The Federal Drugs Agency (FDA) has approved the Abbreviated New Drug Application for the making of Cyclo-sporine Ophthalmic Emulsion 0.05%, the first generic version of AbbVie Inc's Re-stasis. (1)

Re-stasis was acquired by Illinois-based AbbVie in 2020 when the company completed the US$63 billion acquisition of the California-based Allergan Inc. (2)

FDA’s permit for the manufacture of the generic version of Re-stasis was given to Mylan Pharmaceuticals Inc, a subsidiary of Viatris Inc, with the company saying in February 2022 it was launching the drug in the market “immediately.” (ibid)

FDA’s decision to approve the generic version of Allergan’s Re-stasis comes nearly three years after the US health regulator’s Dermatologic and ophthalmic Drugs Advisory Committee rejected a request to recommend the drug (cyclo-sporine ophthalmic emulsion 0.05%) for the treatment of keratoconjunctivitis sicca or dry eye disease that presents as a chronic, bilateral desiccation of the conjunctiva and cornea due to too little tear production or accelerated tear evaporation.

With the approval of the manufacture of the generic version of Re-stasis, Viatris Inc says the global campaign to deliver innovative solutions and access to treatment of dry eye syndrome has been reinforced now that “more affordable treatment options for patients” are available. (3)

Viatris Inc, which was formed in November 2020 through a merger of generic drugmaker Mylan Pharmaceuticals and Pfizer Inc's  off-patent drug business, said it has taken more than a decade for the generic variety of Re-stasis to be developed and has now raised the hopes of patients with the dry dye disease of finally accessing “a more affordable product.” (ibid)

The Cyclo-sporine Ophthalmic Emulsion boosts tear production in patients who have their tear generation suppressed because of ocular inflammation that is associated with dry eye disease.

Previously, FDA had also approved Eysuvis (lote-prednol eta-bonate ophthalmic suspension) 0.25% that is manufactured by Kala Pharmaceuticals, a biopharmaceutical firm specializing in the discovery, development and commercialization of innovative therapies for eye diseases. (4)

Moreover, FDA has also in the recent past approved Synfo, which is manufactured by international ophthalmic company SIFI. The drug is a synergistic blend of two polymers, sodium hyaluronate and xanthan gum, and two osmoprotectants, betaine and glycine and was first launched in the market in January 2021. (5)

Synfo moisturizes and lubricates the eye in addition to compensating tear instability, restore tears’ volume and ocular surface’s health, as well as provide antioxidant and osmoprotective properties according to SIFI.

More like Eysuvis and synfo, the generic version of Re-stasis, which has cyclo-sporine as the active ingredient, has potential to increase tear production among people with the ocular surface disease.

In 2021, Re-stasis generated revenue of $1.29 billion for AbbVie in 2021, a 64% jump from a year earlier according to the company’s unaudited key products’ revenues for the 12 months ending 31 December 2021. (6)

Dry eye disease has universally been linked to factors such as age, gender, medications, medical conditions, such as such as diabetes, thyroid disorders, Sjogren’s syndrome, lupus, scleroderma, rheumatoid arthritis and environmental conditions.

Furthermore, due to the increasing incidences of dry eye disease, the pharmaceutical industry and healthcare distribution companies are adding up to the list of medical drug solutions with other reports indicating that in 2021, the dry eye disease market products such as liquid drops, gel, liquid wipes and eye ointment surpassed US$ 4.2 billion. (7)

With dry eye disease inducing factors such as diabetes and aging expected to increase, demand for dry eye medical drugs would continue growing in the short to medium.

For example the number of people aged 65 and older is expected to increase from 524 million in 2010 to 1.5 billion in 2050 (8) while the global population of adults living with diabetes is projected to rise from 537 million in 2021 to 643 million by 2030 and 7832 million by 2045. (8)

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References;

1. https://newsroom.viatris.com/2022-02-03-Viatris-is-First-to-Receive-FDA-Approval-of-Generic-Re-stasis-R-Cyclo-sporine-Ophthalmic-Emulsion-0-05-to-Treat-Dry-Eye-Disease

2. https://news.abbvie.com/news/press-releases/news-type/corporate-news/abbvie-inc-completes-acquisition-allergan-plc.htm

3. https://newsroom.viatris.com/2022-02-03-Viatris-is-First-to-Receive-FDA-Approval-of-Generic-Re-stasis-R-Cyclo-sporine-Ophthalmic-Emulsion-0-05-to-Treat-Dry-Eye-Disease

4. https://investors.kalarx.com/news-releases/news-release-details/kala-pharmaceuticals-announces-fda-approval-eysuvistm-short-term

5. https://www.sifigroup.com/dettnews-SIFI_LAUNCHES_SYNFO,_A_NEW_TREATMENT_FOR_DRY_EYE_DISEASE/551_27/en/

6. https://investors.abbvie.com/static-files/4805c635-ab17-4c3f-94dd-dc9bf18fbf8c

7. https://www.imarcgroup.com/dry-eye-syndrome-market

8. https://www.who.int/ageing/publications/global_health.pdf

9. https://diabetesatlas.org/

About the Author:

With great honor and pleasure, PharmaSources.com has now invited Shem Oirere as one of the original writers. He graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.