Therapy Areas: Infectious Diseases
Eyevensys Presents Initial Data from Phase I/II Trial of Innovative, Non-Viral Gene Therapy for Ocular Diseases at 11th Annual Ophthalmology Innovation Summit
18 October 2019 - - US-based biotechnology company Eyevensys has presented results from part 1 of its phase I/II study for non-infectious uveitis at the Ophthalmology Innovation Summit's 11th Annual OIS@AAO conference on October 10, 2019 in San Francisco, the company said.

Dr. Ronald R. Buggage, MD, chief medical officer of Eyevensys, discussed the novel technology during the Gene and Cell Therapy Spotlight session.

The company's technology is a non-viral gene therapy ocular drug delivery platform that uses a two-part Electrotransfection System, including a proprietary Ocular Device and Electrical Pulse Generator, that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle.

This turns the eye into a biofactory, allowing the ciliary muscle to produce the therapeutic protein. The secreted protein reaches the back of the eye, including the retina and choroid.

Eyevensys has successfully completed part 1 of a clinical safety study of its lead product EYS606, a non-viral vector encoding an anti-TNFα protein.

Tumor necrosis factor alpha is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation. The trial enrolled nine patients (three patients per cohort) with late-stage, NIU in France and the UK.

The study revealed no serious adverse events related to the Eyevensys technology and the overall early safety profile was similar to that of other intraocularly administered ophthalmic treatments.

Despite their advanced disease stage at enrollment, three of the 9 patients treated with EYS606 showed clinical improvements lasting for six months after one administration of the treatment.

The first patient treated in the lowest dose cohort experienced a >10 ETDRS letter improvement in best corrected visual acuity while two patients treated in the highest dose cohort showed a significant reduction of macular edema via optical coherence tomography associated with at least +12 ETDRS letters increase in BCVA from baseline.

An investigational new drug application was filed in July 2019 and subsequently cleared with the US Food and Drug Administration in August 2019.

This IND allows Eyevensys to further validate the technology in a phase II clinical study targeting patients with active chronic NIU.

In parallel, Eyevensys is also advancing preclinical programmes using different proteins for other ophthalmic diseases, including retinitis pigmentosa, dry AMD, glaucoma, macular edema associated with wet-AMD, DME, and CRVO.

Eyevensys is a private clinical stage biotechnology company developing its innovative technology to enable the sustained intraocular production of therapeutic proteins to treat a 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 intra-ocular production of therapeutic proteins.

Eyevensys' lead product EYS606 is a potential new treatment for patients with chronic non-infectious uveitis.

EYS606 combines Eyevensys' proprietary Electrotransfection System with plasmids encoding for the production of a potent fusion protein which neutralises 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 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 the Phase 2 EYS606-CT2 (Electro) Study that will be launched in the US in early 2020.

Eyevensys was founded in 2008. It is headquartered in Paris, France, incorporated in the US, and is funded by Boehringer Ingelheim Venture Fund, BPIFrance, CapDecisif, Inserm Transfert, Pontifax and GHS.


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