Omnigen VIEW-range (Professional Treatment Use Only). NuVision Biotherapies Ltd
- Formulation
-
- Tereo® processed amniotic membrane:
- Overcomes known challenges by retaining the natural integrity and qualities of fresh amniotic membrane that aid ocular healing in an accessible and easy to use product
- Improved retention of the amniotic membrane barrier function
- Stable on the shelf
- Storage between 2ºC to 25ºC for ease of access
- Rehydration in vivo
- Easy application and manipulation
- Protected integrity and quality and consistency and function
- 17mm disc with 6mm aperture.
- Suppliers
- NuVision Biotherapies Ltd.
- How supplied
- Single sterile amniotic membrane shipped and stored between 2ºC to 25ºC.
- Dosing
- ECP to decide.
- CL Use
- Yes, see Note 5.
- Indications
- Suture-free transplantation of Omnigen means patients benefit from the barrier function of Omnigen without the need for surgery. Suture-free transplantation of Omnigen is suitable for a range of applications". Omnigen is a dry and stable human amniotic membrane-derived material. Amniotic membrane can be used to aid the natural healing process in ophthalmic conditions and soft tissue-damage situations. Applied to the wound dry for in-vivo rehydration. Ready for use at point-of-care. Accessible in an outpatient setting by ambulatory application. Key benefits of amniotic membrane’s barrier function allow its transplantation to: Help reduce inflammation development and progression, Provide a protective and supportive environment to facilitate natural healing and recovery, Physically alleviates pain by protecting the ocular surface, Physically prevents the development of adhesions
- Contra-Indications / Cautions
- Hypersensitivity to product/class/component. Pregnancy/lactation - EDDB. Advise pt to avoid all water coming into contact with lens. "OmniLenz may not be suitable for use in patients who exhibit abnormal blinking, excessive eye rubbing or who are unable to give informed consent". "Compliance with Human Tissue Authority (HTA) regulations ambulatory transplantation of Omnigen® using OmniLenz® is considered a human tissue transplantation procedure, therefore use of Omnigen® and OmniLenz® should comply with traceability requirements within your territory. OmniLenz® is a CE marked product and should be used in line with the instructions for use. Activity recording involving the application of Omnigen with OmniLenz in the United Kingdom will be based on two NHS OPCS codes: C46.6: Amniotic membrane graft to cornea and C51.5: Placement of therapeutic contact lens on to cornea.". Under no circumstances should a patient or lay person touch, remove or attempt to re-apply the lens or amniotic patch.
- Adverse Reactions
- If patients experience eye discomfort, excessive tearing, vision changes, redness of the eye or other problems are experienced, they should be instructed to promptly contact their Eye Care Professional. If vision changes or irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP.
- Legal Category
- Rx only.
Notes:
1. ON NO ACCOUNT SHOULD THE DATA CONTAINED ON THIS PAGE BE USED AS A BASIS FOR CLINICAL DECISION MAKING - THIS SHOULD ONLY BE DONE BY REFERENCE TO THE ORIGINAL PRESCRIBER AND/OR PRODUCT DOCUMENTATION.
2. Because products are regularly improved and change, product data and advice may occasionally change. As a result, EDDB recommends that you and your patient always read the product label and Patient Information Leaflet carefully before using any products. Please do not solely rely on the information provided on this website. Because of this, EDDB is unable to accept liability for any inaccuracies or incorrect information contained on this site.
3. SUBSITUTION OF LENSES OR CHANGES TO THE CONTACT LENS PRESCRIPTION/PARAMETERS SHOULD ONLY BE AUTHORISED BY THE ORIGINAL PRESCRIBER OR THE OPTOMETRIST/CONTACT LENS OPTICIAN/DOCTOR ASSUMINGRESPONSBILTY FOR THE PATIENT - EDDB.
4. THIS PRODUCT MUST ONLY BE ADMINISTERED TO A PATIENT BY AN APPROPRIATELY TRAINED QUALIFIED ECP.
5. The Omnigen VIEW-range must only be used in conjunction OmniLenz. "OmniLenz® is a bandage contact lens (BCL) that allows suture-free transplantation (onlay-barrier application) of Omnigen to the ocular surface in an ambulatory and outpatient setting.
6. Click to view OmniLenz Data Page.
8. Omnigen-OmniLenz in Dry eye disease patients: https://www.dovepress.com/article/download/92615
9. The ambulatory application of Omnigen with OmniLenz https://www.nu-vision.co.uk/omnilenz/
| Name | File | |
|---|---|---|
| Royal College of Ophthalmology Poster. | RCOph_-_poster_STH.pdf | |
| Incident Reporting Form. | D-Q12a-v07-Incident-Report-Form-.pdf | |
| Omnigen Orientation guide. | Omnigen-Orientation-Guide-v04.pdf |
