FDA approves continuous delivery treatment for DME

Genentech announced that it received FDA approval for Susvimo (ranibizumab injection) 100 mg/mL for treatment of diabetic macular edema (DME). According to the company’s press release, the approval makes Susvimo the “first and only continuous delivery treatment that offers an alternative to regular injections” for DME. The company stated that as few as two treatments per year are needed for some patients to maintain their vision. This is the second indication approved for Susvimo (the first being for wet AMD).

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Positive topline data from Phase 2 trials for new glaucoma treatment

Qlaris Bio announced positive topline results from two of its Phase 2 clinical trials investigating QLS-111—an ATP-sensitive potassium channel modulator platform that, according to the company, “[relaxes] vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering [episcleral venous pressure]”—in patients with primary open angle glaucoma and ocular hypertension. One randomized, masked trial assessed safety, tolerability, and IOP activity in a range of doses compared to vehicle. The 0.015% concentration resulted in the greatest IOP reduction (mean –3.7 mm Hg from a mean diurnal baseline of 20.3 mm Hg). The second randomized and masked study assessed safety, tolerability, and additive IOP lowering of QLS-111 (0.015%) dosed with latanoprost compared to latanoprost alone. Patients in the QLS-111 plus latanoprost group achieved greater IOP reductions (3.2 mm Hg greater with QPM dosing and 3.6 mm Hg greater with BID dosing).

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Positive 6-month data from clinical trial evaluating drug delivery for treatment of DME

EyePoint Pharmaceuticals announced positive 6-month results from its clinical trial evaluating two doses (1.34 mg and 2.7 mg) of DURAVYU in patients with DME. According to the company’s press release, there were no treatment-related ocular or systemic adverse events at either dose. The primary endpoint—extending time to first supplemental injection compared to aflibercept control—was achieved for both doses. Additionally, the 2.7 mg dose resulted in a 7.1 letter gain at 24 weeks and a 76-micron reduction in central subfield thickness. There was also a reduced treatment burden. The company plans to begin its Phase 3 non-inferiority pivotal trial by the end of this year. DURAVYU (vorolanib intravitreal insert) is designed to provide sustained drug delivery of the selective tyrosine kinase inhibitor via the bioerodible Durasert.

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Pivotal study evaluating AI algorithm for neovascular AMD with home OCT published

The results of Notal Vision’s pivotal study evaluating its AI algorithm for estimating key biomarkers of neovascular AMD with home OCT were published in the journal Ophthalmology Science. According to the company’s press release, the results of this study led to the first FDA clearance of an AI algorithm for OCT images. The study involved 336 patients with neovascular AMD from six U.S. clinics; the press release noted the diverse, co-existing pathologic features among the patients that would challenge the AI algorithm. In the study, patients took four images each on two home OCT devices, in addition to being imaged in the office and analyzed by professional graders for comparison purposes. The company reported that the algorithm was successful with high repeatability in estimating total retinal hypo-reflective space volumes based on home OCT images and agreed with expert graders in segmenting hypo-reflective spaces.

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Regenerative Medicine Advanced Therapy designation granted to X-linked retinitis pigmentosa treatment

Beacon Therapeutics announced that it received a Regenerative Medicine Advanced Therapy designation from the FDA for its X-linked retinitis pigmentosa (XLRP) treatment, laru-zova (laruparetigene zovaparvovec). This designation, according to the company’s press release, “recognizes preliminary clinical evidence from the Phase 2 DAWN and SKYLINE trials evaluating the efficacy, safety, and tolerability of laru-zova in patients with XLRP caused by mutations in the RPGR gene.”

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Promising results for ophthalmic gel to treat geographic atrophy

SeaBeLife announced positive, pre-clinical, in vivo results for its drug candidate, SBL03, an investigative ophthalmic gel to treat geographic atrophy. The pre-clinical animal model, which had retinal degeneration-like geographic atrophy induced, was treated with SBL03 for several days. The investigators found that the treatment was able to reach retinal tissue in adequate concentration, and the treated eyes showed “significant protection of the structural and functional integrity of the retina.” According to the company’s press release, “the various parameters examined were correlated and show that repeated topical ocular treatment with SBL03 has a protective effect against retinal degeneration compared with placebo.” SBL03 is described as a “dual inhibitor of regulated necrotic cell death.”

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Recruitment complete in trial for continuous range-of-vision IOL

Rayner announced that it has completed recruitment for its Investigational Device Exemption for its RayOne Galaxy IOL, which it described as the “world’s first spiral IOL” that was “developed with AI to deliver a smooth and continuous full range of vision with minimal dysphotopsia.”

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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 Preview 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.
• The Winning Pitch Challenge: The Winning Pitch Challenge ahead of the ASCRS Annual Meeting will be back on April 24 in Los Angeles, California. Submissions for innovative ideas that could impact the future of eyecare are being accepted now through February 14. Cash prizes for winners are worth up to $25,000. Find more information on submissions here.
• 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. Stay tuned each week through April 2025 for a new video.

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Research highlights

• A case series of 9 patients, published in JAMA Ophthalmology, shared some ophthalmic complications that could be related to the use of semaglutide or tirzepatide, drugs that have seen a recent increase in prescriptions for diabetes and weight loss. According to the paper, a causal link between these drugs and the ophthalmic complications cannot be established, and the authors wrote that the “findings cannot rule out the possibility that rapid correction of hyperglycemia may be associated with the results reported.” The ophthalmic complications included 7 patients experiencing non-arteritic ischemic anterior optic neuropathy, 1 patient with bilateral papillitis, and 1 patient with paracentral acute middle maculopathy. The authors noted that atypical features among the patients included “sequential ischemic optic neuropathy, bilateral disc swelling at presentation, and progressive vision loss.”
• The 6-month visual and refractive outcomes of keratorefractive lenticule extraction (KLEx) was compared to LASIK and PRK in a military population. The retrospective study published in the Journal of Cataract & Refractive Surgeryevaluated 737 eyes treated with KLEx, 2,801 treated with PRK, and 928 treated with LASIK. There were no statistically significant differences between the three procedures in eyes achieving UDVA of 20/20 or better by postop month 7. At postop month 1, more eyes in the KLEx group achieved the same or 1 line better in distance visual acuity than in the PRK group. Efficacy indices at postop month 6, according to the paper, were 1.09, 1.10, and 0.97 for KLEx, PRK, and LASIK, respectively. Safety indices were 0.96, 1.01, and 0.81, respectively. The authors concluded that “[after] the initial recovery period, KLEx demonstrates comparable outcomes in efficacy, safety, and accuracy as compared with LASIK and PRK.”

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