Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (2025)

Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (1)

Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (2)

Since 2014, WuXi AppTec DMPK has conducted ophthalmology research, gaining experience and expertise in preclinical ophthalmic drug development. We have mastered multiple routes of administration for the anterior and posterior segments of the eye, including eye drop instillation, intracameral injection, subconjunctival and retrobulbar injections,etc.

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  • Home
  • Therapeutic Areas
  • Ophthalmic
  • Overview

  • Study Model and Platform

  • Experience

  • Study Strategies and Assays

  • Instruments

  • Case Study

  • FAQs

  • Related Resources

  • Related Services

Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (7)

Therapeutic Areas

Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (8)

  • Ophthalmic

  • Central Nervous System (CNS)

  • Respiratory

  • Transdermal

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  • DMPK_Service@wuxiapptec.com

Overview

Compared to theother types of drug development, ophthalmic drug research exhibits characteristics of multiple biological barriers, significant analytical challenges, elaborate experimental operations, and lack of guidelines, posing challenges to R&D institutions.

Since 2014, WuXi AppTec DMPK has conducted ophthalmology research, gaining experience and expertise in preclinical ophthalmic drug development of small molecular and novelmolecular entities, including peptides, antibodies, oligos, etc. We have mastered multiple routes of administration for the anterior and posterior segments of the eye, including eye drop instillation, intracameral injection, subconjunctival and retrobulbar injections,etc. We demonstrate this expertise by performing high-quality dissection, precise sample processing, and bioanalysis of various ocular tissues. With comprehensive internal capabilities, we can collaborate with other teams within the WuXi AppTec platform to offer customers integrated R&D services.

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Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (12)

Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (13)

Study Model and Platform

  • In vitro platform

    WuXi AppTec DMPK Service has established high-throughput in vitro models for drug–melanin binding, and the ophthalmic permeability assays, including completed cornea and scleral permeability assays, which are fast, efficient, and cost-effective. These models facilitate a more precise understanding of the permeability, distribution, and accumulation of topical ophthalmic drugs, providing a valuable reference for relevant pharmacokinetics and pharmacological studies.

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (14)

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (15) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (16)

  • Ocular drug delivery

    The platform offers a wide range of ocular administration routes for various animal species (e.g., mice, rats, rabbits, dogs and monkeys), including eye drop, ointments or gel application, intracameral injection, subconjunctival injection, intravitreal injection, subretinal injection, pericular injection and retrobulbar injection.

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (17)

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (18) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (19)

  • Sample collection

    Type of
    sample
    Conjunct
    iva
    CorneaIrisCiliary
    body
    Crystalline
    len
    RetinaChoroidScleraVitreous
    humor
    Lacrimal
    gland
    Lower
    eyelid
    Optic nerveAqueous
    humor
    Tear

    Mouse

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    Rat

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    Rabbit

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    Dog

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    Monkey

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  • Ophthalmic sample processing

    Ocular tissues vary in size, structure, and characteristics, necessitating different processing methods. The platform provides different homogenization ratios and homogenization using different types of equipments, such as high-shear homogenizers, ball mills, and multifunctional biological sample homogenizers, and ensures the tissue homogenation is completed and uniformal.

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (90)

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (91) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (92)

  • Ophthalmic examination

    WuXi AppTec DMPK Service has professional veterinary team, comprehensive ophthalmic examination equipments, and well-established ocular scoring standards (Draize Eye Irritation scoring system and McDonald-Shadduck scoring system). These platforms provide various ophthalmic examinations, including intraocular pressure detection, pupillary reflex examination, slit lamp examination, fundus imaging, and sodium fluorescein staining.

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (93)

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (94) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (95)

  • Ocular sample analysis

    WuXi AppTec DMPK Service has extensive experience in the anlysis of ocular biological for both large and small molecular. Equipped with a wide range of highly sensitive and precise bioanalytical instruments, we analyzed over 5000 ocular samples annually, with a quantification limit as low as 5 pg/ml. We have innvovated unique methodologies to address challenges encountered in the bioanalysis of ocular samples, such as low drug concentrations in the systemic circulation, small sample volumes, difficulties in tissue homogenization, quantification of samples collected using special collection methods challenges in obtaining blank matrices, and the specific binding of drug to melanin. These methodologies ensure the provision of accurate and reliable analytical data.

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (96)

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (97) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (98)

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Experience

As part of radiolabeled ADME Network, WuXi AppTec DMPK offers a full range of14C & 3H custom radiolabeling services. With more than 10 years experiences, our team of synthetic radiochemists can preparevarieties of radiolabeled compounds, including small molecules, ADC, PDC, Proteolysis-Targeting Chimeras (PROTACs*), Peptide, etc.

  • 10+

    Years of experience

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (101) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (102)

  • 150+

    Ophthalmic projects

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (103) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (104)

Study Strategies and Assays

For ophthalmic drugs that function through systemic administration, the R&D strategy should focus on the tissue distribution of the compound in the ocular region, in addition to the reference to conventional systemic drug delivery studies.

