Clinical

Articles

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. 

FDA Sets PDUFA Date for Dry Eye Disease Drug

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

Orasis Submits NDA for Blurry Vision Treatment

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.

FDA Approves Iyuzeh to Reduce Intraocular Pressure

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.

Ophthalmology