Our Mission is to develop and commercialize innovative ophthalmic products to enable optimal vision and better quality of life for all patients.
Pipeline products are investigational products for which the safety and efficacy have not been established. There is no guarantee that these products will be approved by FDA for their proposed use or become commercially available.
(sterile vancomycin ophthalmic ointment) 1.1%
(topical ophthalmic gel)
Persistent Epithelial Defect (“PED”) – resulting from Chemical or Thermal burns
In September of 2018, Eyevance in-licensed world-wide rights for NEXAGON® from OcuNexus Therapeutics, Inc. NEXAGON® is being developed as a topical ophthalmic treatment of persistent epithelial defect secondary to chemical/thermal injury to the eye.
The active pharmaceutical ingredient (API) in NEXAGON® is a short, 30-base antisense oligonucleotide of single-stranded DNA identified as CODA001, that has not been chemically modified. The CODA001 oligonucleotide sequence is complementary to a portion of human mRNA that encodes a protein known as “connexin43”, the most ubiquitous human connexin protein. Connexin43 is the constituent protein of “gap junctions”, an intercellular communication conduit found in most animal cell types. Each gap junction channel is composed of two hemichannels, one contributed by each of the neighboring cells. Hemichannels migrate to the plasma membrane and need to remain closed prior to docking with a hemichannel from an adjacent cell.
Uncontrolled hemichannel opening forms a large, poorly selective, pathological pore in the cell membrane. After serious injury and in chronic wounds, uncontrolled connexin43 hemichannel opening results in inflammation through activation of the inflammasome pathway and loss of vascular integrity, facilitating increased tissue damage. Further, in chronic wounds, inflammation and uncontrolled connexin43 hemichannel opening perpetuates the inflammasome cycle and associated cytokine release.
When CODA001 is applied directly to a wound it transiently hybridizes to connexin43 mRNA, temporarily inhibiting local expression of connexin43 resulting in temporary inhibition of hemichannel formation. This mechanism-of-action of CODA001 has been demonstrated in animal models to reduce inflammation, loss of vascular integrity, edema, and fibrosis, resulting in tissue healing and regeneration.
Eyevance will be starting a Phase 2b/3 clinical trial for NEXAGON® in 3Q 2020. Additionally, eyecare professionals with patients exhibiting persistent epithelial defects that may possibly benefit from the application of NEXAGON® will be able to request access to NEXAGON® through an Individual Patient Expanded Access – Investigational New Drug Application (IND).
To learn more, watch the video below.
If you’re interested in learning more about the Individual Patient Expanded Access Application for NEXAGON®, please contact us.
In December of 2017, Eyevance acquired US rights to vancomycin hydrochloride ophthalmic ointment 1.1% (vancomycin ointment) from Perrigo® Pharmaceuticals. Eyevance has completed a Phase 3 clinical trial of vancomycin hydrochloride ophthalmic ointment 1.1% as a topical ophthalmic antibiotic ointment being investigated for the treatment of ocular infections, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-resistant Staphylococcus epidermidis (MRSE).
Ocular infections increasingly fail to respond to empiric treatment with approved antibiotics. In many cases, these infections are caused by MRSA or MRSE. Surveillance studies have demonstrated that methicillin resistance is a marker for multidrug resistance to ≥4 drug classes, including fluoroquinolones. When ocular infections due to MRSA/MRSE do not respond to empiric treatment with approved antibiotics, there are few choices for an alternative therapy. In almost all cases, the multidrug resistant infectious organisms are susceptible to vancomycin.
Currently there is no approved ocular formulation of vancomycin in the United States, so it must be compounded. Compounded vancomycin is toxic to the ocular surface and has a limited shelf-life due to its instability in aqueous solutions. Vancomycin hydrochloride ointment 1.1% was approved by Japan’s Pharmaceuticals and Medical Devices Agency, in 2009 for the treatment of ocular infections due to MRSA and MRSE strains susceptible to vancomycin.
In summary, the efficacy, safety, pharmacokinetic, and stability profile of vancomycin ointment 1.1%, combined with the unmet medical need for a stable, effective, and safe treatment of ocular MRSA/MRSE infections supports the development of vancomycin ointment 1.1% in the United States.
Eyevance will be meeting with the FDA in 3Q 2020 to discuss the results of the Phase 3 study.