Clinical

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


Aldeyra Submits NDA for the Novel Dry Eye Therapy Reproxalap 


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 Updates Target Date for Pegcetacoplan

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 NDA for Novaliq’s New Dry Eye Therapy

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

FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants

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

FDA Approves Omlonti for Glaucoma

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

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.

FDA Accepts NDA for Novel Dry Eye Disease Therapy

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

Novaliq Submits NDA for Dry Eye Treatment

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.

Ophthalmology