Clinical Trials
1
0 active
Approvals
0
Total approvals
Agencies
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Regulatory bodies
Founded
1979
No trial phase data available
Recruiting
1
100.0%
No approval data available
- A large retrospective analysis of 34,590 thyroid eye disease patients found that 30% experienced disease progression during follow-up, challenging the traditional self-limited disease model. - The cumulative incidence of TED progression reached 31% at 5 years and 39% at 8 years, with notable variability in progression timing across patients. - The findings suggest TED has a more chronic, heterogeneous course than previously understood, highlighting the need for ongoing monitoring beyond the acute phase. - This real-world evidence reinforces the importance of early detection and appropriate thyroid function testing in clinical practice.
- A Phase 3 clinical trial showed epithelium-on corneal cross-linking achieved a full 1-diopter difference between treatment and sham groups, with the treatment group demonstrating half-diopter corneal flattening at 12 months. - The innovative procedure uses specialized oxygen-enriched goggles maintaining over 90% oxygen concentration to enable efficient aerobic cross-linking while preserving the epithelial layer. - The safety profile was exceptional with no serious adverse events reported, eliminating risks associated with traditional epithelium-off approaches including infection, delayed healing, and scarring. - The technique may expand treatment eligibility to patients with thinner corneas or those at risk of surface disease by significantly reducing procedural risks.
- BVI's FINEVISION HP trifocal intraocular lens has received FDA approval for the US market, expanding advanced IOL options for American ophthalmologists and their patients. - The lens has been implanted in millions of procedures globally over 15 years and features diffractive optic design supporting vision at far, intermediate, and near distances. - A phased US rollout is planned starting fall 2025, with broader distribution expected in the first six months of 2026 as BVI scales manufacturing to meet anticipated demand. - The approval is supported by US clinical study data (NCT04176965) and represents a significant expansion of BVI's premium IOL portfolio in the American market.
- The FDA has approved Rayner's RayOne EMV Toric intraocular lens, marking a significant advancement in astigmatism correction for cataract patients. - Clinical trial results demonstrated exceptional rotational stability with 99% of eyes rotating ≤5° at 6 months, exceeding FDA requirements. - The lens features a patented non-diffractive optic design with controlled positive spherical aberration, delivering monofocal-level contrast sensitivity. - The approval follows successful completion of a multicenter FDA trial involving 238 patients comparing the toric IOL to a control monofocal lens.
- Verana Health has enhanced its Site Explorer application to identify clinical trial sites based on racial and ethnic patient demographics, leveraging data from 80 million de-identified patients. - The upgraded tool enables researchers to set informed enrollment targets for specific demographic subgroups, supporting more inclusive and representative clinical trials across different patient populations. - Through partnership with the American Academy of Ophthalmology IRIS® Registry, the platform provides access to data from 15,000 contributing clinicians, revolutionizing protocol optimization and site selection.
- Verana Health and Nanoscope Therapeutics have formed a strategic partnership to accelerate retinitis pigmentosa research by analyzing real-world data from over 70,000 de-identified patients. - The collaboration will utilize Verana Health's Qdata® Retinitis Pigmentosa dataset to support the development of MCO-010, Nanoscope's optogenetic gene therapy aimed at vision restoration. - Through access to the American Academy of Ophthalmology IRIS® Registry, the partnership will leverage advanced AI and machine learning to track clinical outcomes and disease progression in RP patients.
- Electronic health record (EHR) data is becoming increasingly valuable for generating real-world evidence (RWE) in therapy development, offering clinical context that claims data cannot provide. - Artificial intelligence and machine learning are essential for processing large volumes of EHR data, with rigorous quality control processes needed to prevent biases and ensure accuracy. - A recent ophthalmology study using faricimab for neovascular age-related macular degeneration demonstrated how curated RWD can reveal treatment patterns and reduce injection frequency in real-world settings. - The combination of structured and unstructured EHR data with advanced AI tools is positioning real-world evidence as a complement to traditional clinical trial data in regulatory decision-making.
- Phase 2 trial data suggests ONL1204 ophthalmic solution may offer visual acuity benefits for patients with macula-off rhegmatogenous retinal detachment (RRD). - The study found a 1-2 line improvement in visual acuity at Week 24 in a subgroup with macula-off status of 8 days or more, compared to sham. - ONL1204 inhibits the Fas receptor, potentially preventing retinal cell death and vision loss associated with RRD. - Further analysis and discussions with the FDA are planned to advance the development of ONL1204.
- The FARETINA-DME study examined the real-world use of faricimab in over 7,700 eyes with diabetic macular edema (DME) using the American Academy of Ophthalmology's IRIS Registry. - Results showed a reduction in the number of injections needed after switching to faricimab, with treatment-naive eyes averaging 3.5 injections in the first 6 months and 2 in the second. - Both treatment-naive and previously treated eyes experienced an average improvement of 30 microns in mean central subfield thickness (CST) after switching to faricimab. - Treatment-naive eyes gained approximately four letters in visual acuity, while previously treated eyes maintained their vision, indicating faricimab's potential for extended therapy duration.
