eyevensys’ lead product EYS606 is a potential new treatment for patients with chronic non-infectious uveitis (NIU). EYS606 combines Eyevensys’ proprietary Electrotransfection System with plasmids encoding for the production of a potent fusion protein which neutralizes the activity of TNFα, a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU. EYS606 is currently in a phase I/II clinical trial in the EU and has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU. The therapeutic potential of EYS606 in patients with active, chronic NIU is being further investigated in Part 2 of the ongoing EYS606-CT1 study in the EU and in a second phase 2 trial, the Electro Study (EYS606-CT2) being conducted in the US. 

Additionally, Eyevensys is developing EYS611, a treatment for Retinitis Pigmentosa and potentially other retinal degenerative conditions including the later stages of Dry AMD and glaucoma. The treatment encodes for a potent iron chelator with antioxidant and endogenous neuroprotective properties. In animal models, the treatment has been shown to be safe and effective at preserving and slowing the degeneration of retinal structure and function. 

Eyevensys is also advancing a dual gene plasmid, EYS809, expressing two therapeutic proteins for wet AMD, diabetic macular edema, and central retinal vein occlusion, and it is exploring further compounds for undisclosed indications. 

Eyevensys was founded in 2008. The company has offices in Paris, France and the U.S. The company is funded by the Boehringer Ingelheim Venture Fund, Pureos Bioventures, Bpifrance through the Innobio Fund, CapDecisif, Inserm Transfert Initiative, Pontifax and the Global Health Sciences Fund. 

For more information about Eyevensys, please visit www.eyevensys.com. 

Media Relations Contact:
Marion Janic, RooneyPartners
[email protected]
+1-212-223-4017 

1. Gerald Cagle, Ph.D. named Chairman of the Board
2. Francine Behar-Cohen, M.D., Ph.D. named Chief Innovation Officer
3. Thierry Bordet, Ph.D. named Chief Scientific Officer

Paris, France, and Fort Worth, Texas, United States, March 10, 2020 – Eyevensys, a privately held clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today announced the expansion of its leadership team with the appointment of Gerald Cagle as the Board’s Chairman, Francine Behar-Cohen to Chief Innovation Officer and Thierry Bordet as the Chief Scientific Officer.

Dr. Cagle, who joined Eyevensys’ Board of Directors in 2018, was the former Senior Vice President and Chief Scientific Officer at Alcon Laboratories, the world’s largest eye care device company. He  will replace Dr. Garth Cumberlidge, the company’s current Chairman. Dr. Cagle will work closely with and advise Dr. Patricia Zilliox, Eyevensys’ CEO, in strategic decision making for the company.Dr. Cagle said, “I am looking forward to working even closer with the Eyevensys management team to help it achieve its next level of growth and I am truly honored to lead such an extraordinary Board as its Chairman.”

Eyevensys founder and previous Chief Scientific Officer, Pr. Behar-Cohen will assume the role of Chief Innovation Officer – a newly created position at the company. “Within the next 10 years, gene therapies will be accepted treatments for both rare genetic retinal conditions and more common eye diseases and patients will be able to have treatments based on their own specific genetic profiles. Eyevensys is at the forefront of creating technologies that will be best-in-class to treat and prophylactically prevent future ocular maladies,” Pr. Behar-Cohen said.    

Dr. Thierry Bordet has been promoted to Chief Scientific Officer, from his previous position as Pre-Clinical Director for the company. Prior to coming to Eyevensys in 2017, Dr. Bordet had over 15 years of experience in the biotechnology sector having managed drug development programs for small molecules, gene therapies, cell-based therapies and tissue engineered products. He was most recently Pre-Clinical Development Director at the Biotherapies Institute for Rare Diseases, in Evry, France where he designed development strategies for advanced therapy medicinal products for various indications, including inherited retinitis pigmentosa.

About Eyevensys

Eyevensys is a privately held, clinical-stage biotechnology company developing its innovative technology to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic diseases.

The Eyevensys technology, developed by Pr. Francine Behar-Cohen, uses electroporation to deliver improved proprietary DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye. This approach facilitates the sustained intraocular production of therapeutic proteins.

Eyevensys’ lead product EYS606 is a potential new treatment for patients with chronic non-infectious uveitis (CNIU). EYS606 combines Eyevensys’ proprietary Electrotransfection System with plasmids encoding for the production of a potent fusion protein which neutralizes the activity of TNFα, a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU. EYS606 is currently in a phase I/II clinical trial in the EU and has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU. The therapeutic potential of EYS606 in patients with active, chronic NIU will be further investigated in Part 2 of the ongoing EYS606-CT1 study in the EU and in a second phase 2 trial, the Electro Study (EYS606-CT2) that will be launched in the U.S. in early 2020.

Additionally, Eyevensys is developing EYS611, a treatment for Retinitis Pigmentosa and later stages of Dry AMD. The treatment encodes for a potent iron chelator with antioxidant and endogenous neuroprotective properties. In animal models, the treatment has been shown to be safe and effective at preserving the retina in the wake of both conditions.

