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%.
Restasis, a calcineurin inhibitor immunosuppressant, is indicated to increase tear production.
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.
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.
Pain sensitivity and pain tolerance are associated with symptoms of dry eye disease (DED).
For pediatric patients undergoing hematopoietic stem cell transplantation (HSCT), complications are common, but are generally mild and self-limiting.
The American Academy of Ophthalmology (AAO) is participating in the Choosing Wisely campaign and has identified five tests and treatments that may be overused.
SARcode Bioscience announced topline results from OPUS-1, a pivotal Phase 3 study of lifitegrast ophthalmic solution, 5%, vs. placebo for the treatment of dry eye disease.
Fera announced that Puralube (white petrolatum and mineral oil), a preservative free ophthalmic ointment, is available again to relieve the symptoms of dry eye.
RegeneRx Biopharmaceuticals announced that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease.
Alcon announced that it has expanded its Systane product line with the launch of Systane Balance lubricant eye drops for evaporative dry eye in patients with Meibomian Gland Dysfunction (MGD).
ISTA Pharmaceuticals announced the results from its Phase 2 trial of Remura (bromfenac ophthalmic solution) for the treatment of dry eye disease.