David Hutton

The company announced a PDUFA goal date of Aug. 19, 2023. The FDA has not identified any potential review issues and is not currently planning to hold an Advisory Committee meeting for avacincaptad pegol.

Three of Frontera’s gene therapy product candidates have entered clinical trials since the beginning of the year.

According to a news release, Akari is targeting an Investigational New Drug application submission to the FDA in the first half of 2024.

The collaboration may provide insights to help improve the treatment paradigm for retinal disorders.

According to the company, the formulations do not contain preservatives or boric acid and have a physiologic pH of 5.5. They also can be stored at room temperature for up to 180 days.

Saunders will return to Bausch + Lomb after having served at the company as CEO from 2010 to 2013.

According to the companies, the collaboration will combine Formosa's APNT nanoparticle formulation platform with Eyenovia's Optejet dispensing technology for the development of new ophthalmic therapies in indications with significant unmet medical needs.

A recent clinical study demonstrates that low intracranial pressure correlates with impaired patient visibility, especially in the nasal zone.

If approved later this year, phentolamine ophthalmic solution 0.75% could be the only commercially available eye drop for the reversal of dilation. It is being developed for reversal of pharmacologically-induced mydriasis, presbyopia, and dim light vision disturbances under the 505(b)(2) pathway.

The findings from a National Institutes of Health-supported clinical trial may help guide the management of diabetic eye disease.

The company noted that all OTX-TKI treated subjects who were rescue-free at the Month 7 interim analysis remained rescue-free, extending the 73% rescue-free rate up to Month 10.

Rishi Singh, MD, presented data from the Phase 3 DERBY and OAKS clinical trials for geographic atrophy at the 2023 Angiogenesis, Exudation, and Degeneration conference.

In a presentation at the Angiogenesis, Exudation, and Degeneration 2023 conference, Justis Ehlers, MD, presented "Ellipsoid Zone Integrity in Dry AMD: An Imaging Biomarker for Progression Risk and Clinical Trial Endpoint.”

Roche announced that faricimab met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared to aflibercept.

According to Regeneron, aflibercept injection is now approved to treat five retinal conditions caused by ocular angiogenesis.

According to Lento Bio, its collaboration with FSU will focus on medicinal chemistry and will help accelerate lead asset development, with board expansion focused on well-rounded scientific expertise.

According to investigators, the new discovery enhances our understanding of the previously unknown function of genomic regions outside the genes.

According to the company, EA-2353 takes a novel, small-molecule approach and selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve or restore visual function.

A POSTECH research team has developed a wireless theranostic smart contact lens for monitoring and control of intraocular pressure in glaucoma.

L. Jay Katz, MD, provides some key takeaways from his Glaucoma 360 2023 presentation, "Steroid Induced Glaucoma Management."

Ying Han, MD, PhD, provides some key takeaways from her Glaucoma 360 2023 presentation, "Tube shunt update."

The Phase 2 SPECTRA clinical trial will assess 4D-150 in patients with DME.

According to the indictment, beginning in June 2017, Anthony David Flores and Anna Rene Moore used false promises and representations to befriend the victim — an ophthalmologist and successful investor worth more than $60 million.

The results are consistent with those observed, and previously published by the same group, showing benefit in age related macular degeneration models and highlights the potential value of ophNdi1 for multiple eye diseases.

The company noted that the product is a sterile, single-patient use, physician administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.

The vision care company is joining forces with the global nonprofit to fight avoidable blindness around the world.

According to the company, ONL1204 is a first-in-class small molecule Fas inhibitor with a mechanism of action designed to provide neuroprotection for retinal cells.

In a news release, the CDC is urging that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete.

According to the company, the approval allows Eyenuk’s EyeArt AI eye screening system, already approved for detection of diabetic retinopathy, to aid millions of additional patients at risk for vision loss.

With donations, the West Virginia University Department of Ophthalmology and Visual Sciences has added two new pieces of ophthalmic training equipment to its lab.