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Project Description

Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Drug Safety Evaluation Services

The evaluation of drug safety for ophthalmic diseases is a pivotal component in the developmental journey of new therapeutic agents, ensuring their progression is grounded in responsibility and evidence. As a leading provider of research services, Protheragen offers expert ophthalmic drug safety evaluation services to support pharmaceutical companies worldwide in the successful completion of therapy development programs.

Introduction to Drug Safety Evaluation

The assessment of drug safety for ophthalmic diseases plays a crucial role in the development of novel drugs aimed at treating a variety of eye conditions. Scientifically, this process involves a series of preclinical studies crafted to evaluate the safety, toxicity, and potential side effects of drugs before human administration. These evaluations encompass a wide array of tests, including ocular distribution, general toxicology, ocular toxicology, and genetic toxicology studies. Such assessments are vital to ensure that the drugs being developed do not provoke adverse reactions in ocular tissues and to gain a comprehensive understanding of their pharmacological profile.

Incidence of adverse events (AE) of ophthalmic drugs.

Fig.1 Incidence of adverse events (AE) in 166 NHV for approved ophthalmic disease drugs (AD, upper polar graphs) and investigational ophthalmic disease drugs (ID, lower polar graphs). (Muñoz-Villegas P., et al., 2021)

Drug Safety Evaluation in Ophthalmic Diseases

The field of ophthalmic diseases drug safety evaluation has witnessed remarkable progress in recent years, driven by the rapid advancement of novel therapeutic approaches and delivery technologies. As the understanding of ocular pathophysiology and the mechanisms underlying various eye conditions has deepened, researchers and regulatory agencies have collaborated to establish more robust and comprehensive evaluation frameworks.

One notable development is the growing recognition of the importance of evaluating not just the active pharmaceutical ingredient, but also the entire drug delivery system and its potential impact on ocular tissues. This holistic approach has led to the emergence of innovative formulations, such as nanoparticles, microparticles, and ocular implants, which offer enhanced drug targeting, sustained release, and improved patient compliance.

Moreover, the increased availability of advanced in vitro and in vivo models, coupled with the refinement of regulatory guidelines, has enabled more precise and predictive assessments of ocular drug safety. These advancements have been crucial in addressing the unique challenges posed by the eye's anatomical and physiological characteristics, ultimately facilitating the development of safer and more effective ophthalmic therapies.

Our Services

At Protheragen, we are committed to providing comprehensive and cutting-edge ophthalmic diseases drug safety evaluation services to support the development of innovative ocular therapies. Our team of seasoned scientists, toxicologists, and pathologists brings a wealth of expertise and a deep understanding of the complexities inherent in evaluating the safety of ophthalmic drug candidates.

Ocular Distribution Study Service

Ocular distribution studies are designed to understand how a drug is absorbed, distributed, and eliminated within the eye. Protheragen employs state-of-the-art techniques such as liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantify drug levels in various ocular tissues and fluids, including the cornea, aqueous humor, and retina.

General Toxicology Study Service

General toxicology studies assess the systemic effects of ophthalmic drugs. Protheragen utilizes a range of animal models to evaluate the potential for organ toxicity, hematological changes, and histopathological alterations. Our rigorous approach ensures the safety of our medicines, thereby reducing the potential risks of our therapies.

Ocular Toxicology Study Service

Ocular toxicology studies focus on the local effects of drugs on the eye. Protheragen specializes in evaluating the potential for ocular irritation, inflammation, and damage using a variety of techniques, including slit-lamp biomicroscopy, indirect ophthalmoscopy, and electroretinography (ERG).

Genetic Toxicology Study Service

Genetic toxicology studies are essential to assess the potential of a drug to cause genetic mutations or chromosomal aberrations. Protheragen offers a comprehensive battery of in vitro and in vivo tests, including the Ames test, micronucleus test, and comet assay. These studies play a critical role in identifying potential carcinogenic risks associated with long-term drug use.

We tailor our services to meet the specific needs of each project, ensuring that the evaluation is aligned with the unique characteristics of the drug and the target ocular condition. If you are interested in our services, please feel free to contact us for more details and quotation information of related services.

Reference

Muñoz-Villegas Patricia, et al. "Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials." Therapeutics and Clinical Risk Management (2021): 1123-1134.