Clinical

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Articles

Coherus’ Cimerli has been approved to be interchangeable for all five indications, including age-related macular degeneration and diabetic retinopathy. It will be available in early October 2022.

FDA Approves First Interchangeable Biosimilar to Lucentis

Pegcetacoplan is a targeted therapy to treat patients with age-related macular degeneration. The Prescription Drug User Fee Act (PDUFA) target action date is Nov. 26, 2022. 

FDA Accepts NDA for Pegcetacoplan for Advanced Macular Degeneration

NOV03 (perfluorohexyloctane) is a first-in-class eye drop with a novel mechanism of action. If approved it will be the first to address signs and symptoms of dry eye disease.

Bausch + Lomb Submits NDA For Dry Eye Disease Therapy

Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.



FDA Accepts sBLA for Eylea in Diabetic Retinopathy

Xipere became commercially available in March 2022. It is the first therapy for patients with macular edema that provides a targeted delivery to the retina.

CMS Issues J-Code for Xipere to Treat Macular Edema

Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.

Biogen/Samsung Bioepis Launch the Biosimilar Byooviz

Phase 3 trials show CSF-1, a low-dose pilocarpine, met clinical endpoints for improving presbyopia, or age-related blurry vision.

Therapy for Blurry Vision Shows Positive Results

Xipere is a targeted treatment that is delivered via an injection to the back of the eye to treat macular edema associated with uveitis, a form of eye inflammation.


Bausch + Lomb Launches Xipere for Macular Edema

Cystaran is a topical ophthalmic therapy that is used to treat a rare genetic disorder.

AllianceRx Walgreens Prime Continues as Exclusive Pharmacy for Cystaran

This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.


Ophthalmology