iDose TR was approved to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It has a wholesale acquisition cost of $13,950 per dose/implant.
Outlook Therapeutics plans to begin a study in the first quarter of 2024 to address the issues identified in a FDA complete response letter. If approved, Lytenava would be the only bevacizumab product to specifically treat age-related macular degeneration.
Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.