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.