Sun Pharmaceutical Industries Ltd Announces U.S. FDA Approval of CEQUA to Treat Dry Eye
Deepthi | Myequity news | Date : 16-08-2018 15:30:00 IST
Sun Pharmaceutical Industries Ltd. today announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA. CEQUA is dosed twice daily and will be available as a single-use vial.
“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of CEQUA represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. CEQUA, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”
Additionally, Jodi Luchs, MD, the principal investigator behind the CEQUA confirmatory Phase 3 trial, noted: “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.”About Sun Pharmaceutical Industries Ltd:
Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States. The company offers formulations in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology and diabetology. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as well as anticancers, steroids, peptides, sex hormones, and controlled substances.
The 2014 acquisition of Ranbaxy has made the company the largest pharma company in India, the largest Indian pharma company in the US, and the 5th largest specialty generic company globally. Over 72% of Sun Pharma sales are from markets outside India, primarily in the US. The US is the single largest market, accounting for about 50% turnover; in all, formulations or finished dosage forms, account for 93% of the turnover. Manufacturing is across 26 locations, including plants in the US, Canada, Brazil, Mexico and Israel. In the US, the company markets a large basket of generics, with a strong pipeline awaiting approval from the U.S. Food and Drug Administration (FDA).