The drug-device combination products industry is rapidly evolving, with a focus on integrating advanced technologies to enhance drug delivery and patient outcomes. Wearable injectors, such as YpsoMate by Ypsomed, are being developed for chronic conditions, enabling patients to administer biologics over extended periods. Smart inhalers, like those from Propeller Health, are gaining traction for respiratory conditions, providing real-time usage data to optimize treatment.
Insulin delivery systems continue to innovate, with products like NovoPen 6 offering digital connectivity for precise dosing and Omnipod providing a tubeless, wearable insulin pump. In cardiovascular care, drug-eluting stents, such as Boston Scientific's SYNERGY, combine mechanical support with localized drug release to prevent restenosis.
Implantable drug delivery systems, such as Probuphine for opioid dependence, offer long-term medication release, reducing the need for frequent dosing. Transdermal patches, like Neupro for Parkinson’s disease, deliver continuous medication through the skin, while pre-filled syringes and autoinjectors, such as Xolair and EpiPen, allow for convenient self-administration.
These innovations demonstrate the industry's commitment to developing combination products that offer personalized, convenient, and effective treatment options, addressing a wide range of therapeutic needs.
1. In July 2024, Oculis' OCS-01 eye drop, currently in the second stage of a Phase 3 trial for diabetic macular edema (DME), represents a significant advancement in the drug-device combination products industry, particularly in ophthalmology. DME is a leading cause of vision loss in diabetic patients, traditionally managed with invasive treatments like intravitreal injections. OCS-01 offers a non-invasive alternative, potentially transforming the standard of care for DME.
As a topical formulation, OCS-01 is designed to deliver high drug concentrations directly to the retina, bypassing the need for injections and improving patient compliance. The success of this product in the pipeline could lead to broader applications for other retinal conditions, highlighting the shift towards more patient-friendly drug delivery systems in ophthalmology.
This development is particularly important given the growing prevalence of diabetes and associated complications. If successful, OCS-01 could reduce the treatment burden on patients and healthcare providers by offering an easier, safer, and equally effective alternative to current invasive procedures. This eye drop exemplifies the potential of drug-device combination products to enhance therapeutic outcomes while improving the patient experience, positioning it as a crucial innovation in the pipeline of ophthalmic treatments.
2. In March 2024, Exonate's first-in-class eye drop, currently in Phase Ib/IIa trials, marks a significant development in the drug-device combination products industry, particularly for treating diabetic retinopathy (DR) and diabetic macular edema (DME). These conditions are essential causes of vision loss in diabetic patients, traditionally treated with invasive intravitreal injections. Exonate's eye drops offer a non-invasive alternative, which could drastically change the treatment landscape for these diseases.
The Phase Ib/IIa trial data has demonstrated both safety and biological activity, indicating that the eye drop not only avoids the complications associated with injections but also effectively targets the underlying causes of DR and DME. This product exemplifies the industry's move towards more patient-friendly drug delivery methods, which can improve patient adherence and outcomes.
If successful, Exonate's eye drop could become a game-changer in ophthalmology, providing a safer and more convenient option for patients. This innovation underscores the potential of drug-device combinations to enhance treatment efficacy while minimizing patient burden, highlighting the ongoing shift towards non-invasive therapies in the pipeline. This product's progress through clinical trials represents a critical step forward in developing new standards of care for retinal diseases.
3. In January 2023, the Cyrano trial, focused on developing a nasal spray therapy for hyposmia (reduced sense of smell), is a significant advancement in the drug-device combination products industry. Hyposmia, often associated with conditions like COVID-19, neurodegenerative diseases, and aging, has limited treatment options. The Cyrano trial is testing a novel intranasal therapy designed to directly target the olfactory system, offering a non-invasive and potentially effective treatment for this condition.
This nasal spray therapy is particularly important as it addresses a growing need for innovative solutions in treating sensory disorders. The ease of use and non-invasive nature of a nasal spray make it an attractive option for patients, potentially improving adherence and outcomes compared to more invasive procedures.
