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Allergan acquires Oculeve

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  • Allergan acquires Oculeve

    I read about this company and device 6 months ago (https://med.stanford.edu/news/all-ne...e-dry-eye.html) and was VERY excited about it. Apparently Allergan is too. They intend to do 2 more trial phases by the end of 2016 with proposal for FDA approval in 2017 if those are successful. I am holding my breath on this one as it looks awesome

    Allergan to Acquire Medical Device Company Oculeve
    By Pharma News posted Mon, Jul 06, 2015 12:10 PM
    Allergan plc (formerly known as Actavis) has agreed to acquire Oculeve, a development-stage medical device company focused on developing treatments for dry eye disease in an all-cash transaction. Under the agreement, Allergan will acquire Oculeve for a $125 million upfront payment and commercialization milestone payments related to Oculeve's lead development program OD-01. The agreement also includes the acquisition of an additional earlier-stage dry-eye device development program.

    The acquisition of Oculeve adds complementary dry-eye development programs to Allergan's current eye-care research and development programs, including OD-01, a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease. Oculeve has completed four clinical studies of OD-01 to date in more than 200 patients, showing positive safety and efficacy of the device. Allergan plans to conduct two additional pivotal trials prior to submission to the US Food and Drug Admnistration, which is expected in 2016 with potential commercial launch in 2017. /p>

    Chronic dry eye is a disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. One type of chronic dry eye is caused by decreased tear production due to inflammation. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea. Chronic dry eye is estimated to affect 25 million patients in the US, according to information from Allergan.

    The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Pending approvals, Allergan anticipates closing the transaction in the third quarter of 2015.

    Allergan is the new corporate name following the approximately $70 billion acquisition of Allergan by Actavis, in a deal that was announced in 2014 and closed in March 2015. In June 2015, Actavis announced that the combined company would use Allergan as its corporate name, and the Actavis name would continue to be used for the company's US and Canadian generics businesses.

  • #2
    I am confused about the current status of the device. On the DryEyeTalk Facebook page a member said it is already approved in Australia, Canada and Europe but he wasn't able to give me the details of the contact he had at Oculeve so I emailed their general enquiries address and haven't had a response. I read somewhere that trials had been carried out in the UK already but of course I can't find the link now. My Ophthalmologist was interested in carrying out a clinical trial in the UK. Can anyone shed any light on this?

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    • #3
      Originally posted by lizlou29 View Post
      I am confused about the current status of the device. On the DryEyeTalk Facebook page a member said it is already approved in Australia, Canada and Europe but he wasn't able to give me the details of the contact he had at Oculeve so I emailed their general enquiries address and haven't had a response. I read somewhere that trials had been carried out in the UK already but of course I can't find the link now. My Ophthalmologist was interested in carrying out a clinical trial in the UK. Can anyone shed any light on this?
      This trial mentions those studies : https://med.stanford.edu/news/all-ne...e-dry-eye.html.

      I am not sure how approval works in those countries but we can look at clinical trials.gov in the US to see the current status of testing and check with Our FDA about approval and availability. Do you have similar options where you are?

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      • #4
        It looks like the locations of the other studies are Australia, new Zealand and Mexico. Here is the Australia /new Zealand clinical trial link:https://www.anzctr.org.au/Trial/Regi...aspx?id=364955

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        • #5
          It doesn't look like it has been approved in Europe yet:http://www.european-biotechnology.net/. The stocks I read said it will seek approval in Canada and EU in the near future. On the social media website, Linked In, you can find many of the people working for Oculeve. You could inquire with them about status? Their website doesn't really seem to have ever worked when I try to go to it...
          Last edited by Amanda; 08-Jul-2015, 00:47.

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          • #6
            Thanks Amanda for all the info. I am going down the LinkedIn route to try and track people down at the moment! Have tried to contact one of the doctors involved in the study through the clinic she works at but they were unhelpful and wouldn't forward my email onto her, they would only communicate with me regarding appointments Basically I just need an answer as to whether they plan on conducting more UK trials and to put them in touch with my Ophthalmologist. I'm wondering if Allergan acquiring Oculeve has changed the way they are going to go forward with trying to get the device to the market.

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            • #7
              Originally posted by lizlou29 View Post
              Thanks Amanda for all the info. I am going down the LinkedIn route to try and track people down at the moment! Have tried to contact one of the doctors involved in the study through the clinic she works at but they were unhelpful and wouldn't forward my email onto her, they would only communicate with me regarding appointments Basically I just need an answer as to whether they plan on conducting more UK trials and to put them in touch with my Ophthalmologist. I'm wondering if Allergan acquiring Oculeve has changed the way they are going to go forward with trying to get the device to the market.
              I definitely want to see about getting into one of the US trials! Keep me posted on what you find out!

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              • #8
                I want in a trial too or to purchase the device when it comes to market. Sounds just like what most of us need!

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