One of Sun Pharmaceutical Industries' wholly-owned subsidiaries has commercialised CEQUA (cyclosporine ophthalmic solution) 0.09% in the United States, it was reported yesterday.
The United States Food and Drug Administration (FDA) has approved CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use and is indicated to increase tear production in patients with keratoconjunctivitis sicca. It is claimed to be the first and only FDA-approved cyclosporine treatment delivered with nanomicellar technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration.
Paul Karpecki, OD, FAAO, director of cornea services at the Kentucky Eye Institute in Lexington, said, 'Keratoconjunctivitis sicca causes symptoms of burning, stinging, itching, grittiness, and dryness, underscoring the need for tolerable drug therapy with a fast onset of action. The CEQUA clinical study results strengthen the rationale for using this product as a means to penetrate the tear film and improve drug delivery of cyclosporine into the eye.'
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval