A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%

The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)

Start Date22 Apr 2024

Sponsor / Collaborator

Novaliq GmbH

NCT04523142 / CompletedPhase 3

A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Start Date04 Jan 2021

Sponsor / Collaborator

Novaliq GmbH

NCT04523129 / CompletedPhase 3

A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Start Date05 Dec 2020

Sponsor / Collaborator

Novaliq GmbH

100 Clinical Results associated with Novaliq GmbH

0 Patents (Medical) associated with Novaliq GmbH

Literatures (Medical) associated with Novaliq GmbH

01 Jun 2024·Die Ophthalmologie

Article

Author: Sahel, José-Alain ; Marshall, John ; Lagrèze, Wolf ; Roesky, Christian ; Sieving, Paul ; Gliem, Martin ; Cursiefen, Claus ; Ader, Marius ; Helbig, Horst ; Schlötzer-Schrehard, Ursula ; Fauser, Sascha ; Ueffing, Marius

01 Apr 2024·JAMA ophthalmology

Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease

Article

Author: Yan, Xiaoming ; Gu, Hao ; Zhong, Xingwu ; Hong, Jing ; Li, Gang ; Jie, Ying ; Wu, Huping ; Zhang, Kaiyun ; Zhao, Shaozhen ; Peng, Rongmei ; Long, Qin ; Xu, Ruxia ; Gong, Lan ; Krösser, Sonja ; Zhu, Lei

Importance:

Dry eye disease (DED) is a prevalent eye disorder. Cyclosporine is an effective immunomodulator that is widely used in DED; however, due to its highly hydrophobic nature, delivery of cyclosporine to the ocular surface is challenging.

Objective:

To evaluate the efficacy and safety of SHR8028, a water-free cyclosporine ophthalmic solution, 0.1%, compared with vehicle in Chinese participants with DED.

Design, Setting, and Participants:

This was a multicenter, double-blind, vehicle-controlled, phase 3 randomized clinical trial conducted from March 4, 2021, to July 22, 2022. Adult participants with moderate to severe DED were recruited from 12 hospitals in China. Study data were analyzed April 2, 2022, for the primary analysis.

Interventions:

Following a 14-day run-in period with an artificial tear, participants were randomly assigned (1:1) to receive water-free cyclosporine or vehicle (1 eye drop in each eye twice daily). After a 29-day treatment, participants of both groups were given the option to receive water-free cyclosporine for an additional 12 weeks for longer-term safety assessment.

Main Outcomes and Measures:

The primary end points were changes from baseline in total corneal fluorescein staining (tCFS) using the National Eye Institute scale and in dryness score on a visual analog scale at day 29.

Results:

A total of 206 participants (mean [SD] age, 47.8 [14.2] years; 185 female [90%]) were enrolled, with 103 each in the cyclosporine group and the vehicle group. At day 29, the cyclosporine group experienced improved tCFS compared with vehicle (change [Δ] = −1.8; 95% CI, −2.7 to −1.0; P &lt; .001), with a tCFS score decrease from baseline of −4.8 in the cyclosporine group and −3.0 in the vehicle group. Dryness score decreased from baseline in both groups (−19.2 vs −15.4; Δ = −3.8; 95% CI, −9.2 to 1.6; P = .17). During the 29-day treatment, treatment-related adverse events were reported in 15 participants (14.6%) in the cyclosporine group and 11 participants (10.7%) in the vehicle group.

Conclusions And Relevance:

Results demonstrated superiority of a water-free cyclosporine, 0.1%, eye solution over vehicle in improving tCFS score at day 29 in Chinese participants with DED. However, dryness score (VAS) was not improved at day 29.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05841043

01 Aug 2023·European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

Topical ocular protein delivery based on protein powder suspensions in semifluorinated alkanes.

