Delving into the Latest Updates on Nepafenac with Synapse

A randomized, open-label trial was conducted in women aged 45-65 years with breast cancer (stages I-III) who had completed oncological treatment (excluding endocrine therapy) and reported vaginal symptoms (vaginal dryness and/or dyspareunia). Participants were randomized into two groups: one group used a vaginal moisturizer (three times per week, at night, n = 50) and the other a vaginal lubricant (during sexual intercourse, n = 50). The 16-week intervention included assessments at baseline, 8, and 16 weeks.

MAIN OUTCOME MEASURES:

Vaginal and vulvar health were assessed using the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Vaginal Health Index (VHI), vaginal pH, and Vaginal Maturation Index (VMI). The primary outcome was improvement in vaginal health as measured by the VHI.

RESULTS:

Of the 100 randomized women, 12 discontinued the study (4 in the moisturizer group and 8 in the lubricant group). Adherence to the moisturizer was high (85.9%) and no serious adverse events were reported. At 8 and 16 weeks, the moisturizer group showed significant improvement in VAS (p = 0.014) and VuAS (p = 0.003) scores, as well as a significant increase in VHI scores, indicating improvements in elasticity, moisture, fluid volume, epithelial integrity, and pH (p < 0.0001) compared with the control group. Vaginal pH significantly decreased in the moisturizer group compared with the control group (p = 0.016). No significant between-group differences were observed in VMI scores after 16 weeks (p = 0.213).

CONCLUSIONS:

The non-hormonal vaginal moisturizer was effective in improving vaginal and vulvar health parameters in postmenopausal women with breast cancer compared with a vaginal lubricant. Brazilian Clinical Trials Registry (ReBEC,) number RBR-5cf7vzj.

04 Mar 2026·DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Novel stable micellar formulation for ocular delivery of nepafenac: optimization, characterization and in-vitro evaluation

Article

Author: Sorathia, Kishorkumar ; Vashi, Ronak

OBJECTIVE:

The objective of this study was to develop a stable clear ophthalmic nano-micellar formulation of Nepafenac.

SIGNIFICANCE:

The current marketed suspension formulation of nepafenac indicated for post-surgical uveitis is associated with higher manufacturing complexity and cost due to the need for sterile drug substance and specialized aseptic processing inherent to suspension-based ophthalmic products. It also exhibits limitations in patient compliance due to relatively high viscosity, lacrimation, and foreign body sensation following instillation.

METHODS:

Pre-formulation study was done to identify the excipients required. Systematic changes in the concentration of surfactant and crystal inhibitor along with other excipients led to the development of stable nano-micellar formulation. Box-behnken method was used for the optimization. The optimized micellar composition was evaluated for physicochemical tests particle size, zeta potential, cloud point, osmolality pH, assay of drug, entrapment efficiency and dynamic viscosity. Further in-vitro cell viability, in-vitro release, ocular tolerance test and stability evaluation were also performed.

RESULTS:

Average particle size of the micelle ranged from 10 to 20 nm, 43.5 mPas dynamic viscosity, osmolality of 319 mOsm/Kg, pH 7.4 and cloud point of 59.7 °C. The optimized formulation demonstrated in-vitro safety as confirmed by MTT cell viability and HET-CAM ocular irritation assays, and exhibited physicochemical stability for up to 6 months under real-time storage conditions.

CONCLUSION:

The optimized micelle formulation can serve as a better alternative for ophthalmic delivery of nepafenac.

01 Jan 2026·JOURNAL OF REFRACTIVE SURGERY

Efficacy of Topical Nepafenac Versus Nepafenac With Perioperative Cyclopentolate for Pain Management After Photorefractive Keratectomy: A Comparative Clinical Evaluation

Article

Author: Citron, Shira ; Levinger, Eliya ; Achiron, Asaf ; Eilon, Elad ; Klinghoffer, Ben

Purpose::

To compare the efficacy of topical nepafenac alone versus nepafenac combined with cyclopentolate for pain management after photorefractive keratectomy (PRK) through a comprehensive evaluation of pain intensity, stinging, tearing, light sensitivity, analgesic use, and sleep disturbance.

Methods::

This was a retrospective comparative study using data from a randomized controlled trial registry. A total of 160 patients undergoing PRK were analyzed. Patients were randomized to receive a standard nepafenac regimen either alone or with the addition of perioperative cyclopentolate 1%. Pain, stinging, tearing, and light sensitivity were rated on a visual analog scale (0 to 10) twice daily for 5 postoperative days. Sleep disturbance and analgesic use were also recorded.

