SPOTLIGHT -
Agents in late-stage development for the treatment of eye diseases.
FDA Issues Complete Response for Novel Dry Eye Therapy
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.
FDA Approves Byooviz as Interchangeable Lucentis Biosimilar
Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.
FDA Approves Drop for Drug-Induced Dilation of the Pupils
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
Preservative-free Therapy Launches to Reduce Intraocular Pressure in Glaucoma
Iyuzeh can be stored at room temperature. It has a list price of $299 for a month’s supply.
Bausch + Lomb Launches Miebo for Dry Eye Disease
Miebo, approved in May, addresses tear evaporation in dry eye disease. It will have a wholesale acquisition cost of $771 for a one-month supply.
FDA Issues CRL for Bevacizumab to Treat Wet AMD
The anti-cancer drug bevacizumab is used off-label to treat wet AMD. Outlook Therapeutics had developed an ophthalmic formulation of bevacizumab for intravitreal injection.
