Delving into the Latest Updates on Loteprednol Etabonate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Loteprednol etabonate (JAN/USAN), Loteprednol Etabonate Ophthalmic Suspension, CDDD-5604

+ [13]

Target

GR x cPLA2α

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists), cPLA2α agonists(Cytosolic phospholipase A2 agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesNervous System Diseases+ [3]

Active Indication

Dry Eye SyndromesPainHerpes Zoster Ophthalmicus+ [10]

Inactive Indication

BlepharitisCataractDiabetic macular oedema+ [7]

Originator Organization

Bausch & Lomb, Inc.

Active Organization

Bausch & Lomb, Inc.Bausch & Lomb (Australia) Pty Ltd.Alcon Laboratories, Inc.

Inactive Organization

Kala Bio, Inc.Bausch Health Americas, Inc.

Sandoz Group AG

+ [2]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Mar 1998),

Conjunctivitis, AllergicConjunctivitisCyclitis+ [7]

Regulation-

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Structure/Sequence

Molecular FormulaC24H31ClO7

InChIKeyDMKSVUSAATWOCU-HROMYWEYSA-N

CAS Registry82034-46-6

Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Start Date22 Dec 2022

Sponsor / Collaborator

Virginia Polytechnic Institute & State University

[+1]

CTRI/2022/07/044211

/ Not yet recruitingPhase 3

A Multicentric Randomized Double Blind Double Dummy Parallel Group Two Arm Comparative Phase III Clinical Study to Evaluate Efficacy Safety and Tolerability of Loteprednol Etabonate Ophthalmic Suspension 1% w/v of Ajanta Pharma Ltd versus Loteprednol Etabonate Ophthalmic Suspension 0.5% w/v in treatment of Post-Operative Inflammatory conditions of Eye - Phase III

Start Date25 Jul 2022

Sponsor / Collaborator

Ajanta Pharma Ltd.

NCT05136443

/ CompletedPhase 4

Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty

The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.

Start Date23 Nov 2021

Sponsor / Collaborator

Price Vision Group

[+1]

100 Clinical Results associated with Loteprednol Etabonate

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100 Translational Medicine associated with Loteprednol Etabonate

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100 Patents (Medical) associated with Loteprednol Etabonate

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358

Literatures (Medical) associated with Loteprednol Etabonate

01 Sep 2025·American journal of ophthalmology case reports

Corneal pseudomicrocysts following claudin-6 antibody-drug conjugate infusion

Article

Author: Cooper, Caitlynn ; Meyer, Evan ; Sattarova, Victoria ; Rashidi, Vania ; Matuszewska, Laura ; Chanbour, Wassef

Purpose:

To report a case of bilateral corneal pseudomicrocysts associated with infusions of a novel antibody-drug conjugate targeting claudin-6, called TORL-1-23.

Observations:

A 47-year-old female with a history of advanced recurrent serous ovarian cancer presented to a level 1 tertiary care center with ocular irritation, redness, tearing, and light sensitivity following two infusions of TORL-1-23. Patient's past ocular history was unremarkable. The patient was enrolled in a phase 1 clinical trial for TORL-1-23, an antibody-drug conjugate (ADC). Nine days following the second infusion the patient presented to the ophthalmology clinic complaining of two weeks of bilateral eye discomfort, tearing, and photophobia. On examination, the patient had decreased visual acuity with a surface keratopathy associated with a whorled pattern of epithelial pseudomicrocysts in both eyes. Corneal changes were concentrated between the inferior limbus and central cornea. The remainder of the ophthalmic exam was unremarkable. Collagen and silicone punctal plugs were placed and the patient was started on preservative free artificial tears, topical loteprednol 0.5 %, later replaced with topical prednisolone acetate 1 % drops, and brimonidine 0.2 % in both eyes. The patient developed neuropathy which necessitated a decrease in ADC dosage and the patient's symptoms subsequently improved. However, a decrease in visual acuity and increase in corneal pseudomicrocysts was seen after the fifth infusion. Corneal disease improved with the placement of new collagen punctal plugs and addition of cyclosporine 0.05 % eye drops in both eyes. Ocular symptoms and exam findings waxed and waned with continued infusions of the ADC.

