September 27th 2023
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
September 26th 2023
Iyuzeh can be stored at room temperature. It has a list price of $299 for a month’s supply.
September 12th 2023
Miebo, approved in May, addresses tear evaporation in dry eye disease. It will have a wholesale acquisition cost of $771 for a one-month supply.
August 30th 2023
The anti-cancer drug bevacizumab is used off-label to treat wet AMD. Outlook Therapeutics had developed an ophthalmic formulation of bevacizumab for intravitreal injection.
August 21st 2023
The higher dose of Eylea allows longer intervals between injections for patients with macular degeneration and diabetic retinopathy. It will have a list price of $2,625 per single-use vial.
FDA Approves Izervay to Treat Geographic Atrophy
Izervay, which is expected to be available within the two to four weeks, will have a list price of $2,100 per vial.
FDA Rejects Higher Dose of Eylea
At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.
FDA Issues CRL for Treatment for Rare Retinal Cancer
Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.
FDA Approves Novel Cyclosporine for Dry Eye Disease
Vevye (previously CyclASol) is a water-free, preservative-free solution, which allows for improved bioavailability and better efficacy on the target tissue.
CMS Grants Pass-through Reimbursement for Iheezo
Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.
FDA Accepts for Priority Review Drug for Rare Retinal Cancer
If approved, ADX-2191 could be the first marketed drug specifically for patients with primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023.
FDA Sets Goal Date for Blurry Vision Therapy
CSF-1 is a low-dose pilocarpine to treat patients with age-related blurry vision. The FDA has assigned a PDUFA goal date of Oct. 22, 2023
FDA Approves First Drug for Geographic Atrophy Due to AMD
Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.
FDA Grants Priority Review to AMD Therapy
Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.
FDA Approves First Pediatric Indication for Blockbuster Eylea
Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.
FDA Sets PDUFA Date for Dry Eye Disease Drug
If approved, reproxalap would be the first inhibitor of RASP to treat patients with dry eye disease. The FDA PDUFA date is Nov. 23, 2023.
Orasis Submits NDA for Blurry Vision Treatment
If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.
FDA Approves Iyuzeh to Reduce Intraocular Pressure
Iyuzeh is a preservative-free formulation of latanoprost and doesn’t need to be stored at refrigerated temperatures. It will be available in the second half of 2023.
Aldeyra Submits NDA for the Novel Dry Eye Therapy Reproxalap
If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.
FDA Updates Target Date for Pegcetacoplan
Appellis had submitted updated data for the pegcetacoplan in age-related macular degeneration, which is considered a major amendment to the NDA. The new PDUFA date is Feb. 26, 2023.
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
The FDA has assigned a target action date of Feb. 11, 2023.
FDA Approves Omlonti for Glaucoma
Omlonti is approved to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension
FDA Accepts NDA for Novel Dry Eye Disease Therapy
If approved, NOV03 would be the first prescription eye drop to address excessive tear evaporation. The FDA has assigned a PDUFA action date of June 28, 2023.
Novaliq Submits NDA for Dry Eye Treatment
Novaliq’s CyclASol uses a new technology that allows cyclosporine to be soluble without water or preservatives.
FDA Approves First Interchangeable Biosimilar to Lucentis
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 Accepts NDA for Pegcetacoplan for Advanced Macular Degeneration
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.
Bausch + Lomb Submits NDA For Dry Eye Disease Therapy
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.
FDA Accepts sBLA for Eylea in Diabetic Retinopathy
Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.
CMS Issues J-Code for Xipere to Treat Macular Edema
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.
Biogen/Samsung Bioepis Launch the Biosimilar Byooviz
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.
Therapy for Blurry Vision Shows Positive Results
Phase 3 trials show CSF-1, a low-dose pilocarpine, met clinical endpoints for improving presbyopia, or age-related blurry vision.
Bausch + Lomb Launches Xipere for Macular Edema
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.
AllianceRx Walgreens Prime Continues as Exclusive Pharmacy for Cystaran
Cystaran is a topical ophthalmic therapy that is used to treat a rare genetic disorder.
UnitedHealthcare Adds Eysuvis, Cigna Makes it Preferred Brand
This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.
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