FDA approves treatment for macular edema following RVO

The FDA approved Eylea HD (aflibercept injection 8 mg) for treatment of macular edema following retinal vein occlusion (RVO), Regeneron Pharmaceuticals announced in a press release. Eylea HD is approved for dosing every 8 weeks after an initial monthly dosing period. Monthly dosing is still an option for all approved indications, which include wet AMD, diabetic macular edema, diabetic retinopathy, and RVO, according to the company.

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New cyclosporine product receives approval for dry eye

Amneal Pharmaceuticals announced FDA approval of the company’s cyclosporine ophthalmic emulsion, 0.05%, as a generic equivalent to RESTASIS, 0.05% (Allergan). The newly approved drop for dry eye is preservative free and delivered via single-use vials.

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First human implant of 3D-bioprinted cornea

Precise Bio announced the successful first in-human implantation of its 3D-bioprinted cornea, PB-001. According to the company’s press release, this milestone in the ongoing Phase 1 trial was performed on a patient who was legally blind, and it “marks the world’s first transplant of a cell based, functional 3D-bioprinted cornea.” The Phase 1 trial is assessing safety and tolerability of PB-001 in up to 15 patients with corneal edema due to endothelial dysfunction. Efficacy will be evaluated out to 6 months. Topline results are expected in the second half of 2026.

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Topline results from Phase 3 trial for Stargardt disease

Belite Bio announced topline results from its Phase 3 trial of tinlarebant in adolescent patients with Stargardt disease type 1 (STGD1). According to the company’s press release, the trial, which included 104 patients, met its primary efficacy endpoint with a statistically significant and clinically meaningful 36% reduction in retinal lesion growth rate, compared to placebo. The company reported that the overall change in visual acuity was minimal over the 24-month study period, which was expected. The treatment was well-tolerated, resulting in 4 treatment-related discontinuations. According to the company, this is the “first successful pivotal trial in patients with [STGD1].” Tinlarebant is an oral therapy that in the study was taken daily. It’s designed to “reduce the accumulation of vitamin A-based toxins (also known as bisretinoids) that cause retinal disease.” In the U.S., tinlarebant has a Breakthrough Therapy Designation, a Fast Track Designation, and Rare Pediatric Disease Designation.

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First patient treated with IDE glaucoma therapy

ViaLase announced that the first patient has been treated in the Investigational Device Exemption (IDE) clinical trial with its femtosecond laser trabeculotomy procedure. According to the company’s press release, the trial is prospective, multicenter, randomized, and controlled to compare the ViaLase procedure to SLT.

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Enrollment complete for Phase 2 trial for geographic atrophy treatment

Inflammasome Therapeutics has enrolled 30 patients with bilateral geographic atrophy at nine U.S. centers for the Phase 2 dose-ranging (0.3, 0.7, or 1.05 mg) trial that is evaluating its dual inflammasome inhibitor for geographic atrophy known as K8. Enrolled patients receive a 3-month biodegradable implant in one eye, while their other untreated eye serves as a control. After 3 months, according to the company’s press release, patients receive a second intraocular implant and are followed for an additional 3 months. The primary endpoints are safety and change in geographic atrophy lesion size growth.

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First patient implanted with investigational glaucoma shunt in trial

Avisi Technologies announced that the first patient for its prospective, multicenter, open-label clinical trial has been implanted with the VisiPlate aqueous shunt. This study is intended to assess the safety and efficacy of the VisiPlate—created with a metamaterial that’s thinner than a human hair—in patients with open-angle glaucoma. According to the company’s press release, the trial will enroll about 65 patients. The primary endpoint is proportion of participants who achieve a clinically significant reduction in diurnal IOP at 12 months compared to baseline on the same or fewer glaucoma medications.

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Positive review of Phase 3 pivotal trial for AMD

EyePoint Pharmaceuticals announced its second planned independent Data Safety Monitoring Committee review for the Phase 3 program for DURAVYU as a treatment for wet AMD. The Committee recommended that both Phase 3 trials continue as planned with no protocol modifications.

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Company news

• Ripple Therapeutics entered into an evaluation program and licensing option agreement with an affiliate of Bausch + Lomb to develop sustained-release drug delivery implants.

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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

• Compounded imiquimod 5% was evaluated as a possible treatment for diffuse conjunctival melanoma in situ (MIS) or ocular surface squamous neoplasia (OSSN). This interventional case series of 5 patients was performed because, according to the authors of the paper published in JAMA Ophthalmology, there are limited treatment options for these conditions. Current treatment options include mitomycin C for MIS and 5-fluorouracil for OSSN. In the study, compounded imiquimod 5% ointment was applied to the conjunctival surface 5 days a week for at least 12 weeks alongside a topical antibiotic. The authors reported that after 12 weeks of treatment “there was complete clinical and histological response of CIN [conjunctival intraepithelial neoplasia] with moderate dysplasia, partial histological response (downgrade from squamous cell carcinoma to CIN with moderate dysplasia), and no histological recurrence of positive margins of squamous cell carcinoma excision.” They reported a partial clinical response in diffuse MIS, but complete histological response in the area of the initial map biopsy. At 15 weeks, there was complete clinical and histological response in the case of conjunctival melanoma with adjacent clinical primary acquired melanosis. In all cases, the ophthalmic adverse events affected only the ocular surface and eye lids, and all adverse events were resolved within 1–2 weeks of pausing treatment or completing treatment. The authors acknowledged that “definitive safety and efficacy cannot be determined across only 5 cases,” but they wrote that “compounded imiquimod 5% ointment may be a safe and effective approach to manage diffuse conjunctival MIS or OSSN.”
• Use of the Light Adjustable Lens (LAL, RxSight) in a combined cataract and pterygium surgery, traditionally separated procedures, was evaluated in a retrospective, observational study published in the Journal of Cataract & Refractive Surgery. The study included 18 eyes from 14 patients who had concurrent pterygium and cataract removal with IOL implantation. Mean spherical equivalent improved to –0.29 D at 3 months postop. Nine eyes achieved a spherical equivalent of less than 0.25 D, and 15 eyes achieved a spherical equivalent of less than 0.5 D. Mean UDVA improved to 0.096 logMAR, while refractive astigmatism was significantly reduced. The authors concluded that these simultaneous procedures with use of the LAL could be a viable alternative for the logistical issues that can occur with keeping the procedures separate. “The adjustability of the LAL mitigates refractive unpredictability caused by corneal irregularities,” they wrote.

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