The NDA includes data from one Phase 2 and two Phase 3 clinical trials (STRIDE 1 and STRIDE 2) involving ~2000 individuals with dry eye disease.
The new ocular drops contain carboxymethylcellulose (CMC) 0.5%, hyaluronic acid (HA), glycerin 0.9%, and other organic osmoprotectants.
The micro-emulsion contains povidone 0.68% and propylene glycol 0.3%, which work by mimicking a natural tear to restore moisture to the tear film for up to 12 hours.
Safety and efficacy of the TrueTear device were demonstrated in two clinical studies in a total of 145 individuals with aqueous deficient dry eye.
Restasis, a calcineurin inhibitor immunosuppressant, helps increase the eyes' natural ability to produce tears in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Compared with the placebo group, the ω-3 EFA group had a greater reduction in Ocular Surface Disease Index score and tear osmolarity at day 90 versus baseline.
Sun Pharma announced successful Phase 3 results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a preservative-free, aqueous solution with a proprietary nanomicellar formulation of cyclosporine A 0.09%.
Nine out of 10 laser in situ keratomileusis (LASIK) patients report satisfaction afterwards, although a sizable percentage experience new visual disturbances up to six months after the procedure, according to research published online in JAMA Ophthalmology.
Allergan announced the submission of a de novo application to the Food and Drug Administration (FDA) for the Oculeve Intranasal Tear Neurostimulator device.
Shire announced that the Food and Drug Administration (FDA) has approved Xiidra (lifitegrast ophthalmic solution) 5% for the treatment of the signs and symptoms of dry eye disease in adults. This is the first prescription ophthalmic solution approved to treat both signs and symptoms of this condition.
Vitamin D deficiency is associated with dry eye and impaired tear function, according to a study published in the January issue of the International Journal of Rheumatic Diseases.
Shire announced positive topline results from OPUS-3, a Phase 3 efficacy and safety study of lifitegrast for the treatment of signs and symptoms for dry eye disease.
Allergan announced the launch of Refresh Optive Gel Drops, a new aqueous gel indicated for patients who require or desire a more viscous artificial tear option to relieve dry eye symptoms.
The FDA has issued a complete response letter (CRL) requesting an additional clinical study for the New Drug Application (NDA) of lifitegrast (Shire) for the signs and symptoms of dry eye disease in adults.
As dry eyes is one of the most common reasons for patient visits to eye care professionals, the latest issue of the journal Optometry and Vision Science focuses on progress in the risk factors, diagnosis, and treatment of dry eye disease.
Allergan plc. announced a voluntary recall of specific lots of REFRESH Lacri-Lube, REFRESH PM, FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment USP) 10%/0.2% due to the presence of particular matter.
The FDA has accepted for filing and granted Priority Review designation to the New Drug Application (NDA) for lifitegrast (Shire) for the treatment of signs and symptoms of dry eye disease in adults.
Shire has submitted a New Drug Application (NDA) to the FDA for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.
Shire announced results from its Phase 3 OPUS-2 study and Phase 3 SONATA safety study investigating lifitegrast (5.0% ophthalmic solution) in adults with dry eye disease.
Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products due to concerns of lack of sterility assurance.
Shire announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution for dry eyes.
Altaire is voluntarily recalling nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, an OTC product used to relieve dry eyes.