Eyevensys is also advancing a third compound, EYS809, for wet AMD, diabetic macular edema, and central retinal vein occlusion, and it is exploring further compounds for undisclosed indications.

Eyevensys was founded in 2008. It is headquartered in Paris, France, and operates a wholly-owned U.S. subsidiary out of Fort Worth, Texas. The company is funded by the Boehringer Ingelheim Venture Fund, Pureos Bioventures, Bpifrance through the Innobio Fund, CapDecisif, Inserm Transfert Initiative, Pontifax and the Global Health Sciences Fund.

For more information about Eyevensys please visit www.eyevensys.com.

Media Relations Contact:
Marion Janic, RooneyPartners
[email protected]
+1-212-223-4017 

Eyevensys announced today that it has completed a $30 million Series B financing. The round was led by Boehringer Ingelheim Venture Fund and included participation from existing investors Pontifax, Bpifrance, CapDecisif, and Inserm Transfert, as well as new investors, the Global Health Sciences (GHS) Fund (Quark Venture LP and GF Securities) and Pureos Bioventures. 

The company will use the funds to continue the development of its clinical lead candidate EYS606 for the treatment of chronic non-infectious uveitis (NIU), including the launch of its Electro Study. This Phase 2 trial, to be conducted in the U.S., will evaluate the safety and efficacy of EYS606 in patients with active forms of all anatomic uveitis subtypes. The funding will also advance the preclinical development of its other therapeutic proteins targeting ophthalmic diseases with unaddressed medical needs such as retinitis pigmentosa and age-related macular degeneration (AMD). EYS606 is currently in a phase I/II clinical trial in the EU and has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU. 

In conjunction with the financing, Eyevensys has added to its Board of Directors. Neena Kadaba, PhD, Director of Science at Quark Venture LP, joined the board, as well as Dominik Escher, PhD, Managing Partner at Pureos Bioventures, and former founder and CEO of ESBATech, an ophthalmology biotech company acquired by Alcon in 2009, which developed the recently approved Beovu, a new treatment for wet age-related macular degeneration. 

Eyevensys has also recently opened a wholly-owned U.S. subsidiary in Fort Worth, Texas. All U.S. operations will be managed from this location, though the Eyevensys headquarters will remain in Paris. 

The Eyevensys technology is a non-viral gene therapy ocular drug delivery platform that uses an Electrotransfection System to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle. This turns the eye into a biofactory, allowing the ciliary muscle to express and secrete the therapeutic protein to the back of the eye at therapeutic levels for a duration of greater than 6 months. 

Dr. Patricia Zilliox, Chief Executive Officer, said, “We are thrilled to have completed this Series B funding round with the strong support from both existing and new investors for the company. This funding will assist the further development of our technology and position Eyevensys as an innovator in the field of ophthalmology.” 

She continued: “As we launch the Electro Study, our first U.S. clinical trial, Eyevensys will also have an opportunity to connect with ophthalmology opinion leaders in the U.S. to gain further exposure for our groundbreaking technology platform. This will also move the company one step closer to providing a more effective and convenient treatment approach to ease the burden of managing patients with chronic ocular conditions.” 

About Eyevensys 

Eyevensys is a privately held, clinical-stage biotechnology company developing its innovative technology to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic diseases. 

The Eyevensys technology, developed by Dr. Francine Behar-Cohen in Paris, uses electroporation to deliver improved proprietary DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye. This approach facilitates the sustained intraocular production of therapeutic proteins. 

Eyevensys’ lead product EYS606 is a potential new treatment for patients with chronic non-infectious uveitis (NIU). EYS606 combines Eyevensys’ proprietary Electrotransfection System with plasmids encoding for the production of a potent fusion protein which neutralizes the activity of TNFα, a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU. EYS606 is currently in a phase I/II clinical trial in the EU and has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU. The therapeutic potential of EYS606 in patients with active, chronic NIU will be further investigated in Part 2 of the ongoing EYS606-CT1 study in the EU and in a second phase 2 trial, the Electro Study (EYS606-CT2) that will be launched in the US in early 2020. 

Additionally, Eyevensys is developing EYS611, a treatment for Retinitis Pigmentosa and Dry AMD. The treatment encodes for a potent iron chelator with antioxidant and endogenous neuroprotective properties. In animal models, the treatment has been shown to be safe and effective at preserving the retina in the wake of both conditions. 

Eyevensys is also advancing a third compound, EYS609, for wet AMD, diabetic macular edema, and central retinal vein occlusion, and it is exploring further compounds for undisclosed indications. 

Eyevensys was founded in 2008. It is headquartered in Paris, France, and operates a wholly-owned U.S. subsidiary out of Fort Worth, Texas. The company is funded by the Boehringer Ingelheim Venture Fund, Pureos Bioventures, Bpifrance through the Innobio Fund, CapDecisif, Inserm Transfert Initiative, Pontifax and the Global Health Sciences Fund. 

For more information about Eyevensys please visit www.eyevensys.com. 

Media Relations Contact: 

Marion Janic, RooneyPartners 

[email protected]

+1-212-223-4017