Proof-of-concept trial for intravitreal implant for glaucoma patients

Perfuse Therapeutics announced 24-week data from its Phase 1/2a trial evaluating PER-001 as a treatment for patients with glaucoma. The intravitreal implant carrying a “first-in-class small molecule endothelin receptor agonist,” according to the company, which is “the most potent vasoconstrictor in the human body and is upregulated in glaucoma,” was found in the trial to have promising functional and structural outcomes. The trial evaluated a Phase 1 dose (n=6) and a Phase 2a dose 1 cohort (n=12), finding the single treatment to be well tolerated (the one drug-related adverse event was mild, transient floater) and efficacious. Patients treated with PER-001 had a mean increase in optic nerve head blood flow of at least 10% from baseline, sustained to week 24, according to the company’s press release. The company also reported a mean improvement in visual field mean deviation of 1 dB/year and a mean increase in retinal nerve fiber layer thickness of 3 microns at week 24. The control/sham group had a 0.63 dB/year decline in visual field mean deviation and a decrease in retinal nerve fiber layer thickness of 1.3 microns. The Phase 2a dose 2 cohort study is ongoing, and topline data is expected in the second quarter of 2025. According to the company’s press release, PER-001 is bioerodible and designed for dosing every 6 months.

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Phase 3 study evaluating intravitreal gene therapy for wet AMD

Adverum Biotechnologies announced that it was beginning a Phase 3 study to evaluate the safety and efficacy of Ixo-vec (ixoberogene soroparvovec), a one-time intravitreal injection of a gene therapy, for treatment of wet AMD. According to the company’s press release, this pivotal, U.S.-based study will compare one injection of Ixo-vec (6E10 vg/eye) to aflibercept (2 mg) injected every 8 weeks. The study plans to enroll approximately 284 patients with wet AMD, including treatment naïve and previously treated patients. The primary endpoint will be mean change from baseline in BCVA at 1 year with a non-inferiority margin of –4.5 letters. The company reported that all patients will receive 3 loading doses of aflibercept prior to Ixo-vec, per FDA guidance. Both arms will be eligible to receive supplemental injection of aflibercept and prophylactic steroid eye drops. This is the first of two planned Phase 3 registrational trials of the treatment for this indication.

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New analysis shows differentiation of investigational glaucoma treatment

Nicox announced new analysis from its Phase 3 trial of NCX 470, noting that it shows differentiation of the investigational treatment compared to the standard of care. According to the company’s press release, more patients in the NCX 470 group achieved an IOP of 18 m Hg or less compared to those in the standard-of-care latanoprost group. The company also reported a greater mean percent IOP reduction from baseline in eyes treated with NCX 470 compared to latanoprost. The company stated that it is on track for a New Drug Application submission in the first quarter of 2026.

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IND studies to investigate gene therapy for dry AMD

Avirmax Biopharma announced that it was beginning “Investigational New Drug (IND)-enabling studies” for ABI-201, which it described as a “potential first-in-class AAV vector that delivers three genes to correct the dysregulation of complement activation, anti-inflammation, to protect retinal pigment epithelia and photoreceptors as well as to block retinal neovascularization.” This investigational treatment for dry AMD is designed to require a single intravitreal injection to prevent retinal pathology and preserve vision. So far, in vivo studies have been conducted on multiple animal models, according to the company. The company anticipates submitting an IND in the fourth quarter of 2025 and, pending approval, beginning a Phase 1/2a trial in humans with dry AMD shortly thereafter.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California. Find the most up-to-date information on the Real-Time Program here.
• SightLine at ASCRS: This is a new day-long meeting April 24, ahead of the ASCRS Annual Meeting, for all commercial stakeholders in ophthalmology to learn about and collaborate on technologies and 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 24 from 1:00–5:30 p.m. in Los Angeles ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Tune in each week through April 2025 for a new video.

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Research highlights

• A cross-sectional study published in the Journal of Cataract & Refractive Surgery assessed the 5-year trends in the rate of immediate sequential bilateral cataract surgery (ISBCS) and “surgeon characteristics associated with performing ISBCS.” According to the paper, which included Medicare fee-for-service beneficiaries from 2018–2022, there were 3,954 cases of ISBCS (0.33%) among 1,190,169 cases of bilaterally performed cataract surgery (BPCS). The authors reported a quarterly rate increase of ISBCS from 2.12 to 5.5 per 1,000 BPCS cases. The study included 10,290 surgeons, 10.87% of whom performed ISBCS (1,119). Among the surgeons who performed ISBCS, the proportion of ISBCS cases per 1,000 BPCS cases doubled from 17.20 in 2018 to 35.5 in 2022. The authors reported that surgeons in the highest surgical volume quartile, recent graduates, and surgeons in the West were more likely to perform ISBCS. Overall, the authors concluded that the increased rate of ISBCS over the study’s period of time possibly suggests a greater interest among patients and surgeons.
• A retrospective comparison study published in the journal Ophthalmology compared early exposure and surgical revision rates between the CorNeat EverPatch (CorNeat Vision), which is a synthetic tissue substitute, and traditional human donor corneas. The study also evaluated the biomaterial properties of EverPatch. All patients included in the study had surgery at a single center in the U.S. from February–August 2024. The comparison group received an irradiated donor cornea and were matched 1:2 with patients receiving EverPatch for age, glaucoma type, and surgeon. Thirty patients received EverPatch during primary tube shunt placement (n=27), tube shunt revision (n=2), or to cover an exposed suture for a scleral fixated IOL (n=1). The rate of EverPatch exposure within 5 months postop was 48.3%, and surgical revision rate was 27.9%. The rate of patch-graft exposure for the case-matched controls was 1.7%, and surgical revision rate was 1.7%. Analysis of the explanted EverPatch devices showed varying degrees of tissue integration with “significantly increased wettability and changes in thermal stability and elemental composition.”

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Product news

• The VISUMAX 800 (Zeiss) with SMILE pro software is now available in China.
• Haag-Streit launched the METIS 900 ophthalmic microscope.
• ForSight Robotics announced ISO 13485:2016 certification, which the company considers a milestone for its ORYOM Platform, advancement toward its patient trials, and future regulatory approvals.

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