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Protheragen is a leading full-service solutions provider in the field of ophthalmic disease drug and therapy development. We are dedicated to advancing the frontier of innovative therapeutics for ophthalmic diseases. Our comprehensive service portfolio encompasses meticulous preclinical research and the development of sophisticated disease models, offering a seamless and integrated support system for your projects at every stage. Furthermore, our extensive and diverse collection of human specimens, carefully sourced from both healthy volunteers and patients, serves as a powerful catalyst, significantly accelerating your drug and therapy development efforts in this highly specialized and demanding field of ophthalmic diseases.
Fig.1 Summary of tear capacities for detection of various biomarkers in ocular diseases (top) and ocular complication disease fluorescent sensing (bottom). (Shi, Y., et al., 2022)
Ophthalmic diseases encompass a wide variety of illnesses pertaining to the eyes and their adjacent tissues, which may culminate in visual impairment or other associated complications. These disorders can be classified into anterior segment diseases, which include refractive errors, cataracts, and surface ocular diseases; and posterior segment diseases, which comprise retinal disorders such as age-related macular degeneration, diabetic retinopathy, and glaucoma. Diagnosis usually involves a thorough clinical assessment of the eyes using sophisticated imaging modalities, while therapy includes pharmacological therapies with lifestyle changes, surgery, and interventions. Developing effective therapeutics requires grasping the underlying pathogenic processes and determining strategic therapeutic targets—focal points like inflammatory pathways, protective mechanisms against damaging stimuli on the nervous system, factors promoting blood vessel growth, and oncogenes, as well as molecular pathways.
Many ophthalmic diseases have a genetic component. For instance, mutations in specific genes can lead to inherited retinal disorders such as retinitis pigmentosa. These genetic mutations disrupt normal cellular function and lead to degeneration of retinal cells.
Environmental factors such as exposure to ultraviolet light, smoking, and poor nutrition can exacerbate the risk of developing ophthalmic diseases. For example, prolonged exposure to UV light is associated with an increased risk of cataract formation.
Autoimmune reactions can target ocular tissues, leading to conditions like uveitis. In these cases, the immune system mistakenly attacks the eye's own cells, causing inflammation and damage.
Age-related changes and oxidative stress can lead to the degeneration of ocular tissues. This is particularly evident in age-related macular degeneration, where the macula deteriorates over time, leading to central vision loss.
The development of effective therapeutics for ophthalmic diseases necessitates a profound comprehension of the underlying pathophysiological mechanisms and the pinpointing of key targets for intervention. Below are some of the primary targets in ophthalmic disease therapeutics:
Inflammation is a crucial factor in many ophthalmic diseases, such as uveitis, scleritis, and certain forms of glaucoma. By targeting inflammatory pathways, including the NF-κB signaling pathway and the production of pro-inflammatory cytokines, it is possible to reduce inflammation and prevent tissue damage.
Preserving the integrity of retinal neurons and the optic nerve is of utmost importance in conditions like glaucoma and age-related macular degeneration (AMD). Therapeutics that enhance neuroprotective mechanisms, such as activating the retinal pigment epithelium and promoting retinal ganglion cell survival, can play a vital role in preserving vision.
In diseases like diabetic retinopathy and wet AMD, abnormal blood vessel growth (neovascularization) is a major cause of vision loss. Targeting angiogenic factors, particularly vascular endothelial growth factor (VEGF), can effectively inhibit neovascularization and mitigate the risk of complications.
The progress in genetic research has enabled the identification of specific genes and molecular pathways associated with a variety of ophthalmic diseases. As a result, targeted therapies, including gene therapy and small molecule inhibitors, are being developed to address these genetic and molecular targets, thereby offering more personalized therapeutic options.
The field of development therapies for ophthalmic diseases has seen significant advancements in recent years. Current therapeutic approaches include pharmacological interventions, surgical procedures, gene therapy, and cellular therapy. Gene therapy and cellular therapy are emerging fields with promising results in clinical trials. However, challenges remain in delivering therapies to the eye and achieving long-term efficacy.
