FDA approves generic version of cyclosporine ophthalmic emulsion as treatment for dry eye

The FDA has approved the first generic Cyclosporine Ophthalmic Emulsion (Restasis; Allergan, an AbbVie company) 0.05% single-use eye drops vials to increase tear production in patients with dry eye disease.

According to a press release, tear production has not been observed in patients currently taking topical anti-inflammatories or using punctal plugs.

The generic version is sponsored by Mylan Pharmaceuticals. The company is part of Viatris. There are no legal or regulatory hurdles left, and the company said in a statement it was launching immediately.

Sally Choe, PhD, director of the Office of Generic Drugs at the FDA’s Center for Drug Evaluation and Research, pointed out in the press release that restasis has been approved for use in the United States for nearly 20 years, but until today, there was no generic product approval of this drug.

“Today’s approval reflects the FDA’s continued commitment to advancing patient access to high-quality, lower-cost generic medicines that are as safe and effective as their brand name counterparts,” said she said in a statement. “Supporting the development and expanding market opportunities for complex generic medicines is a key focus of our efforts to help improve competition and reduce drug prices.”

Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is suspected to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, also known as dry eye. Dry eye is a common condition that occurs when a patient’s tears are unable to provide adequate lubrication to their eyes. Tears can be inadequate and unstable for many reasons, but instability can lead to discomfort, inflammation, and potential damage to the surface of the eye.

The most frequently reported adverse reaction in clinical trials with cyclosporine ophthalmic emulsion was burning eyes. Other reactions included conjunctival hyperaemia (dilation and redness of blood vessels in the eye), discharge, epiphora (excessive tearing of the eye), eye pain, foreign body sensation (the feeling of having something in the eye), pruritus (itchy skin), tingling and visual disturbances (most often blurred).

“I am thrilled that Viatris has received the first FDA approval for generic Restasis after working for nearly a decade to not only develop a more affordable product, but also to remove all barriers to entry and enable the patient access,” Viatris Chairman Rajiv Malik said in a statement. “We are also proud to add another first to our growing list of industry-defining scientific achievements by bringing complex and difficult-to-manufacture products to market.”

Viatris Developed Markets President Tony Mauro said the Restasis generic approval reinforces “the company’s continued commitment to providing innovative solutions and increasing access to more affordable treatment options for patients.” .

“We look forward to quickly bringing this important product to millions of Americans with chronic dry eye disease,” he said in a statement.

According to the FDA, applicants must submit appropriate data and information to demonstrate that generic drugs meet the FDA’s rigorous approval standards, ensuring that generic drugs are safe, effective, and meet the same high-quality standards as their brand counterparts.

The development of complex generics can be more difficult due, for example, to the complexity of their formulation of active ingredients or their route of administration. As a result, many complex drugs have no generic competition. The FDA has taken a multifaceted approach to encouraging the development of complex generics through the Generic Drug User Fee Amendments (GDUFA) program.


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