Ophthalmology

Izervay, which is expected to be available within the two to four weeks, will have a list price of $2,100 per vial.

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.

Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.

Vevye (previously CyclASol) is a water-free, preservative-free solution, which allows for improved bioavailability and better efficacy on the target tissue.

Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.

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.

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

Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.

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.

Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.

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.

If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.

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.

If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.

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.

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.

The FDA has assigned a target action date of Feb. 11, 2023.

Omlonti is approved to reduce elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension

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’s CyclASol uses a new technology that allows cyclosporine to be soluble without water or preservatives.

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.

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.

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.

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

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.

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.

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

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.

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

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