Article

Author: Marschall, Christoph ; Hauptmeier, Bernhard ; Witt, Madlen ; Filster, Julia ; Frieß, Wolfgang

The field of ocular diseases, specifically retinal diseases is a successful target area for protein drugs with various marketed products. Besides the intraocular treatment of the retina, the topical treatment of corneal or conjunctival diseases is a promising approach. Topical ocular protein formulations face the challenges of poor penetration and potentially low stability. In this study we tested suspensions based on the semifluorinated alkane F6H8 to improve the topical ocular protein delivery. Such suspensions are well known for the increased protein stability compared to aqueous solutions. Furthermore, F6H8 is well known as vehicle for ocular delivery due to its easy spreading on the cornea. Penetration of a model mAb and its Fab fragment was tested in an ex vivo corneal penetration test. The amount of penetrated protein was increased when the protein powder suspensions were used compared to the respective aqueous solutions. Sodium caprate as penetration enhancer at 5 mg/ml substantially increased the Fab fragment (7-fold) and the mAB (3-fold) concentration in the corneal tissue when applied as an aqueous solution. The effect was surprisingly more pronounced, when Fab fragment (31-fold) or mAb (13-fold) and the penetration enhancer were formulated as F6H8 suspensions. The same penetration enhancement from suspensions could be achieved with 2.5 mg/ml, but the penetration was reduced compared to 2.5 mg/ml in the aqueous solution. A test based on stratified human keratinocytes did not indicate eye irritation by the tested formulations. Furthermore, stability studies for bevacizumab suspensions in semifluorinated alkanes were investigated and showed superior long-term stability compared to the marketed aqueous solution. Overall results demonstrate the high potential of topical ocular protein delivery using powder suspensions in non-aqueous vehicles based on semifluorinated alkanes.

News (Medical) associated with Novaliq GmbH

26 Jul 2024

·www.fiercepharma.com

Europe's CHMP endorses clutch of new medicines including Astellas, J&J and Ipsen offerings

After the Committee for Medicinal Products for Human Use issues recommendations on new medicines, the European Commission must grant final approvals. While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions.In a busy meeting this week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) signed off on seven new medicines, six biosimilars and 11 label expansions for existing drugs. In addition, Accord's generic to Pfizer's tyrosine kinase inhibitor Inlyta gained a CHMP thumbs-up, according to CHMP's meeting summary.Perhaps most notably, European regulators this week turned away Eisai and Biogen's Alzheimer's disease filing for Leqembi.Conversely, Astellas' Vyloy (zolbetuximab) to treat gastric or gastro-oesophageal junction adenocarcinoma appears to be heading toward an EU approval. That drug suffered an FDA rejection early this year and is on track for a new approval decision in the U.S. by Nov. 9.In addition, J&J's single-tablet combination of macitentan and tadalafil scored a CHMP endorsement for patients with pulmonary arterial hypertension. The drug combination scored FDA approval in March and is branded as Opsynvi in the U.S.Besides those meds, new offerings from LEO Pharma, Ipsen, Novaliq and other companies made the grade at CHMP this week. LEO's Anzupgo snared an approval recommendation in chronic hand eczema, while TMC Pharma's June Biosciences-partnered cancer medicine Loqtorzi secured its own thumbs-up. Ipsen, for its part, nabbed endorsements for two rare liver disease medicines: Iqirvo in primary biliary cholangitis and Kayfanda in Alagille syndrome.As for existing meds, CHMP regulators signed off on the key first-line bladder cancer use for the combination of Merck's Keytruda and Pfizer and Astellas' Padcev, as well as for Roche's Tecentriq as a monotherapy in first-line non-small cell lung cancer in patients who are ineligible for platinum-based therapy, plus a host of other drugs.Further, new biosimilars to Johnson & Johnson's Stelara, plus Roche's trio of Rituxan, Lucentis and Herceptin are heading to the European Commission (EC) with CHMP support.After the CHMP meeting, all the recommendations now head to the EC for a final decision on approval.