Table 1. Current clinical trials and FDA-approved ocular therapies. (Whalen M., et al., 2024)
| Disease | Delivery System | Delivery Location | Clinical Trial Number | FDA-Approved Therapy |
| Achromatopsia | AAV | Subretinal | NCT03278873, NCT02935517, NCT02599922 | None |
| Dry AMD | Retinal prosthesis, Stem cells | Subretinal, Intravitreal | NCT03392324, NCT01736059, NCT04339764, NCT04627428, NCT05187104 | None |
| Wet AMD | Lentivirus, Monoclonal antibody, AAV, Axitinib suspension, Axitinib implant, Durasert, Soluble protein decoy, Brachytherapy | Subretinal, Intravitreal, Suprachoroidal, Episcleral | NCT01678872, NCT04777201, NCT04832724, NCT05891548, NCT04989699, NCT05381948, NCT04423718, NCT05112861, NCT02988895 | Aflibercept (Eylea), a VEGF inhibitor, for intravitreal injection. Faricimab (Vabysmo), a VEGF and Ang-2 inhibitor, for intravitreal injection. Ranibizumab (Lucentis, Byooviz), a VEGF inhibitor, for intravitreal injection. Brolucizumab (Beovu), a VEGF inhibitor, for intravitreal injection. |
| Geographic Atrophy Secondary to AMD | Pegcetacoplan (APL-2) C3 inhibitor, Antisense Inhibitor of Complement Factor B, AAV | Intravitreal, Subcutaneous, Subretinal | NCT04770545, NCT03815825, NCT04656561, NCT06018558 | Pegcetacoplan (Syfovre), a C3 inhibitor, for intravitreal injection. Avacincaptad pegol (Izervay), C5 inhibitor, for intravitreal injection. |
| Choroideremia | AAV | Intravitreal | NCT04483440 | None |
| Diabetic Macular Edema | Triamcinolone acetonide, Ranibizumab, Anti-IL6 monoclonal antibody, Dexamethasone, Bevacizumab, Drug implant, aflibercept | Suprachoroidal, Intravitreal, Eye drops | NCT05512962, NCT05151744, NCT05066997, NCT05112861, NCT04469595, NCT04411693, NCT04108156, NCT04429503 | Ozurdex biodegradable implant for sustained dexamethasone release. Faricimab (Vabysmo), a VEGF and Ang-2 inhibitor, for intravitreal injection. Ranibizumab (Lucentis, Byooviz), a VEGF inhibitor, for intravitreal injection. Aflibercept (Eylea), a VEGF inhibitor, for intravitreal injection. Brolucizumab (Beovu), a VEGF inhibitor, for intravitreal injection. |
| Diabetic Retinopathy | Stem cells, Selective integrin inhibitor, Ranibizumab implant, Aflibercept, Brolucizumab | Intravitreal, Eye drops | NCT01736059, NCT05409235, NCT04503551, NCT04708145, NCT04278417 | Aflibercept (Eylea), a VEGF inhibitor, for intravitreal injection. Ranibizumab (Lucentis, Byooviz), a VEGF inhibitor, for intravitreal injection. |
| Dry Eye Disease | Lipid conjugated chemerin peptide agonist, small molecule, siRNA, rhNGF, TRPM8 agonist, synthetic peptide, Thermomechanical system | Eye drops, Peri-orbital | NCT05759208, NCT05403827, NCT05310422, NCT05133180, NCT05493111, NCT05136170, NCT05467293, NCT05162261, NCT04795752 | Miebo, Restasis, a cyclosporin drug, and Eysuvis, an ophthalmic suspension with loteprednol etabonate as eye drops. |
| Leber Congenital Amaurosis | AAV, RNA antisense oligonucleotide, CRISPR/Cas9 | Subretinal, Intravitreal | NCT01208389, NCT03920007, NCT00481546, NCT00999609, NCT03913143, NCT03872479 | AAV2-RPE65 (Luxturna) for subretinal injection gene replacement therapy. |
| Leber Hereditary Optic Neuropathy | AAV | Intravitreal | NCT02161380, NCT03293524 | None |
| X-linked RP | AAV | Intravitreal | NCT04517149 | AAV2-RPE65 (Luxturna) for subretinal injection gene replacement therapy. |
| X-linked Retinoschisis | AAV | Intravitreal | NCT02317887 | None |
| Usher Syndrome | Lentivirus, RNA Antisense oligonucleotide | Intravitreal, Subretinal | NCT05158296, NCT02065011 | None |
| Stargardt Disease | Equine infectious anemia virus, AAV, complement factor C5 inhibitor | Subretinal, Intravitreal | NCT01736592, NCT03364153, NCT05956626 | None |
Disclaimer: Protheragen focuses on providing preclinical research services. This table is for information exchange purposes only. This table is not a treatment plan recommendation. For guidance on treatment options, please visit a regular hospital.