Conclusions and importance:

This case reports an incidence of corneal pseudomicrocysts associated with TORL-1-23 treatment, which should be recognized as a potential adverse effect of this novel therapy.

01 Aug 2025·FOOD CHEMISTRY

Investigation into the effects of acute heat stress on stress level, meat quality, myofibrillar proteins properties and serum metabolites release of Muscovy ducks (Cairina moschata)

Article

Author: Huang, Tianran ; Xiao, Mengchao ; Huang, Jichao ; Li, Zimu ; Zhu, Zongshuai ; Huang, Ming

This study systematically investigated the effects of acute heat stress (AHS) on Muscovy ducks, focusing on plasma stress indicators, meat quality, myofibrillar proteins (MPs) properties, and serum metabolite profiles. AHS significantly elevated stress level, impairing meat quality, as evidenced by higher L* value, shear force, drip loss, and cooking loss (P < 0.05). It also induced MPs oxidation and aggregation, reflected by elevated carbonyl content, turbidity, zeta potential, and particle size. MPs structural alterations were confirmed by fluorescence quenching and increased exposure of hydrophobic groups. Correlation analysis revealed strong associations between physicochemical changes and MPs oxidation. Metabolomic analysis identified 161 and 105 differential metabolites in the CON vs. LS and CON vs. SS comparisons, respectively, involving 25 metabolic pathways related to energy, amino acids, and fatty acids. These findings provide novel insights into the molecular pathways of AHS-induced meat quality deterioration and reveal potential intervention timing for the poultry industry.

18 Jul 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Which topical ophthalmic drugs work best for Keratoconjunctivitis Sicca? A systematic review and meta-analysis.

Article

Author: Chen, Kai-Yang ; Chan, Chi-Ming ; Chan, Hoi-Chun

BACKGROUND:

Dry Eye Disease (DED) is a chronic and multifactorial condition that significantly impacts patient quality of life. Topical ophthalmic drugs (TODs) have emerged as key treatments for DED, offering the potential to address the underlying pathology rather than merely alleviating symptoms. This review aims to assess the efficacy of various TODs in managing the symptoms of DED.

METHODS:

A comprehensive search was conducted across three electronic databases to identify relevant articles for inclusion in this review. Two independent authors screened the articles according to predefined eligibility criteria. A total of 16 randomized controlled trials (RCTs) were included, summarizing data from 2,680 patients. The data were analyzed using Review Manager 5.4, with pooled analysis conducted on key symptoms including corneal fluorescein staining (CFS), Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), and Schirmer test scores.

RESULTS:

From 632 articles identified, 16 RCTs were selected for inclusion. The pooled analysis revealed that cyclosporine therapy resulted in a significant improvement in CFS scores (mean difference (MD) -0.24; 95% confidence interval (CI) (-0.42, -0.07), P = 0.006). However, no significant improvements were observed in OSDI, TBUT, or Schirmer test scores (MD -0.35; 95% CI (-5.66, 4.96), P = 0.9; MD 0.12; 95% CI (-0.65, 0.89), P = 0.76; MD -0.22; 95% CI (-0.46, 0.02), P = 0.07, respectively). Similar results were found for loteprednol etabonate (LE) and diquafosol sodium, with no significant changes in OSDI, CFS, or Schirmer test scores. For diquafosol, no significant improvements were observed in any of the DED symptoms, including OSDI (MD -3.82; 95% CI (-8.31, 0.67), P = 0.10), CFS (MD -0.31; 95% CI (-0.82, 0.20), P = 0.23), TBUT (MD -0.20; 95% CI (-1.37, 0.98), P = 0.74), and Schirmer test (MD -1.00; 95% CI (-2.60, 0.60), P = 0.22).

CONCLUSION:

The study concluded that cyclosporine therapy offers improvements in corneal fluorescein staining but does not significantly affect other common DED symptoms, such as OSDI, TBUT, and Schirmer test scores. Similarly, no significant improvements in DED symptoms were observed with loteprednol etabonate or diquafosol sodium. Further research is needed to explore the efficacy of these treatments in managing DED symptoms more comprehensively.