Drug ApprovalAccelerated Approval

06 Mar 2024

·www.businesswire.com

Global Anterior Uveitis (Iritis) Drug Pipeline Research Report 2024 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Anterior Uveitis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anterior Uveitis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anterior Uveitis pipeline landscape is provided which includes the disease overview and Anterior Uveitis treatment guidelines. The assessment part of the report embraces, in depth Anterior Uveitis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anterior Uveitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Anterior Uveitis R&D. The therapies under development are focused on novel approaches to treat/improve Anterior Uveitis Anterior Uveitis Emerging Drugs Chapters This segment of the Anterior Uveitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Anterior Uveitis Emerging Drugs TRS01: Tarsier Pharma Dazdotuftide (formerly known as TRS01) is a first-in-class drug with a new and unique mechanism of action, for the treatment of ocular blinding diseases of back- and front- of the eye. Dazdotuftide is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action. Dazdotuftide was found to modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2). Due to dazdotuftide's unique mechanism of action of immunomodulation, it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. Currently, the drug is Phase III stage of its clinical trial for the treatment of anterior uveitis. Anterior Uveitis Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anterior Uveitis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anterior Uveitis drugs. Anterior Uveitis Therapeutic Assessment Major Players in Anterior Uveitis There are approx. 3+ key companies which are developing the therapies for Anterior Uveitis. The companies which have their Anterior Uveitis drug candidates in the most advanced stage, i.e. Phase III include, Tarsier Pharma. Phases: The report covers around 3+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Anterior Uveitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Anterior Uveitis Report Insights Anterior Uveitis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Anterior Uveitis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Tarsier Pharma Oculis Pharma Novaliq Key Products TRS01 OCS 2 Tacrolimus For more information about this clinical trials report visit https://www.researchandmarkets.com/r/tkzvsx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Gene Therapy

24 Aug 2023

·www.pharmaceutical-technology.com

Novaliq pursues EMA approval for dry eye disease drug

Akosua Mireku @AkosuaMireku1 CyclASol is an eye drop solution for dry eye disease. Credit: Andrii Borodai via Getty Images. The European Medicines Agency (EMA) accepted Novaliq’s marketing authorisation application for CyclASol (cyclosporine ophthalmic solution) 0.1% as a treatment for dry eye disease (DED) . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the MAA, using the centralised procedure for all 27 member states of the European Union. Recommended Reports Reports LOA and PTSR Model - Progesterone in Keratoconjunctivitis Sicca (Dry Eye) GlobalData Reports LOA and PTSR Model - Timbetasin Acetate in Keratoconjunctivitis Sicca (Dry Eye) GlobalData View all Companies Intelligence Harrow Health Inc Novaliq GmbH MAA Co Ltd DED Limited C H M P INC View all In order to determine the drug’s approval chances, the CHMP will evaluate results from six clinical trials in CyclASol’s clinical development programme. This includes results from the Phase III ESSENCE-2 trial (NCT04523129) that showed that the eye drops had a good tolerability profile, with a clinically meaningful effect on 71.6% of participants in the cyclosporine group. Germany-headquartered Novaliq received regulatory approval for CyclASol from the US Food and Drug Administration (FDA) as a DED treatment on 30 May. Marketed under the US brand name, Vevye, the drug became the first and only cyclosporine solution approved for the condition with efficacy demonstrated after four weeks of treatment. In the US and Canada, Harrow Health holds the rights to commercialise the DED therapy, as per a July 2023 deal . CyclASol’s mechanism of action works through the binding of cyclosporine to cyclophilin. This complex suppresses a pathological immune response, which prevents ocular inflammation—a major cause of dry eye disease in many patients. The therapy uses Novaliq’s EyeSol technology to avoid the need for water-based excipients. The biotech lists the benefits of this approach as increasing the drug’s bioavailability and providing a longer residual time on the eye amongst other things. Novaliq’s pipeline currently consists of five DED products and seven candidates for other ophthalmologic conditions. The company is also pursuing research for dermatological treatments through a separate entity Dermaliq. The dermatology clinical programme is currently investigating three drug candidates for androgenetic alopecia, psoriasis, and bacterial skin infections, using its proprietary hyliQ drug delivery technology. In a press release , Novaliq’s CEO Christian Roesky said: “The acceptance of the EU marketing authorisation application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. “We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

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Pipeline

Pipeline Snapshot as of 28 Sep 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 2

NDA/BLA

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Cyclosporine ( CaN )	Xerophthalmia More	NDA/BLA
Timolol ( β-adrenoceptors )	DED More	Phase 2
BTQ 1901/BTQ 1902	Glaucoma More	Phase 2
Iodine	Conjunctivitis, Bacterial More	Preclinical
NQ-2020	Diabetic Retinopathy More	Preclinical

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Investment

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Financing

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