|Report Code: PP10123||Published: May 2019||Pages: 98||Available format:|
|Therapeutic Area(s):||Ophthalmology||Report Type: Indication Pipeline Reports|
Graves’ ophthalmopathy (also called Graves’ orbitopathy; thyroid eye disease (TED); dysthyroid/thyroid-associated orbitopathy (TAO)) is an autoimmune disorder wherein ocular and orbital tissues are affected by the overproduction of thyroid hormones. It is considered to be the most common extrathyroidal manifestation of Graves’ disease (GD) and leads to the expansion of extraocular muscles and fat in the eye orbit.
Some of the signs and symptoms associated with this disease include inflammation or redness in conjunctiva, dry eyes, swollen eyelids, increased sensitivity, bulging or forward displacement of the eyes (proptosis), and double vision. The disease can be diagnosed with an eye examination, and through computed tomography, and magnetic resonance imaging (MRI) scans. However, lack of awareness amongst patients about this disease and unavailability of a routine screening have become unmet needs in this therapeutic area.
As per the current scenario, drug developers are actively collaborating and partnering with other companies to expand their pipeline portfolio for the treatment of this disease. For instance, in December 2017, Roivant Sciences GmbH and HanAll Biopharma Co. Ltd. signed a collaboration and licensing agreement under which Roivant Sciences GmbH gained exclusive license to develop, manufacture, and commercialize RVT-1401 (formerly HL161) in the U.S., Canada, Mexico, European Union (EU), the U.K., Switzerland, the Middle East, and North Africa.
Similarly, Horizon Pharma plc, a key player in the Graves’ ophthalmopathy pipeline acquired River Vision Development Corp. to expand its pipeline portfolio. The company gained acquisition rights for teprotumumab from this transaction, which is currently undergoing Phase III clinical studies. Teprotumumab is observed to be a potential drug candidate for the treatment of this disease and has been granted Orphan, Fast-track, and Breakthrough Therapy designation by the United States Food and Drug Administration (USFDA). Furthermore, Horizon Pharma plc is planning to file biologics license application (BLA) for teprotumumab, and the drug is anticipated to hit the market by year 2020.
Key Pipeline Drivers
Positive clinical trial results and strategic decisions of the players to collaborate with other companies are facilitating the growth of the pipeline. For instance, Horizon Pharma plc announced results of teprotumumab, from the Phase III confirmatory clinical trial (OPTIC). According to these results, teprotumumab showed significant reduction in the complications of the disease. In addition, the designations granted by the regulatory bodies and institutes, including the USFDA, the European Medicines Agency (EMA), and the National Institutes of Health (NIH) help in achieving different development milestones for the pipeline drug candidates.
However, unavailability of targeted therapy is a key factor hindering the growth of the pipeline, as there is no marketed product indicated for this disease yet. Further, lack of an early diagnosis due to unavailability of advanced diagnostic tools and unawareness amongst patients, and need for a defined treatment algorithm are other challenges faced by the healthcare providers, as a lot of questions arise in the minds of researchers and healthcare providers while prescribing preventative medicines to the patients.
The Graves’ ophthalmopathy pipeline currently comprises of 8 therapeutic candidates in different stages of development.
Horizon Pharma plc, Roivant Sciences GmbH, Enceladus Pharmaceuticals BV, and Apitope International NV are the players involved in the development of Graves’ ophthalmopathy therapeutics.
Some highlights of the report “Graves’ Ophthalmopathy Therapeutics – Pipeline Analysis 2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments” have been mentioned below: