Shares of Sun Pharmaceuticals have climbed more than 3 percent this morning after the U.S. Food and Drug Administration approved its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09 percent.
Shares of Sun Pharmaceuticals have climbed more than 3 percent this morning after the U.S. Food and Drug Administration (FDA) approved its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09 percent.
When Cequa hits the market, it will be commercialized in the United States by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma’s wholly owned subsidiary. Cequa is dosed twice daily and will be available as a single-use vial.
Dry eye disease (keratoconjunctivitis sicca) affects approximately 16 million people in the United States. According to the National Eye Institute, dry eye disease occurs when tears manufactured by the body aren’t significant to keep the eye lubricated. When that happens, people experience a scratchy and itchy sensation. The risk of developing dry eye increases with advancing age and is more common in women than in men. Cequa was developed to increase tear production in patients with dry eye.
Abhay Gandhi, chief executive officer of Sun Pharma North America, said dry eye disease is an area of high unmet need, with a “significant number of patients who are currently untreated.” Gandhi said the FDA approval of Cequa is an important milestone in the development of Sun’s ophthalmic’s business.
Sun Pharma hopes Cequa can wrest away a significant portion of the dry eye disease market from popular treatments such as Allergan’s blockbuster treatment Restasis or Shire’s Xiidra, which was approved in 2016. Other companies are also taking aim at the dry eye market, including Mylan and Kala Pharmaceuticals. The increase in competition has been carefully timed as Restasis begins to lose patent protection. The U.S. dry eye disease market is projected to hit $7.7 billion by 2025, according to a January prediction by Transparency Market Research.
Cequa’s nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules, the company said. The small size of the nanomicelles eases entry into corneal and conjunctival cells, which enables the delivery of high concentrations of cyclosporine A (CsA). Cequa, Sun said, provides the highest FDA-approved concentration of CsA and is the only CsA-approved product that uses nanomicellar technology. The FDA approval was based on Phase III data that showed after 12 weeks of treatment, Cequa showed statistically significant improvement in the eye in comparison to the vehicle.
Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of Cequa is welcomed news, and I look forward to offering my patients this compelling new option,” Jodie Lucks, the principal investigator of the Phase III trial said in a statement.