50

News (Medical) associated with Loteprednol Etabonate

29 May 2025

·www.fiercepharma.com

Alcon gains first FDA prescription drug nod since Novartis split, scoring with drops for dry eye disease

Alcon has gained its first FDA nod for a prescription product since its 2019 split with Novartis, securing an approval for dry eye disease treatment Tryptyr. Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease (DED) treatment Tryptyr (acoltremon ophthalmic solution).Tryptyr, which is administered as a single drop twice daily, is a first-in-class TRPM8 receptor agonist intended to activate tear production. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of (DED),” Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, said in a release.There are roughly 38 million in the U.S. who have DED. Fewer than 10% of those who have been diagnosed are being treated with a prescription product, according to Alcon.“We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy,” David Endicott, CEO of Alcon, said in a release, adding that the approval was a “tremendous milestone” for the 80-year-old company. The company said it expects to launch Tryptyr in the third quarter.Backing the nod were two phase 3 trials that included more than 930 DED patients. In one study, 43% of patients on Tryptyr had a 10-millimeter increase in natural tear production on the Schirmer test at Day 14, compared to 8% of those on vehicle. In another study, the figures came in at 53% versus 14%, favoring the Tryptyr arm.After operating as a Novartis subsidiary for eight years, Alcon split from the Swiss pharma giant in 2019. Since then, Alcon has been on a growth splurge. In 2022, it paid $770 million to acquire Aerie Pharmaceuticals and its marketed glaucoma and ocular hypertension meds Rhopressa and Rocklatan. The company also ponied up $355 million to gain U.S. rights to Novartis’ Simbrinza, which treats the same ocular conditions. Also in 2022, Alcon gained DED treatment Eysuvis as part of a $60 million transaction with struggling Kala Pharmaceuticals.In addition, two months ago, Alcon secured a majority stake in clinical-stage company Aurion Biotech.In February, Alcon reported 2024 revenue at $9.8 billion, which was up 5% from the prior year.

Clinical ResultAcquisitionPhase 3Drug Approval

29 May 2025

·firstwordpharma.com

Alcon's dry eye treatment Tryptyr secures FDA nod

The FDA approved Alcon's Tryptyr (acoltremon) eye drops for managing dry eye disease (DED), marking the first prescription product approved for the eye care company since its spin-out from Novartis as an independent publicly traded company.“We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy," said Alcon CEO David Endicott. Tryptyr, earlier codenamed AR-15512, entered Alcon’s portfolio in 2022 through its acquisition of Aerie Pharmaceuticals for nearly $770 million.With this approval — the first-in-class TRPM8 receptor agonist that stimulates corneal sensory nerves to rapidly increase natural tear production — gains a lead in DED therapeutics over Aldeyra’s investigational RASP modulator reproxalap rejected twice by the FDA, initially in 2023 and once again last month.Tryptyr’s approval is supported by robust clinical data from the Phase III COMET-2 and COMET-3 trials. Results showed that participants receiving Tryptyr experienced at least a 10 mm increase in natural tear production at day 14 compared with control vehicle — 42.6% versus 8.2% in COMET-2 and 53.2% versus 14.4% in COMET-3. Notably, Tryptyr demonstrated significant tear production as early as day 1, with consistent results maintained through day 90. Alcon noted that Tryptyr will be available as a 0.003% ophthalmic solution in single-dose vials for twice-daily administration. The company anticipates a US launch in the third quarter, with international market expansion plans on the cards. Earlier this month, Stifel analysts seemed optimistic about the drug’s approval but flagged concerns that may temper its launch, including transient burning or stinging side effects and mixed symptomatic results that could limit labelling, alongside growing competition in the DED space.Besides Tryptyr, other FDA-approved DED therapies include Alcon's Eysuvis (loteprednol etabonate) — bought from Kala Pharmaceuticals in 2022 and Bausch + Lomb's Xiidra (lifitegrast) — gained from Novartis a year later. Alcon also markets a range of over-the-counter dry-eye products such as Systane Dry Eye Drops and GenTeal Tears.