Results::

The nepafenac-only group reported significantly lower pain score means over the 5 days compared to the nepafenac + cyclopentolate group (3.48 ± 2.25 vs 5.42 ± 3.20, P < .001). Secondary outcomes also favored the nepafenac-only group with lower reported levels of stinging sensation (1.72 ± 1.88 vs 5.86 ± 3.36, P < .001), tearing (4.43 ± 3.32 vs 5.45 ± 3.60, P < .001), and light sensitivity (3.75 ± 3.32 vs. 4.47 ± 3.60, P < .001). Moreover, sleep disturbance was less frequent in the nepafenac-only group during the first two postoperative nights ( P < 0.01).

Conclusions::

Contrary to theoretical expectations, adding cyclopentolate to nepafenac therapy worsened postoperative pain outcomes after PRK. For optimal pain management, a regimen of nepafenac alone appears superior to the combination therapy approach.

8

News (Medical) associated with Nepafenac

18 Mar 2026

·www.globenewswire.com

Harrow Announces Three Abstracts Accepted for Presentation at ASCRS 2026 Annual Meeting

NASHVILLE, Tenn., March 18, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that three scientific abstracts highlighting its commercial products VEVYE® (cyclosporine ophthalmic solution) 0.1% and ILEVRO® (nepafenac ophthalmic suspension) 0.3% have been accepted for presentation at the American Society of Cataract and Refractive Surgery (ASCRS) 2026 Annual Meeting, taking place April 10–13 at the Walter E. Washington Convention Center in Washington, D.C. The accepted research underscores Harrow’s continued commitment to advancing evidence-based treatment options for ophthalmic diseases, including dry eye disease and post-cataract surgery complications. The abstracts will be presented in the following scientific sessions: Ocular Surface DiseaseDate: Saturday¸ April 11, 2026Time: 8:00 AM – 9:30 AM VEVYE: Real-World Treatment Patterns and Clinical Outcomes with Cyclosporine 0.1% in Semifluorinated Alkane for Dry Eye Disease Presenter: A. Epitropoulos, MD VEVYE: Dual-Function Cyclosporine 0.1% in Perfluorobutylpentane as an Alternative to Corticosteroids in Post-Fungal Keratoplasty Presenter: T. Shoshany, MD Medications (Preoperative, Postoperative, Intraoperative)Date: Sunday, April 12, 2026Time: 8:00 AM – 9:30 AM ILEVRO: Post-Hoc Analysis of the Effect of Nepafenac 0.3% on Reducing Clinically Significant Visual Acuity Loss Associated with Cataract Surgery in subjects with Macular Edema Presenter: I. Mac, MD The ASCRS Annual Meeting is one of the world’s premier gatherings for ophthalmic surgeons and ophthalmic professionals, showcasing the latest clinical research, surgical techniques, and therapeutic innovations in ophthalmology. Additional details regarding the abstracts and supporting data will be available at the time of presentation. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and retina diseases. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts:Mike BiegaVice President of Investor Relations and Communications mbiega@harrowinc.com617-913-8890

26 Sep 2023

·www.prnewswire.com

MATI THERAPEUTICS ANNOUNCES PROMOTION OF CHRIS MULLER TO CHIEF OPERATING OFFICER

Industry Veteran with over 30 years of ophthalmic experience to guide development and commercial efforts for Mati's expanding late-stage pipeline, including two products about to enter Phase III trials. AUSTIN, Texas, Sept. 26, 2023 /PRNewswire/ -- Mati Therapeutics Inc. ("Mati") announced that it has promoted Chris Muller to the position of Chief Operating Officer. He formerly held the position of Chief Commercial Officer. Mr Muller's expanded responsibilities include broad management of all operating activities, and preparation for and execution of the commercial launch of Mati's proprietary Evolute® sustained ocular drug delivery platform. "Chris has an outstanding record of achievement from his 30+ years of ophthalmic industry experience, including multiple product launches in glaucoma, inflammation, and anti-infectives, followed by extensive experience in refractive surgery, cataract surgery, dry eye, contact lens, and OTC care. Chris has unique qualifications to help Mati achieve our development and commercialization goals, especially since our first three programs focus on the post-operative cataract market and glaucoma," said Bob Butchofsky, CEO of Mati. "Following the recently announced completion of our dedicated manufacturing facility, Chris will lead efforts to complete our upcoming Phase III trial for nepafenac for post-cataract pain and hire personnel and lead our commercial efforts as we pursue FDA approval." Mr. Muller started his ophthalmic career at Allergan, where he held various positions of increasing responsibility from 1990 to 2005. He held positions in Field Sales, Medical Marketing, as well as senior leadership positions in U.S. and global marketing. Chris then joined AMO/Abbott and was head of their Eye Care, Medical Marketing and Refractive divisions globally. About Mati Therapeutics Inc. Mati is developing the Evolute® sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications. The platform utilizes a device called a punctal plug, which is easily inserted into a patient's punctum, or tear duct. The device has already been approved to treat dry eye syndrome, but Mati is the first company to conduct clinical trials in the U.S. using punctal plugs as an anchoring device for a drug delivery platform. A drug-eluting core is inserted into Mati's proprietary punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. Mati believes the Evolute® platform has the potential to become a more reliable alternative to several eye drop therapies, which can be ineffective because many patients are unwilling or unable to adhere to self-administered eye-drop regimens. Mati's proprietary punctal plug design has demonstrated excellent lower punctum retention rates of 92% and 96% over a 12-week follow-up period in two separate multi-center U.S. clinical trials. Mati has two candidates ready to enter Phase III pivotal trials including nepafenac for post-operative pain and dexamethasone for post-operative inflammation, both following cataract surgery. Additionally, Mati is developing travoprost, which is in Phase II trials for the treatment of glaucoma and ocular hypertension. To learn more about Mati Therapeutics, visit . Contact: Bob Butchofsky, CEO Mati Therapeutics Inc. +1 512 720-1333 [email protected] SOURCE Mati Therapeutics

