NDA Submitted for MydCombi, a Novel Mydriatic Agent
The NDA submission is supported by data from the phase 3 MIST-1 and MIST-2 studies.
Miscellaneous Ocular Agents
Tepezza Supply Shortage Expected Soon
As both the vaccine and Tepezza are being manufactured at Catalent, the government has prioritized the manufacturing of the vaccine thereby resulting in cancellation of previously contracted Tepezza orders.
Cystadrops Now Available for Patients With Cystinosis
The Food and Drug Administration approved Cystadrops in August 2020.
Levodopa Benefits Neovascular Age-Related Macular Degeneration
Levodopa is safe and well-tolerated, improves visual outcomes, and delays anti-VEGF treatment.
Cystadrops Approved to Treat Corneal Crystal Deposits in Cystinosis
Cystinosis is a rare, multisystem genetic disorder caused by an accumulation of cystine crystals throughout the body, including the eyes.
FDA Warns of Risks Associated With Intraocular Use of Moxifloxacin
According to the Agency, 29 reports of TASS were identified following a search of the FDA Adverse Event Reporting System database through December 19, 2019.
Upneeq Approved for Acquired Blepharoptosis
The FDA has approved Upneeq™ (oxymetazoline hydrochloride ophthalmic solution; Osmotica) for the treatment of acquired blepharoptosis in adults.
Ear Precipitate Formation Following Otitis Externa Treatment
Upon examination, the patient’s external ear canal was found to be inflamed, red, and swollen, and she was subsequently diagnosed with otitis externa.
Beovu Labeling Updated With Additional Safety Information
The Food and Drug Administration (FDA) has approved updated labeling for Beovu® (brolucizumab; Novartis) to include additional safety information regarding the risk of retinal vasculitis and retinal vascular occlusion. Beovu received FDA approval in October 2019 for the treatment of wet age-related macular degeneration (wet AMD). The Warnings and Precautions section has been updated with…
Low Doses of Bevacizumab Tested for Retinopathy of Prematurity
Phase 1 study suggests that intravitreous injection of 0.004mg may be lowest effective dose.
