Investigational drug-eluting contact lens for glaucoma sees positive results

A Phase 2b Group 1 (low dose) study of a drug-eluting contact lens for glaucoma and ocular hypertension being developed by MediPrint Ophthalmics showed positive results. In the trial, 11 patients who were not prior contact lens wearers wore the LL-BMT1 contact lens for 3 weeks; the contact lens was replaced every 7 days. Interim analysis showed that the low-dose drug-eluting lens achieved a clinically meaningful reduction in IOP of about 5.5 mm Hg compared to the reference treatment. There were no serious treatment-related adverse events, and the lenses were well tolerated. The company plans on moving forward with a Phase 2b Group 2 study that will evaluate a medium dose of LL-BMT1.

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First clinical-stage RNA-targeting therapy for nAMD

HuidaGene Therapeutics announced that the FDA has accepted its investigational new drug application for neovascular AMD, making it the “first-ever clinical-stage CRISPR/Cas13 RNA-editing and the only clinical-stage RNA-targeting therapy for nAMD,” according to the company. In preclinical studies in a mouse model, HG202 reduced CNV area by 87%, more than both anti-VEGF therapy and AAV-anti-VEGF gene therapy. The company’s Phase 1 open-label, multicenter, dose-finding trial will evaluate safety and tolerability of the RNA-editing therapy, which targets knockdown of VEGF-A mRNA (Hg202) in patients with nAMD.

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PDUFA data extended for BLA for treatment of macular telangiectasia

Neurotech Pharmaceuticals announced that the FDA extended its PDUFA goal data for review of its biologics license application for its investigational treatment (NT-501, revakinagene tarortcel) of macular telangiectasia. The new PDUFA goal date is March 18, 2025. The extension was granted to allow the agency review of additional data provided by the company. NT-501 is an encapsulated cell therapy that will deliver CNTF for treatment of retinal diseases.

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Three rare disease designations granted to investigational gene therapy treatments

MeiraGTx announced, in a Q3 financial and business update, that it received three Rare Pediatric Disease Designationsfrom the FDA for its three potential therapies for three different rare inherited retinopathies, including LCA4 retinal dystrophy, Bardet-Biedl syndrome due to BBS10 mutations, and RDH12-associated retinal dystrophy.

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Partnership and acquisition news

• Avant Technologies and Ainnova Tech entered into a joint venture and licensing agreement, forming Ai-nova Acquisition Corp to advance and commercialize the Ainnova VisionAI platform and Versatile Retina Cameras.
• Harrow announced a multi-year partnership with Asembia to expand access to several of Harrow’s ophthalmic branded products.
• AlloVir and Kalaris Therapeutics, a clinical-stage biopharmaceutical company founded by Samsara BioCapital, entered into a definitive merger agreement with AlloVir acquiring all outstanding equity interest in Kalaris.
• Clearside Biomedical entered into a commercial collaboration agreement with Santen Pharmaceutical for AVRN001 (branded as XIPERE in the U.S.) for treatment of uveitic macular edema. The rights will be granted to Santen for commercialization of the product candidate in China (excluding Taiwan, Hong Kong, and Macau).
• Nippon Shinyaku and Atsena Therapeutics entered into an exclusive license agreement for commercialization of ATSN-101 in the U.S. and for commercialization and development of ATSN-101 in Japan. This is a gene therapy targeting Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1).

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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.
• ASCRS Live!: This educational dinner series has made its way to several cities across the U.S. this year. Registration is open for the final event of 2024 in Denver, Colorado, on December 5. Stay tuned for information about 2025 in-person events.
• 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 pilot laboratory study published in the Journal of Cataract & Refractive Surgery sought to evaluate the effect of temperature on rheology of ophthalmic viscosurgical devices, as well as any clinical implications. The study evaluated three OVDs (Eyefill-SC/Eyefill-C/Eyefill-HD), which were measured using rotational and extensional rheometers at 5 degrees C, 25 degree C, and 37 degrees C. Thermal properties were evaluated using differential scanning calorimetry and laser-flash analysis. The investigators found viscosities and relaxation time to be higher at lower temperatures. “An increase in temperature led to a decrease in relaxation time under shear and extension,” they wrote. The study, according to the authors, “confirms our clinical experience that OVD properties are affected by low temperatures, with increased viscosities at low shear rates and higher relaxation times. … Excessively forced injection using cold OVD could contribute to inadvertent cannula detachment if incorrectly assembled, or uncontrolled IOL release leading to avoidable injury.”
• The sustainability of IOP reduction provided by continuous negative pressure over an extended duration with the Ocular Pressure Adjusting Pump was evaluated in a prospective, controlled, open-label, randomized pilot study. Nine subjects completed the study, which was published in the journal Clinical Ophthalmology. One eye was randomized to negative pressure application (–12 mm Hg) over 8 consecutive hours and the other eye served as control. IOP measurements were taken at 2-hour intervals. The mean IOP reduction in the study eye from baseline at 0, 2, 4, 6, and 8 hours was 8.1 (37%), 6.4 (28%), 6.3 (29%), 7.3 (34%) and 6.7 mm Hg (31%), respectively. The authors reported no serious adverse events.

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Product news

• Harrow’s VEVYE (cyclosporine ophthalmic solution), 0.1%, on January 1, 2025, “will be included in key formularies managed by major plan sponsors such as Express Scripts, Cigna, Kaiser Permanente, and CVS Caremark.” It currently has coverage through all Medicaid programs and 60% commercial insurance coverage.

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