LCK inhibitors(Tyrosine-protein kinase LCK inhibitors), SRC inhibitors(Tyrosine-protein kinase SRC inhibitors), Syk inhibitors(Spleen tyrosine kinase inhibitors)

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Therapeutic Areas

Eye Diseases

Active Indication

Xerophthalmia

Inactive Indication-

Originator Organization

TopiVert Ltd.

Active Organization

TopiVert Ltd.

Inactive Organization

Topivert Pharma Ltd.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Clinical Trials associated with TOP-1630

NCT03833388 / CompletedPhase 2/3

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome

In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

Start Date13 Feb 2019

Sponsor / Collaborator

Topivert Pharma Ltd.

NCT03088605 / CompletedPhase 2

A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome

In subjects with Dry Eye Syndrome:
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Start Date20 Feb 2017

Sponsor / Collaborator

Beijing Orange Xin Data Technology Co., Ltd

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100 Clinical Results associated with TOP-1630

100 Translational Medicine associated with TOP-1630

100 Patents (Medical) associated with TOP-1630

Literatures (Medical) associated with TOP-1630

Clinical Ophthalmology

<p>A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease</p>

Article

Author: Webber, Steve ; Walshe, Claire ; Torkildsen, Gail ; Ousler, George ; Fyfe, Matthew C T ; Taylor, Mike ; Rowley, Adele ; Sheppard, John D ; Duggal, Ajay

PURPOSETo evaluate the safety and efficacy of topical TOP1630, a novel nonsystemic kinase inhibitor, in dry eye disease (DED).PATIENTS AND METHODSA randomized, double-masked, parallel-group trial of 0.1% TOP1630 ophthalmic solution TID or placebo (vehicle without active drug) was conducted in DED subjects (n=61). Key eligibility criteria consistent with enrolling a moderate to severe DED population included >6 months DED history; OSDI^© score ≥18; Schirmer's test score ≤10 and ≥1 mm/5 minutes; tear film break-up time >1 and <7 seconds; and dry eye exacerbation in corneal staining and ocular discomfort in a Controlled Adverse Environment (CAE^®). After a 7-day run-in period with placebo TID, eligible subjects were randomized to TOP1630 or placebo for 28 days. No supplemental artificial tears or rescue medication were allowed.RESULTSTOP1630 was safe, well-tolerated, and efficacious in treating DED symptoms and signs. No serious adverse events (AEs) or withdrawals due to treatment emergent AEs occurred. Drop comfort scores showed TOP1630 to be comfortable and comparable with placebo. Significant symptom improvements were seen for TOP1630 vs placebo for ocular discomfort (P=0.02 post-CAE), grittiness/foreign body sensation (on four independent assessment scales, each P<0.05), worst DED symptom (diary, P=0.06), and ocular pain (VAS, P=0.03). Sign improvements were seen for total ocular surface (all regions), corneal sum, and conjunctival sum staining with TOP1630 compared with placebo (each P<0.05).CONCLUSIONTOP1630 had placebo-like tolerability and produced improvements in multiple symptom and sign endpoints in both environmental and challenge settings. The emergent TOP1630 benefit-risk profile for DED treatment is highly favorable and supports further development.

100 Deals associated with TOP-1630

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Xerophthalmia	Phase 3	-	TopiVert Ltd.	-
Dry Eye Syndromes	Phase 1	US	TopiVert Ltd.	13 Feb 2019
Dry Eye Syndromes	Phase 1	US	Topivert Pharma Ltd.	13 Feb 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03088605 (CTgov)	Phase 2	Dry Eye Syndromes	69	TOP1630 Ophthalmic Solution (Active)	btmqhbgnub(xspnesmekm) = afqscsyzqs mrofvjvchq (ywaeeknpcj, nictrjwzee - vrroqtgurz) View more	-	14 Feb 2024
				Placebo to TOP1630 Ophthalmic Solution (Placebo)	btmqhbgnub(xspnesmekm) = kdemwxsbte mrofvjvchq (ywaeeknpcj, jmtfskjaqg - fsrzadtbik) View more
NCT03088605 (Pubmed) Manual	Phase 2	Dry Eye Syndromes	61	TOP1630	(uplocodgyb): P-Value = <0.05 View more	Positive	12 Feb 2019
				Placebo

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