Executive ChangePhase 2Phase 3

12 Sep 2023

·www.prnewswire.com

MATI THERAPEUTICS ANNOUNCES COMPLETION OF MANUFACTURING FACILITY DEDICATED TO GLOBAL PRODUCTION OF ALL PUNCTAL PLUG DELIVERY SYSTEM (PPDS) PRODUCTS

Completion of Facility Enables Initiation of Phase 3 Clinical Trial of Nepafenac in Patients Undergoing Cataract Surgery AUSTIN, Texas, Sept. 12, 2023 /PRNewswire/ -- Mati Therapeutics Inc. ("Mati") announced that it has completed and now occupies a facility dedicated to manufacturing all products formulated in Mati's proprietary Evolute® sustained ocular drug delivery platform. The 10,000 square foot facility is located in Bryan, Texas and has the capacity to fulfill all manufacturing needs for both development and commercial purposes for the foreseeable future. Mati engineers designed, built, and programmed each of the robotic devices used in a multi-step process to manufacture each product in the Evolute® platform. "Following pandemic-related disruptions to global supply chains, we determined it was both time and cost effective to directly control the manufacturing process for all of the product candidates in our pipeline," said Bob Butchofsky, CEO of Mati. "Following completion and occupancy of this facility, we are now in position to initiate a Phase 3 trial of nepafenac to treat post-operative pain in patients undergoing cataract surgery. We expect to begin this trial in the coming weeks. Our ability to control our manufacturing schedule will reduce potential delays from ongoing supply chain interruptions, provide more flexibility in our development efforts, and will greatly reduce our commercial cost of goods sold." About Mati Therapeutics Inc. Mati is developing the Evolute® sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications. The platform utilizes a device called a punctal plug, which is easily inserted into a patient's punctum, or tear duct. The device has already been approved to treat dry eye syndrome, but Mati is the first company to conduct clinical trials in the U.S. using punctal plugs as an anchoring device for a drug delivery platform. A drug-eluting core is inserted into Mati's proprietary punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. Mati believes the Evolute® platform has the potential to become a more reliable alternative to several eye drop therapies, which can be ineffective because many patients are unwilling or unable to adhere to self-administered eye-drop regimens. Mati has two candidates ready to enter Phase III pivotal trials including nepafenac for post-operative pain and dexamethasone for post-operative inflammation, both following cataract surgery. Additionally, Mati is developing travoprost, which is in Phase II trials for the treatment of glaucoma and ocular hypertension. Mati's proprietary punctal plug design has demonstrated excellent lower punctum retention rates of 92% and 96% over a 12-week follow-up period in two separate multi-center U.S. clinical trials. To learn more about Mati Therapeutics, visit . Contact: Bob Butchofsky, CEO Mati Therapeutics Inc. +1 512 720-1333 [email protected] SOURCE Mati Therapeutics