Clinical ResultPhase 3Drug ApprovalAcquisition

29 May 2025

·pharma.economictimes.indiatimes.com

US FDA approves Alcon's new dry-eye drug

Bengaluru: Eye-care drugmaker Alcon said on Wednesday that the U.S. Food and Drug Administration has approved its treatment for dry eye disease (DED). Spun off from Novartis in 2019, Alcon is betting on new product launches to accelerate sales growth in the second half of 2025 and beyond. The approval was based on late-stage studies in which the liquid medication, Tryptyr, demonstrated natural tear production as early as day one. The company said Tryptyr stimulates corneal sensory nerves to quickly increase natural tear production. DED is a condition in which the eyes either do not produce enough tears or produce poor-quality tears, leading to discomfort and potentially affecting vision. The company said about 38 million individuals in the United States suffer from DED, yet fewer than 10% of diagnosed patients are being treated with a prescription product. Alcon, which produces contact lenses , dry eye drops, gels and other related products, expects to launch Tryptyr in the United States during the third quarter of 2025, with plans to introduce the treatment in other markets later. Other FDA-approved treatments for DED include Alcon's Eysuvis and Bausch + Lomb's Xiidra. Last month, however, the FDA declined to approve Aldeyra Therapeutics' treatment for DED. (Reporting by Puyaan Singh in Bengaluru; Editing by Mohammed Safi Shamsi)