The success of this trial could lead to broader applications for nasal drug delivery systems in treating other neurological and sensory conditions, highlighting the versatility and potential of drug-device combination products. As the industry continues to evolve, therapies like the one being tested in the Cyrano trial demonstrate the increasing focus on patient-friendly, effective treatment options that can be easily integrated into everyday life, positioning this product as a key innovation in the drug-device pipeline.
4. The Chiesi Group has initiated a Phase III clinical trial for its Carbon Minimal Inhaler, a significant advancement in the drug-device combination products industry. This innovative inhaler is designed to be more environmentally friendly, addressing growing concerns about the carbon footprint of medical devices. The trial aims to evaluate the inhaler’s effectiveness and safety in delivering respiratory medications while minimizing environmental impact.
The Carbon Minimal Inhaler incorporates advanced design elements to reduce its carbon footprint, aligning with Chiesi's commitment to sustainability. This trial is pivotal as it represents a shift towards integrating environmental considerations into the development of drug delivery systems. By focusing on reducing greenhouse gas emissions associated with inhalers, the Carbon Minimal Inhaler could set a new standard for eco-friendly medical devices.
The successful outcome of this trial could not only enhance patient care by providing an effective treatment option but also contribute significantly to the broader movement of sustainable healthcare practices. This development highlights the industry's evolving focus on combining therapeutic efficacy with environmental responsibility, showcasing how drug-device combination products can address both patient needs and global sustainability goals.
5. In March 2024, Entod Pharma's development of the world's first human insulin eye drops represents a groundbreaking advancement in the drug-device combination products industry. Traditionally, insulin is associated with diabetes management, but this innovative approach explores its potential in treating eye diseases, such as diabetic retinopathy and dry eye syndrome. The eye drops aim to harness the healing properties of insulin directly in the eye, offering a non-invasive and targeted treatment option.
This development is particularly significant as it addresses a critical need for alternative treatments in ophthalmology. Current treatments for conditions like diabetic retinopathy often involve invasive procedures, such as intravitreal injections, which can be uncomfortable and carry risks. The insulin eye drops could provide a safer, more convenient option for patients, potentially improving treatment adherence and outcomes.
This innovation underscores the expanding role of drug-device combinations in offering novel therapeutic solutions. By integrating a well-known drug like insulin into a new delivery method, Entod Pharma is paving the way for more versatile applications of existing medications. This product is a key example of how the industry is evolving to meet the needs of patients with more effective, less invasive treatments, potentially transforming care in ophthalmology.
Serial No. |
NCT Number |
Title |
Condition |
Treatment |
Study Start Date |
Study Completion Date |
Sponsor/ Collaborator |
1. |
NCT05932225 |
Systane Complete Preservative Free Lubricant Eye Drops |
Dry Eye |
Other: Propylene glycol solution/drops |
August 18, 2023 |
March 2024 (estimated) |
Alcon Research |
2. |
NCT05911503 |
A Clinical Study of High Concentration (2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis |
Cytomegalovirus Retinitis Ganciclovir Eye Drops |
Drug: 2% Ganciclovir Eye Drops |
July 01, 2023 |
June 30, 2027 (estimated) |
Tianjin Medical University |
3. |
NCT05720715 |
Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial |
Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis |
Drug: cyclosporine A 0.05% eye drops |
January 01, 2022 |
March 2024 (estimated) |
Farwaniya Hospital |
4. |
NCT05910164 |
Single-center, Randomized, Crossover Clinical Study to Assess Patient Preference Between the Use of a Prefilled Syringe or a Prefilled Pen Device for Pegfilgrastim Administration (PELGRAZ) as Primary Prophylaxis of Chemotherapy-related Neutropenia |
Patient Preference Febrile Neutropenia, Drug-Induced Patient Satisfaction |
Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen |
June 09, 2023 |
October 09, 2024 (estimated) |
Institut Rafael |
5. |
NCT05720715 |
Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial |
Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis |
Drug: cyclosporine A 0.05% eye drops |
January 01, 2022 |
March, 2024 |
Farwaniya Hospital |
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