At Protheragen, we offer a comprehensive suite of diversified disease solutions tailored to address the complexities of ophthalmic diseases. Our services integrate advanced technologies and scientific expertise to develop targeted diagnostics and therapeutics. By leveraging cutting-edge research and innovative methodologies, we aim to provide effective solutions for a wide range of ophthalmic conditions, from common disorders to rare genetic diseases.
Protheragen specializes in the development of diagnostic tools for ophthalmic diseases. Our diagnostic development services focus on creating accurate and reliable methods to detect and monitor ophthalmic conditions. Utilizing advanced imaging techniques, biomarker identification, and molecular diagnostics.
By combining our expertise in pharmacology, genetics, and cell biology, we strive to develop effective therapies that address the underlying causes of ophthalmic disorders. Our commitment to scientific excellence ensures that our therapeutic solutions are grounded in rigorous research and validated through robust testing.
By Therapeutic Strategies
Preclinical research is a cornerstone of our services at Protheragen. Our preclinical research services encompass a wide range of activities, from in vitro studies to in vivo animal models. We conduct comprehensive evaluations of potential therapeutic candidates, assessing their efficacy, safety, and pharmacokinetics. By utilizing state-of-the-art facilities and expert scientific teams, we ensure that our preclinical research is of the highest quality. Our goal is to provide robust data that supports the advancement of promising therapies into clinical trials.
Drug Safety Evaluation Services
Pharmacokinetics Study Services
Protheragen offers a comprehensive portfolio of biospecimens and ocular cell products related to human ophthalmic diseases. With an extensive network of collection sites, we ensure diverse sample acquisition while maintaining strict ethical standards. Additionally, we provide customized solutions to cater to the specific research requirements of our clients.
How does Protheragen ensure the relevance of preclinical cancer models to human ophthalmic cancers?
Protheragen utilizes advanced genetic engineering and organoid technologies to create cancer models that closely mimic human ocular tumors. Our models are validated through rigorous testing to ensure they accurately reflect tumor biology and drug response, providing reliable data for preclinical cancer therapy research.
What specific preclinical services does Protheragen offer for ophthalmic cancer therapy development?
Protheragen provides comprehensive preclinical services including cancer model development, efficacy and safety testing, and pharmacokinetic studies tailored for ophthalmic cancers. Our services are designed to support the early stages of cancer therapy research, ensuring robust data for subsequent clinical development.
How does Protheragen support clients in optimizing drug delivery for ophthalmic cancer therapies?
Protheragen specializes in preclinical research to optimize drug delivery systems for ophthalmic cancer therapies. We offer solutions such as targeted formulations and delivery mechanisms to enhance drug efficacy and minimize side effects, supporting clients in overcoming challenges in ocular drug delivery.
How does Protheragen ensure the ethical and regulatory compliance of its preclinical cancer research services?
Protheragen adheres to strict ethical guidelines and regulatory standards in all preclinical cancer research. Our services are designed to ensure that all studies are conducted with the highest level of integrity, providing reliable and compliant data for future clinical applications.
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