Delving into the Latest Updates on BDDE cross-linked sodium hyaluronate gel with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BDDE cross-linked hyaluronic acid, Butanediol diglycidyl ether cross-linked hyaluronic acid, Cross-linked hyaluronic acid

+ [9]

Target-

Action-

Mechanism-

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Osteoarthritis, KneeOsteoarthritis

Inactive Indication-

Originator Organization

LG Chem Ltd.

Active Organization

NovoTek Therapeutics, Inc.

LG Chem Ltd.

Inactive Organization

LG Life Sciences Ltd.

Drug Highest PhaseApproved

First Approval Date

South Korea (15 Oct 2013),

Osteoarthritis

Regulation-

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PURPOSERemoving transparent vitreous tissues, such as a residual vitreous cortex (VC) or proliferative membrane, without damaging the retina is often problematic in vitrectomy. We examined the feasibility of an injectable in situ cross-linking hyaluronan hydrogel (XL-HA) for vitrectomy.STUDY DESIGNExperiments using ex vivo and in vivo animal models.METHODSHA-dibenzocyclooctyne and HA-azidoethylamine solutions were mixed to form XL-HA, which then gradually formed a hydrogel. We tested the function of XL-HA in ex vivo porcine eyes. We then examined the performance of XL-HA in in vivo rabbit models of posterior vitreous detachment, posterior VC removal, and proliferative vitreoretinopathy.RESULTSThe ex vivo study showed that XL-HA rapidly embedded triamcinolone acetonide, mimicking VC attached to the retina, and became hard enough to be pinched with tweezers within 3 minutes, allowing us to remove only the triamcinolone acetonide without impairing the internal limiting membrane. In the in vivo rabbit models, XL-HA injection improved posterior vitreous detachment, and the thin and fragile posterior VC or fibrous proliferative membrane was readily peeled off without any damage to the underlying retina as compared with untreated controls. A short-term intraocular biocompatibility test demonstrated that the intraocular pressure remained normal with XL-HA injected into the eye. In addition, transmission electron microscopy showed no obvious abnormalities in the cornea or in the inner and outer retina.CONCLUSIONThe results indicate that XL-HA is a potential adjunctive device to help make vitrectomy safe, effective, and successful.

19 Apr 2023·Journal of clinical medicine

Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study.

Article

Author: Moster, Erik ; Pavelka, Karel ; Park, So La ; Blicharski, Tomasz ; Plebanski, Rafal ; Lukasik, Piotr ; Zegota, Zbigniew ; Szuscik, Marek ; Jeon, Seonhui

The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

01 Jan 2023·PloS one

Safety and effectiveness of intra-articular injection of a highly cross-linked hyaluronic acid, LBSA0103 (Synovian): Results from a post-marketing surveillance study in South Korea.

Article

Author: Ha, Jeong-Ku ; Shon, Oog Jin ; Ahn, Ji Hyun ; Kim, Kang-Il ; Park, Ki-Bong ; Kim, Jae Gyoon ; Han, Hyuk-Soo ; Seon, Jong-Keun ; Seo, Young-Jin ; Bae, Ji Hoon ; Choi, Eui Sung ; Moon, Sang Won ; Wang, Lih ; Wang, Joon-Ho ; Park, Yong-Geun

This study aimed to assess the safety and effectiveness of the highly cross-linked hyaluronic acid-LBSA0103-in patients with knee osteoarthritis (OA) as per the prescribing information (PI) in South Korea. A total of 3,140 subjects aged ≥19 years were enrolled in this post-marketing surveillance (PMS) study from 2013 to 2019. The subjects received one or two injections of LBSA0103. The median duration of follow-up was 308 days. Adverse events (AEs), adverse drug reactions (ADRs), and serious AEs (SAEs) were monitored. Effectiveness was evaluated based on an index of effectiveness in accordance with the guidelines established by the Ministry of Food and Drug Safety and using a 100-mm visual analog scale (VAS) for weight-bearing pain. Overall, 250 subjects (7.96%) experienced 292 AEs and of these, unexpected AEs occurred in 114 subjects (3.63% [95% CI: 3.00-4.35]). Injection site pain was the most frequent AE reported by 81 subjects (2.58% [95% confidence intervals (CI): 2.05-3.20]). One hundred subjects experienced 108 ADRs (3.18% [95% CI: 2.60, 3.86]) and 15 unexpected ADRs were experienced by 13 subjects (0.41% [95% CI: 0.22-0.71]). Seventeen subjects experienced 22 SAEs (0.54% [95% CI: 0.32-0.87]) during the entire PMS period, and all were considered "unlikely" related to the study drug. Most AEs were mild in terms of severity and resolved during the study period. LBSA0103 was also effective in relieving symptomatic pain in knee OA patients. The condition in more than 80% of the subjects was considered to be improved when assessed by the investigators. LBSA0103 resulted in a significant reduction in the mean VAS score at 12 weeks after the first and second injections (24.79 (± 20.55) mm and 17.63 (±12.31) mm, respectively; p<0.0001). In conclusion, LBSA0103, used for the treatment of knee OA in a real-world setting, was well tolerated, with an acceptable safety profile and consistent therapeutic effect.

100 Deals associated with BDDE cross-linked sodium hyaluronate gel

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	M09AX01	DB08818

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoarthritis, Knee	China	LG Chem Ltd.	28 Mar 2023
Osteoarthritis, Knee	China	NovoTek Therapeutics, Inc.	28 Mar 2023
Osteoarthritis	South Korea	LG Chem Ltd.	15 Oct 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Discovery	South Korea	LG Life Sciences Ltd.	01 Dec 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03561779 (Pubmed \| Clin Ther)	Phase 3	Osteoarthritis, Knee	184	YYD302	dulqpztwxj(cqyltqkmvg) = relnaognmw yxuekjtdhw (qubungnctp )	Positive	01 Nov 2021
				Synovian	dulqpztwxj(cqyltqkmvg) = tsabdnfpyw yxuekjtdhw (qubungnctp )
EULAR2004	Not Applicable	Osteoarthritis, Knee	365	Sodium hyaluronate	(vlcopondqd) = teqocyliqs xqgktwaggp (irxohmpfav ) View more	-	09 Jun 2004
ARVO2003	Not Applicable	-	83	Sodium Hyaluronate (Group 1)	(ynqaprrqxn) = vnhybygayq qtjpdsrsvw (geqdpntlnm )	Positive	01 May 2003
				Sodium Hyaluronate (Group 2)	(ynqaprrqxn) = pazlhiaicw qtjpdsrsvw (geqdpntlnm )