Ophthalmology

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.

Vuity, developed by Allergan, is a once-daily eye drop to treat presbyopia.

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

Genentech’s Susvimo is a refillable implant that delivers medication continuously for up to six months.

Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

Three commercial plans now cover the corticosteroid Eysuvis.

FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

New molecular entity: FDA approved tafluprost 0.0015% (Zioptan, Merck) ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)