Topline results from Phase 3 study of atropine for myopia progression

Vyluma announced positive Phase 3 results from its CHAMP (Childhood Atropine for Myopia Progression) study. This multicenter, international study involved 3 years of treatment and follow-up, demonstrating safety and efficacy of NVK002, a low-dose, preservative-free atropine drop. According to the company’s press release, “CHAMP is the largest and longest placebo-controlled, prospective pediatric myopia study conducted to date.” The study evaluated NVK002 compared to placebo in the following areas: responder analysis, mean change from baseline in spherical equivalent refraction, and mean change from baseline in axial length at 36 months. The 0.01% dose demonstrated statistically significant and clinically meaningful differences compared to placebo in these areas, the company stated. The 0.02% dose showed efficacy and statistically significant mean change in axial length compared to placebo at 36 months, but responder analysis was not statistically significant. There were no serious adverse events with either dose of NVK002. The company plans to submit an NDA to the FDA in the first quarter of 2023. If approved, NVK002 would be the first FDA approved pharmaceutical for treatment of pediatric myopia progression.

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Phase 3 results for novel glaucoma drop

Nicox announced Phase 3 results for its once-daily NCX 470 0.1% for IOP lowering. NCX 470, according to the company, is a novel, nitric oxide-donating bimatoprost eye drop. In the Phase 3 study, the investigational drop was compared to latanoprost 0.005% (standard of care). The study included 691 patients with open-angle glaucoma or ocular hypertension. The IOP lowering from baseline in the NCX 470 group was 8.0–9.7 mm Hg, compared to 7.1–9.4 mm Hg in the latanoprost group. Non-inferiority (the primary endpoint) was met. The company stated that NCX 470 did not achieve statistical superiority in time-matched change from baseline IOP (a secondary endpoint), but the IOP reduction was greater than latanoprost at all timepoints. A second, similar Phase 3 trial is ongoing in the U.S. and China with topline results expected after 2024.

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Positive results from two Phase 3 studies for patients with RVO

Genentech announced positive topline results from two Phase 3 studies that evaluated Vabysmo (faricimab-svoa) for macular edema due to branch and central retinal vein occlusion (RVO). The company’s press release stated that Vabysmo achieved the primary endpoint of non-inferiority to aflibercept in RVO. Patients in the studies had macular edema due to RVO and received Vabysmo injections every 4 weeks for up to 24 weeks. The company described Vabysmo as the first and only currently FDA-approved product for wet AMD and DME that targets and inhibits two disease pathways involving Ang-2 and VEGF-A.

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Phase 3 results for cell therapy treating macular telangiectasia type 2

Neurotech Pharmaceuticals released the results from two Phase 3 clinical trials for the NT-501 implant, an investigational encapsulated cell therapy for treatment of macular telangiectasia type 2. The research found clinically relevant and statistically significant results with the implant, according to the press release. These included a 56.4% rate of reduction with one of the study’s protocols and a 29.2% rate of reduction with the study’s other protocol. These results, the company stated, “are the first Phase 3 clinical validations demonstrating preservation of photoreceptors with a novel ophthalmic neuroprotectant therapy.” The company described NT-501 as a cylindrical membrane that encapsulates human epithelial cells that are genetically engineered to produce ciliary neurotrophic factor.

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Single injection of investigational compound for DME improves BCVA

Phase 2 results of a single injection of an investigational compound for treatment of DME (UBX1325, UNITY Biotechnology) achieved a statistically significant and clinically relevant improvement in BCVA. According to UNITY Biotechnology’s press release, UBX1325 was compared to sham in this Phase 2 trial, maintaining a stabilized retinal structure with patients gaining 7.6 ETDRS letters at 24 weeks compared to sham. More patients remained rescue-free in the treatment arm (59.4%) compared to sham (37.5%) as well. Prior to receiving the investigational UBX1325, patients were on anti-VEGF therapy for at least 6 months (the last anti-VEGF injection was 3–6 weeks before randomization in the study).

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FDA accepts BLA for ophthalmic bevacizumab

Outlook Therapeutics announced that the FDA accepted its Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg). According to the company’s press release, this drug, if approved, would be the first ophthalmic formulation of bevacizumab for retinal indications. The Prescription Drug User Fee ACT goal date is August 29, 2023.

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Mobile phone attachment developed for ophthalmic clinical trials

Ora launched Ora EyeCup as a mobile research platform that can capture high-resolution imaging, includes AI analysis, and provides real-time patient feedback. According to the company’s press release, this system features a smartphone attachment and a software application that can be used to track signs and symptoms of disease remotely. The company explained that images can be processed post-capture with the program’s AI-powered image analysis, which can assess ocular redness, tear film stability, and corneal health. The company stated that the Ora EyeCup is made to enhance the quality of ophthalmic clinical trials.

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ASCRS news and events

• 2023 ASCRS Educator Award: ASCRS is accepting nominations for its Educator Award, which will be given at the 2023 ASCRS Annual Meeting. Submit a nomination here.
• 2023 ASCRS Annual Meeting: Hotel blocks in San Diego, California, for the Annual Meeting are open now. Early bird registration opens November 21. Learn more.
• EyeWorld magazine: A new EyeWorld Online Exclusive is available on the website, featuring the topic of “drug repurposing” research and non-antibiotic therapy for endophthalmitis.

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Research highlights

• A retrospective case series published in the Journal of Cataract & Refractive Surgery sought to compare the safety and efficacy of topical corticosteroids with an intracanalicular option. The study included patients who received either topical prednisolone acetate 1 mg/1 mL for inflammation prophylaxis or dexamethasone intracanalicular insert (Dextenza, Ocular Therapeutix). Patients were seen at 1 day, 1 week, and between 4–16 weeks postop. The patient chart review identified 262 patients who met inclusion criteria; 131 received topical prednisolone and 131 received the intracanalicular insert. According to the paper, nine eyes experienced breakthrough inflammation in the drops group (6.9%) and 12 in the intracanalicular insert group (9.2%). Two eyes in the drops group and one in the intracanalicular insert group had elevated IOP. The authors concluded that the insert “may be associated with similar rates of breakthrough inflammation and IOP elevation as topical drops.”
• The prevalence and incidence of dry eye and meibomian gland dysfunction in the U.S. were evaluated in a systematic review and meta-analysis published in the journal JAMA Ophthalmology. The review, which included Ovid MEDLINE and Embase as data sources, found that pooled prevalence of dry eye was 8.1%, and incidence ranged from 3.5–7.8%. Pooled prevalence of MGD was 21.2%. The authors wrote that this review and analysis showed “uncertainty about the prevalence and incidence of dry eye and MGD” in the U.S. The authors advocated for more population-based epidemiological studies with consistent, validated definitions for dry eye and MGD in order to provide higher-certainty estimates of these conditions.

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Product news

• ILUVIEN (fluocinolone acetonide intravitreal implant, Alimera Sciences) was granted reimbursement in the Czech Republic.

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