Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today provided highlights from the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference held in Denver, Colorado. In addition to its participation in the event, Eyevensys also held a successful meeting with principal investigators involved in its clinical trials evaluating EYS606, a plasmid DNA encoding an anti-TNFa protein for non-infectious uveitis (NIU).
Principal investigators, including the study's coordinating investigators, reviewed data from two clinical trials, a Phase I/II and a Phase II called ELECTRO, conducted in NIU subjects. These studies were designed to demonstrate, for the very first time in humans, the safety of plasmid administration into the ciliary muscle using Eyevensys' proprietary Electrotransfection Platform. These two studies treated 18 subjects. There were 15 subjects with late-stage disease who were treated in France and the United Kingdom, and three subjects with active NIU who were treated in the United States.
Overall, several subjects showed biological activity post EYS606 treatment. This includes two out of the three US subjects whose disease signs and symptoms improved after treatment with EYS606. Dr. Srivastava, a uveitis Key Opinion Leader, qualified these two improvements as non-expected for this disease population and related to the EYS606 treatment. Furthermore, no circulating anti-drug antibodies (ADA) against the anti-TNFa protein were reported suggesting an absence of any immune reaction.
In a separate meeting, the DSMB members concluded that no safety concerns were associated with the EYS606 plasmid or the Eyevensys Electrotransfection Platform.
These first-in-human studies allowed Eyevensys to collect information enabling optimization of the platform, which includes an ocular device and an electrical pulse generator.
The design optimization was done in collaboration with medical device manufacturers Phillips-Medisize and Minnetronix Medical, and medical device designer Kaleidoscope.
"We are especially pleased about these positive clinical trial results," said Patricia Zilliox, Chief Executive Officer at Eyevensys. "These results provide strong evidence that our electrotransfection platform has the potential to treat other retinal diseases such as wet and dry AMD with less frequent treatments."
During the conference Pr. Francine Behar-Cohen, Founder and Chief Innovation Officer of Eyevensys presented a paper that highlighted EYS809, the Company's promising candidate for wet AMD subjects. As part of her abstract presentation, Pr. Behar-Cohen discussed the fact that subretinal fibrosis, favored by recurrence of exudation, leads to irreversible vision loss in wet AMD subjects. Specifically, she spoke about the effect of Decorin (DCN) on choroidal neovascularization (CNV) fibrosis and epithelial-mesenchymal transition (EMT) in a rat model of CNV. Her results concluded that DCN is a promising candidate for wet AMD subjects on top of anti-VEGFs therapies.
"Eyevensys is developing EYS809, a DNA plasmid that encodes for aflibercept and decorin, to benefit subjects diagnosed with wet AMD, a chronic eye disorder that causes blurred vision or a blind spot in the visual field. The abstract presented showed that DCN reduces the volume of established CNV and its fibrotic scarring. This adds to the growing evidence in support of the EYS809 candidate," said Dr. Behar-Cohen.
Eyevensys' unique non-viral gene therapy platform provides a wide range of treatment options with the potential to address a variety of ophthalmic diseases, both rare and common, some with no previously approved treatment. During the conference, Eyevensys also presented two poster presentations that evaluated the protective effects of Transferrin, another asset of the company, on various ex vivo and in vivo models of dry AMD and glaucoma.
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 is advancing a dual gene plasmid, EYS809, expressing two therapeutic proteins, a potent VEGF inhibitor and an endogenous protein with anti-angiogenic and antifibrotic properties for the treatment of wet AMD which also has the potential be a treatment for diabetic retinopathy, diabetic macular edema and central retinal vein occlusion.
Eyevensys is also developing EYS611, a treatment for the later stages of dry AMD and for retinitis pigmentosa and potentially other retinal degenerative conditions including 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 slowing the degeneration of retinal structure and preserving function. EYS611 has been granted Orphan drug designation for the treatment of retinitis pigmentosa in the EU and in the US.
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, Karista, Inserm Transfert Initiative, Pontifax, Global Health Sciences Fund, and Korean Investment Partners.
For more information about Eyevensys, please visit www.eyevensys.com.
Eyevensys is open for discussions for co-development or licensing opportunities.
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