For ophthalmic drugs that exert drug efficacy through ocular topical drug delivery: If a certain amount of the compound enters the systemic circulation after ocular topical administration, the R&D strategies should refer to the drugs into systemic administration. However, if no or minimal amount of compounds enters the systemic circulation after ocular topical administration, the research should focus on the distribution of the compound in ocular tissues.

In vitro melanin binding assays are useful for guiding the selection of animal species for ophthalmic drug studies and are recommended to be evaluated using the appropriate animal models in the early stages of preclinical development.

Research projectsOcular topical route of administrationSystemic route of administration

In vitro melanin binding assay

Required

On a case-by-case basis

In vitro plasma protein binding assay

Required if it enters the systemic circulation

Required

In vitro metabolic stability assay

In vitro drug-drug interaction assays

In vitro corneal/scleral permeation assay

Selection on a case-by-case basis

In vivo absorption

Species selection

Two species are recommended, large molecular selection of pharmacodynamically relevant species

Two species are recommended, large molecular selection of pharmacodynamically relevant species

Number of samples

3 samples/sex/time point

3 samples/sex/time point

Number of timepoints

≥ 5

Small molecules: 10–12; large molecules: 13–15

Route of administration

Ocular topical administration

IV, PO, SC, IM, etc.

Frequency of administration

Single or multiple

Single or multiple

In vivo distribution

Ocular tissue distribution required

Required

In vivo excretion

On a case-by-case basis

Required

In vivo metabolite identification

Instruments

WuXi AppTecDMPK is equipped with varioushigh-precision equipment and instruments, which canbe efficient andproducehigh-quality studyresults.

Case Study

    • Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (138) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (139)

      Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (140)

      Average tissue drug concentrations after a single intravitreal injection of commercialized vancomycin in New Zealand rabbits

      Figure 1

      Taking intravitreal injection of commercialized vancomycin in New Zealand rabbitsfor an example, after a single intravitreal injection of vancomycin at 1.00 mg/eye, aqueous humor, vitreous humor, sclera, iris, cornea, conjunctiva, retina, lens, and plasma were collected to evaluate the distribution of the drug in ocular tissues.

      To provide high-quality samples for bioanalysis, different homogenization ratios and homogenization devices were used. For example, cornea and sclera tissues are tough and not easily homogenized. If the homogenization ratio is inappropriate, the samples may become gelatinous and difficult to handle. After optimizing the homogenization ratio, a multi-functional biological sample homogenizer with three-dimensional high-speed vibration capabilities is used for sample processing, providing uniformly textured and well-flowing tissue homogenates.

      Bioanalysis: Due to various physiological mechanisms and barriers, extremely low drug concentrations is suspected in some ocular tissues, which places a high demand for the sensitivity of bioanalysis. Through the development and validation of analytical methods for various tissues, we have achieved a lower limit of quantification (LLOQ) of 0.1 ng/mL, enabling effective analysis of tissue samples.

      The results show that the drug concentration in plasma was extremely low (Cmax at 60.2 ng/mL). The drug mainly distributed in the vitreous , which is consistent with the pharmacokinetic characteristics of conventional intravitreal injection formulations. The study provides data support for the use of intravitreal injection as a route of administration for this drug.

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      Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (141)

    • Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (142) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (143)

      Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (144)

      Sirius T3

      Figure 1

      The bland-Altman plot of fu by flux dialysis and literature-reported data, which is used to determine whether the two test methods agree. The upper and lower dashed lines are the upper and lower limit of the 95% confidence interval for the difference. The upper and lower dotted lines are the upper and lower limit of the 95% confidence interval for the mean difference. The test data is considered reliable if the mean difference 95% confidence interval encompasses zero.

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      Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (145)

FAQs

  • Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (146)

    What are ophthalmic drugs?

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (147) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (148)

    Ophthalmic drugs are medications that are used to treat various ocular diseases and visual impairments, including, refractive errors, cataracts, age-related macular degeneration (AMD), glaucoma, diabetic retinopathy (DR), corneal opacity, trachoma, dry eye syndrome, and conjunctivitis, etc.These drugs can be in the formsof eye drops, gels, or other medications specifically designed for ophthalmic use.

  • Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (149)

    What are some common DMPK challenges of ophthalmic drug delivery?

    Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (150) Ophthalmic Drugs DMPK Services - WuXi AppTec DMPK Service (151)

    The biggest challenge in ocular drug delivery research is overcoming static and dynamic biological barriers to effectively deliver the drug to target ocular tissues. These barriers can be classified based on their anatomical location and functional characteristics, which are generally categorized as anterior segment barriers and posterior segment barriers. Anterior segment barriers include static barriers,such as the cornea, conjunctiva, blood-aqueous barrier, and efflux pumps, as well as dynamic barriers, including tear drainage, and the aqueous humor. Posterior segment barriers include static barriers, such as the sclera, Bruch membrane, blood-retinal barrier, and dynamic barriers, such as the choroidal blood, etc.

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