Drug Approval

100 Deals associated with Loteprednol Etabonate

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External Link

KEGG	Wiki	ATC	Drug Bank
D01689	Loteprednol Etabonate	S01BA14	DB14596

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dry Eye Syndromes	United States	Alcon Laboratories, Inc.	26 Oct 2020
Pain	United States	Bausch & Lomb, Inc.	15 Apr 2011
Herpes Zoster Ophthalmicus	China	Bausch & Lomb, Inc.	10 Jan 2007
Conjunctivitis	United States	Bausch & Lomb, Inc.	09 Mar 1998
Conjunctivitis, Allergic	United States	Bausch & Lomb, Inc.	09 Mar 1998
Cyclitis	United States	Bausch & Lomb, Inc.	09 Mar 1998
Iritis	United States	Bausch & Lomb, Inc.	09 Mar 1998
Keratitis	United States	Bausch & Lomb, Inc.	09 Mar 1998
Keratitis, Herpetic	United States	Bausch & Lomb, Inc.	09 Mar 1998
Ocular inflammation	United States	W World Corp.	09 Mar 1998
Post procedural inflammation	United States	Bausch & Lomb, Inc.	09 Mar 1998
Rosacea	United States	Bausch & Lomb, Inc.	09 Mar 1998
Seasonal allergic conjunctivitis	United States	Bausch & Lomb, Inc.	09 Mar 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kerato conjunctivitis sicca	Phase 3	United States	Kala Bio, Inc.	01 Jun 2016
Pain, Postoperative	Phase 3	United States	Kala Bio, Inc.	01 Jun 2016
Eye Infections	Phase 3	United States	Kala Bio, Inc.	01 May 2014
Cataract	Phase 3	United States	Bausch & Lomb, Inc.	01 Jun 2013
Blepharitis	Phase 2	United States	Kala Bio, Inc.	01 Jul 2014
Meibomian Gland Dysfunction	Phase 2	United States	Kala Bio, Inc.	01 Jul 2014
Postoperative Complications	Phase 1	Canada	Sandoz International GmbH	26 Apr 2018
Eye Pain	Phase 1	United States	Bausch Health Americas, Inc.	01 Feb 2015
Diabetic macular oedema	Clinical	United States	Kala Bio, Inc.	01 Jul 2014
Retinal Vein Occlusion	Clinical	United States	Kala Bio, Inc.	01 Jul 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05136443 (CTgov)	Phase 4	Graft Rejection \| Corneal Edema \| Iridocorneal Endothelial Syndrome	70	loteprednol etabonate 0.25% ophthalmic suspension	lzvtmyqftw = xoepqlgiys kjmiwlrpcn (edchfvgzoc, idflvnovrj - vsmrppizaq) View more	-	14 Aug 2024
NCT05136443 (Pubmed \| Cornea) Manual	Phase 4	Fuchs' Endothelial Dystrophy	70	Loteprednol Etabonate 0.25% ophthalmic suspension	pgikdcnvke(nqjcyorgeq) = knoahyjxwj moacchqrdl (bvohgiogem ) View more	Positive	01 Aug 2024
NCT04555694 (CTgov)	Phase 4	Dry Eye Syndromes	30	Cyclosporine+loteprednol etabonate (Restasis and Lotemax)	lcslpwwmpk(uvzbizbzvw) = mlswxkkuid fxtbzezsun (tfaryopvev, 1.5) View more	-	11 Oct 2023
				Cyclosporine+Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert (Restasis and Dextenza)	lcslpwwmpk(uvzbizbzvw) = ncwsegiorq fxtbzezsun (tfaryopvev, 1.0) View more
NCT02120079 (CTgov)	Phase 4	Dry Eye Syndromes	37	In Vivo Confocal Microscopy (IVCM)+Lotemax (Lotemax)	nvjpnkhkij(iiphlnrfpe) = idxxpvhmsc oevbgpqvbq (fdfwfgqfzy, 5.13) View more	-	23 Mar 2022
				In Vivo Confocal Microscopy (IVCM)+Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) (Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears))	nvjpnkhkij(iiphlnrfpe) = muaxisqyzq oevbgpqvbq (fdfwfgqfzy, 26.09) View more
AAO2021	Not Applicable	Nummular eczema	100	Tacrolimus 0.1%	zkvrupszkb(zllhhokhup) = mzxewcorab rehxprcqgl (lqqoedbtfc )	-	13 Nov 2021
				Loteprednol 0.5%	zkvrupszkb(zllhhokhup) = glbfkuyfqb rehxprcqgl (lqqoedbtfc )
ARVO2021	Not Applicable	-	-	Loteprednol etabonate (submicron) ophthalmic gel 0.38%	spmfbdgyaf(kqniehrhyp) = viqfbykkvd hfdjmqxofx (haohmzozdq, 1.3)	-	01 Jun 2021
				Prednisolone acetate ophthalmic suspension 1.0%	spmfbdgyaf(kqniehrhyp) = gnottkvdrc hfdjmqxofx (haohmzozdq, 1.39)
ARVO2021	Not Applicable	-	-	Loteprednol Etabonate Eluting Adhesive Ocular Patch	aksjmxfcqg(jpzsofrooa) = qsjwvofaov xxoinnsaxw (qjrtweyext ) View more	-	01 Jun 2021
NCT03616899 (STRIDE 3, CTgov)	Phase 3	Kerato conjunctivitis sicca	901	KPI-121 Ophthalmic Suspension (KPI-121 0.25% Ophthalmic Suspension)	wtlnpfweho(grjqizwohe) = phaivofcou lkivaioapo (thhyoboiao, 19.379) View more	-	02 Apr 2021
				Vehicle (Vehicle of KPI-121 0.25% Ophthalmic Suspension)	wtlnpfweho(grjqizwohe) = kuxzbgpogd lkivaioapo (thhyoboiao, 17.579) View more
NCT02218489 (Maui, CTgov)	Phase 2	Blepharitis \| Meibomian Gland Dysfunction	206	Vehicle (Vehicle)	ivxorxbzia(jowfezcwkh) = oskwacqgbs svragkkyjd (ectxosypul, 13.8) View more	-	11 Jan 2021
				KPI-121 (KPI-121 0.25% Ophthalmic Suspension)	ivxorxbzia(jowfezcwkh) = kisbybhats svragkkyjd (ectxosypul, 16.7) View more
NCT02188160 (Kauai, CTgov)	Phase 2	Kerato conjunctivitis sicca	150	KPI-121 (KPI-121 0.25% Ophthalmic Suspension)	zccmgjlgtq(cpwmpwzsay) = xnlbzbdein zjaxjgjlla (fmkacjhcum, 0.633) View more	-	06 Jan 2021
				Placebo (Vehicle)	zccmgjlgtq(cpwmpwzsay) = mbtfbjxnik zjaxjgjlla (fmkacjhcum, 0.626) View more