FDA accepts BLA for thyroid eye treatment

The FDA has accepted Viridian Therapeutics’ Biologics License Application (BLA) for veligrotug for treatment of thyroid eye disease, giving it priority review and a Prescription Drug User Fee Act (PDUFA) target action date of June 30. According to the company’s press release, the BLA is supported by two Phase 3 clinical trials, which it notes were the largest to date for thyroid eye disease. Veligrotug met all primary and secondary endpoints in both studies, for the first time “[demonstrating] statistically significant diplopia response and diplopia resolution.” Veligrotug is administered in five intravenous infusions, with treatment complete in 12 weeks.

Back to top

Breakthrough Therapy Designation granted to investigational neuroprotective for optic neuropathies

Oculis announced that it received a Breakthrough Therapy Designation from the FDA for privosegtor for treatment of optic neuritis. According to the company’s press release, privosegtor is a peptoid small molecule that can cross the blood-brain and retinal barriers, giving it the potential to be “the first neuroprotective therapy for optic neuropathies.” This designation, according to the company, is supported by its Phase 2 trial that found privosegtor “delivered substantial improvement in [low contrast visual acuity] along with consistent anatomical and biological benefits compared with placebo.” The company has begun a Phase 3 pivotal trial program that includes three studies for optic neuritis and NAION. The first trial began in the fourth quarter of 2025, with enrollment expected to begin soon.

Back to top

FDA issues complete response letter for wet AMD BLA resubmission

The FDA has issued another complete response letter to Outlook Therapeutics’ Biologics License Application (BLA) resubmission for ONS-5010/LYTENAVA (bevacizumab-vikg). According to the company’s press release, the complete response letter “noted that the additional mechanistic and natural history data information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application.” The company noted that the “FDA has not indicated what type of confirmatory evidence would be acceptable.” The company stated its intent to continue “exploring all available pathways for potential approval in the U.S. and [its intent] to continue its efforts to expand into additional markets in Europe and other regions.” LYTENAVA has marketing authorization in the E.U. and the U.K. for treatment of wet AMD.

Back to top

Biosimilar approved for retinal therapies

Formycon and Bioeq received FDA approval for Nufymco (ranibizumab-leyk) as an interchangeable biosimilar to Lucentis. According to the company’s press release, Nufymco will be available for all approved indications for Lucentis in the U.S., including wet AMD, diabetic macular edema, macular edema following retinal vein occlusion, diabetic retinopathy, and myopic choroidal neovascularization.

Back to top

FDA approves IND for corneal genome editing program

GenEditBio received FDA approval for its Investigational New Drug (IND) application to begin a Phase 1/2 trial for its in-vivo genome-editing program for treatment of TGFBI corneal dystrophy. The trial will evaluate safety, tolerability, and efficacy of GEB-101 in patients with corneal dystrophy due to a TGFBI mutation. The treatment consists of one intrastromal injection. Patient enrollment will begin in the second quarter of this year.

Back to top

Study: ‘largest prospective trial ever’ on postcataract endophthalmitis prophylaxis

The latest issue of the Journal of Cataract & Refractive Surgeryincludes a multicenter, randomized, prospective study investigating the efficacy of intracameral moxifloxacin, 0.5%, for endophthalmitis prevention in cataract surgery. The study took place at three tertiary eye centers in northern India and included 60,000 eyes having phacoemulsification cataract surgery. The eyes were randomized to group 1, receiving intracameral moxifloxacin, and group 2, not receiving any intracameral antibiotics and serving as the control. The authors found that six eyes (0.02%) in group 1 developed endophthalmitis, while there were 16 cases (0.05%) in group 2, making endophthalmitis 2.5x lower with intracameral antibiotics. Endothelial cell counts were similar in the preop and postop period between the two groups. The investigators concluded that “intracameral moxifloxacin is safe and effective in preventing postcataract surgery acute bacterial endophthalmitis.” William J. Dupps Jr., MD, PhD, FARVO, co-editor-in-chief for the journal, wrote in a letter from the editor that this was the “largest prospective randomized trial ever published on prophylaxis for postcataract surgery endophthalmitis.” He wrote that the study “does not address the effectiveness of intracameral administration alone when not performed in combination with topical antibiotics. However, for the same reason, the design provides a strong causal inference for the independent effect of intracameral moxifloxacin over drops alone.”

Back to top

Complimentary access to video journal

The latest issue of the Video Journal of Cataract, Refractive, & Glaucoma Surgery, founded and edited by Robert Osher, MD, is online now.

Back to top

Company news

• After not receiving enough stockholder votes to approve a merger agreement with Alcon, STAAR Surgical stated in a press release that it intends to terminate this agreement.

Back to top

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 due January 16—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.

Back to top

Research highlights

• Patients’ subjective experience in second eye surgery compared to first eye during immediate sequential bilateral cataract surgery (ISBCS) was reported in a survey-based, prospective study published in the Journal of Cataract & Refractive Surgery. Patients reported the pain level in the second surgery to be significantly greater than the first eye surgery. The authors reported that “order of surgery” was a greater predictor of pain than surgical length, additional anesthesia, patient age, or patient sex. Patients reported the first eye surgery being more comfortable and feeling shorter. With this information, the authors concluded that “understanding differential experiences between eyes can help surgeons when counselling patients regarding expectations for ISBCS and related visual outcomes.”
• Efficacy and safety of Hydrus Microstent (Alcon) and three iStent inject W (Glaukos) were compared in a real-world setting with more than 3 years of follow-up. The prospective, consecutive, longitudinal study published in the journal Eye included 105 cases where Hydrus (n=56) or three iStent inject W (n=49) were implanted at the time of cataract surgery at a single private practice in Australia. After 3 years postop, the mean IOP reduction in the Hydrus group was 2.6 mm Hg (from 15.1 mm Hg to 12.5 mm Hg) and 2.0 mm Hg in the iStent W group (from 15.2 mm Hg to 13.2 mm Hg). There were no significant differences between the groups in estimated changes in mean IOP from preop to postop year 1, 2, or 3. There were significant reductions in the estimated mean number of medications in both groups at 3 years, according to the authors, though the change in mean number of medications from preop was not statistically significant between the groups. In the Hydrus group, 54.3% of eyes were medication free at 3 years and 61.2% were medication free in the iStent inject W group. From a safety standpoint, there were no significant complications. With this, the authors concluded that “surgeon preference may guide device selection, with specific considerations for patients such as extremes of ocular size or anticoagulation therapy.”

Back to top

---