Restasis MDPF (multi-dose preservative free ciclosporin ophthalmic formulation) / AbbVie - LARVOL DELTA

Annual anti-inflammatory review (Healio) - "After the 'year of steroids' in 2019, this year turned out to involve little of note when it comes to steroids. Like me, you probably noticed that increased IOP is still an issue with long-term steroid use regardless of which one you use. Poor Kala has yet to get its version of loteprednol for intermittent dry eye symptomatic flare-ups approved by the FDA. Its PDUFA date is sometime in October; soon after you read this, we will learn if there will be a topical steroid drop with the words 'dry eye' in its labeling. We should be cheering for Eysuvis to be approved if just to hear Mitch Jackson rail at an insurance company for changing his prescription to a non-FDA-approved alternative. Prediction: We use steroids more frequently for shorter periods of time in 2021. Corollary: We attempt a return to the cyclosporine/lifitegrast combo for chronic dual treatment at the expense of chronic steroid use."

Online posting

Allergan receives complete response letter from FDA for prior approval supplement for RESTASIS (cyclosporine ophthalmic emulsion) 0.05% multi-dose preservative-free bottle (Allergan Press Release) - "Allergan...announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its Prior Approval Supplement (PAS) for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, Multi-Dose Preservative-Free (MDPF) presentation."

FDA event • Dry Eye Disease • Ophthalmology

Allergan's Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05% approved in Canada (Canada Newswire) - "Allergan plc announced today that it has received approval from Health Canada for RESTASIS MULTIDOSE...multi-dose bottle offering the same preservative-free formulation of RESTASIS, in a new, easy-to-use multi-dose bottle."

Canadian regulatory • Dry Eye Disease • Ophthalmology

Allergan introduces Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05%, a new delivery system for the one and only FDA approved treatment to help patients produce more of their own tears (Allergan Press Release) - "Allergan...announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for RESTASIS MULTIDOSE...a preservative-free, multi-dose bottle offering the same preservative-free formulation of RESTASIS since the launch in 2003."

NDA • Dry Eye Disease • Ophthalmology

Allergan announces availability of Restasis multidose (cyclosporine ophthalmic emulsion) 0.05% -- the first FDA-approved preservative free prescription eye drop available in a multidose bottle (Allergan Press Release) - "Allergan...announced the availability of RESTASIS MULTIDOSE™, which is the same preservative-free RESTASIS® formulation, but now offered in a multidose bottle...RESTASIS MULTIDOSE...is the first and only FDA-approved preservative-free, prescription eye drop in the U.S. to be available in a multidose bottle."

Launch US • Dry Eye Disease • Ophthalmology

Restasis MDPF: Anticipated patent protection until 2032 (Allergan) - Q4 FY 2016 Results

Anticipated patent expiry • Dry Eye Disease • Ophthalmology

It takes a village to care for dry eye patients (Ophthalmology Times) - "I work with many optometrists in the surrounding community who will diagnose patients with dry eye and offer a range of treatments to address their symptoms. They may prescribe immunomodulators like Restasis (Allegan), Xiidra (Novartis), or Cequa (Sun), microwavable moisture masks, oral omega-3 supplements, lid hygiene wipes, and artificial tears."

Online posting