FDA review extended for dry eye disease treatment

The FDA extended the PDUFA target action date for the New Drug Application for reproxalap by Aldeyra Therapeutics. The new PDUFA date is March 16. The original PDUFA date was December 16, but after a December 12 meeting, the FDA requested the company include its Clinical Study Report for the dry eye disease field trial of reproxalap. The company has submitted this report at the FDA’s request.

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Key data gathered for expected NDA submission

Nicox announced that it has completed its gathering and analysis of data required for its upcoming NDA submission of NCX 470 for treatment of glaucoma and ocular hypertension. According to the company’s press release, the NDA submission is expected in the U.S. in the first half of 2026, followed by a submission in China.

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Phase 2b results for GA treatment

Aviceda Therapeutics announced topline results from its Phase 2b study evaluating AVD-104 in patients with geographic atrophy (GA). There was no statistical difference in rate of GA area change between AVD-104 and monthly avacincaptad pegol, which served as the control. The company’s press release noted that “imbalances in key baseline lesion characteristics across treatment arms contributed to the lesion-growth outcomes.” The study also found that the AVD-104 treatment resulted in clinically meaningful reductions in GA lesion growth rate. The company plans to advance AVD-104 with two Phase 3 confirmatory studies, which it expects to begin in 2026.

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Phase 3 studies discontinued for thyroid eye disease

argenx SE announced that it was discontinuing its Phase 3 studies evaluating efgartigimod subcutaneous (efgartigimod alfa and hyaluronidase-qvfc) for treatment of moderate to severe thyroid eye disease. The company stated in a press release that the discontinuation of these studies is based on the recommendation from an Independent Data Monitoring Committee based on pre-specificized interim analysis.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13, 2026. Get involved with the meeting by submitting a case video—learn more.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.

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Research highlights

• The outcomes of a hydrophobic trifocal IOL (FineVision HP IOL, Beaver-Visitec) in eyes with differing axial lengths (AL) were evaluated in a prospective study. The study included 116 eyes that all received the FineVision HP IOL. Group A (n=17) included eyes with an AL of 21.00–22.50 mm, group B (n=83) had an AL of more than 22.50–24.00 mm, and Group C (n=16) had an AL of more than 24.00–28.50 mm. At postop month 3, the investigators obtained manifest refraction, monocular logMAR UDVA, corrected CDVA, UNVA, and DCNVA. Overall, the investigators found that this IOL provided good visual and refractive outcomes at all axial lengths. This study was published in the journal Clinical Ophthalmology.
• A meta-analysis published in the Journal of Cataract & Refractive Surgery compared transepithelial PRK (transPRK) with classic (mechanical or alcohol-assisted) PRK. Studies that compared transPRK and PRK efficacy, safety, predictability, correction index, difference vector, or index of success were included (20 studies with 10,204 eyes). The study found no statistically significant difference in visual outcomes between the two techniques. The authors noted transPRK to be minimally invasive with a quicker recovery, but PRK is reliable and advantageous when there is not affordable advanced technology. “The choice of laser platform can also influence the surgical outcomes through features such as advanced pulse technology, optimized ablation speed, and profiles,” they wrote.

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