Phase 2Phase 3

100 Deals associated with Nepafenac

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External Link

KEGG	Wiki	ATC	Drug Bank
D05143	Nepafenac	S01BC10	DB06802

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Macular Edema	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	04 Nov 2015
Post procedural inflammation	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	04 Nov 2015
Ocular inflammation	Japan	Novartis Pharma KK	27 Oct 2010
Diabetic macular oedema	European Union	Novartis Europharm Ltd.	11 Dec 2007
Diabetic macular oedema	Iceland	Novartis Europharm Ltd.	11 Dec 2007
Diabetic macular oedema	Liechtenstein	Novartis Europharm Ltd.	11 Dec 2007
Diabetic macular oedema	Norway	Novartis Europharm Ltd.	11 Dec 2007
Pain, Postoperative	European Union	Novartis Europharm Ltd.	11 Dec 2007
Pain, Postoperative	Iceland	Novartis Europharm Ltd.	11 Dec 2007
Pain, Postoperative	Liechtenstein	Novartis Europharm Ltd.	11 Dec 2007
Pain, Postoperative	Norway	Novartis Europharm Ltd.	11 Dec 2007
Inflammation	United States	Harrow, Inc.	19 Aug 2005
Pain	United States	Harrow, Inc.	19 Aug 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonproliferative diabetic retinopathy	Phase 3	-	Alcon Research Ltd.	01 Jun 2013
Eye Pain	Phase 3	France	Alcon Research Ltd.	01 Nov 2005
Cataract	Phase 3	United States	Alcon Research Ltd.	01 Sep 2005
Conjunctivitis, Bacterial	Phase 2	-	Alcon Research Ltd.	01 Jan 2011
Diabetic Retinopathy	Phase 2	-	Alcon Research Ltd.	01 Nov 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03499873 (CTgov)	Phase 3	Cataract \| Pain \| Inflammation ... View more	448	Nepafenac (Nepafenac 0.3% Opthalmic Suspension)	gxegbidgbl: Mean Difference (Net) = -0.026 (90% CI, -0.124 to 0.073)	-	16 Feb 2021
				Nepafenac (Ilevro 0.3% Opthalmic Suspension)
NCT03025945 (CTgov)	Not Applicable	Macular Edema	662	Nepafenac 0.3% (Nepafenac 0.3%)	bpkvugdazx(xrwaeyasff) = ceqmmmcode hszqbmsoom (umftvwvdyp, 0.13) View more	-	14 Dec 2018
				Saline Solution (Saline Solution)	bpkvugdazx(xrwaeyasff) = gvujhvtege hszqbmsoom (umftvwvdyp, 0.18) View more
NCT01847638 (QD, CTgov)	Not Applicable	Cataract \| Ocular inflammation \| Retinal oedema	50	bromfenac (Prolensa (Bromfenac 0.07%))	nfvpeqnqzj(gfqtauljuc) = fzgqkgemws zlvkqkmqog (motqtsngee, .3) View more	-	14 Nov 2018
				nepafenac (Ilevro (Nepafenac 0.3%))	nfvpeqnqzj(gfqtauljuc) = sdeounomzn zlvkqkmqog (motqtsngee, .4) View more
NCT02515045 (CTgov)	Phase 4	Cataract	59	triamcinolone+moxifloxacin+vancomycin (TriMoxiVanc)	etsesvucns(bcumxbnenv) = kblxhhqcxf evhfkruvzd (iylkziqzjo, 13.05) View more	-	22 Aug 2017
				triamcinolone+moxifloxacin+vancomycin+Ilevro (TriMoxiVanc + Ilevro)	etsesvucns(bcumxbnenv) = peuafexuhg evhfkruvzd (iylkziqzjo, 11.55) View more
NCT01853072 (Pubmed \| Ophthalmology) Manual	Phase 3	Diabetic Retinopathy	615	Nepafenac	ophbtntxbj(rtzbnibqko) = rfhpxuxjnk erkoaxudmu (wtxlzgufgo ) View more	Positive	01 Jun 2017
				vehicle	ophbtntxbj(rtzbnibqko) = yojecopgyf erkoaxudmu (wtxlzgufgo ) View more
NCT00939276 \| NCT00782717 (Pubmed \| Br J Ophthalmol)	Phase 2	Diabetic Retinopathy	175	Nepafenac ophthalmic suspension 0.1%	snyfsyxtqq(ppkwmbmfzy) = pezhsffqrz mwbfgwtsak (wpattpgmkj, 1.4 - 12.3) View more	-	01 Apr 2017
				Vehicle	snyfsyxtqq(ppkwmbmfzy) = prvwnvwljr mwbfgwtsak (wpattpgmkj, 9.9 - 27.6) View more
APAO2017	Phase 3	Diabetic cataract	-	Nepafenac 0.3%	ktgihlpdic(scbbhrmbsf) = Rates of treatment-related adverse events were low in both groups (study-1: 2.7% vs 2.3%; study-2: 2.0% vs 2.7%) tfnszosqqj (whovamkgrx )	Positive	01 Mar 2017
				Vehicle
NCT03025945 (Pubmed \| BMC Ophthalmol)	Not Applicable	Macular Edema	1,000	Topical nepafenac 0.3%	inmzxtijgk(idnruaxppy) = drtoakimaj mhxmkoxmkc (qgolmbznge )	-	20 Feb 2017
				Placebo	inmzxtijgk(idnruaxppy) = bolohqszya mhxmkoxmkc (qgolmbznge )
NCT01331005 (Pubmed \| Retina) Manual	Phase 2	Diabetic macular oedema	125	nepafenec	czhajnsibv(jkqhzqfyrt) = zlewwglewq dyixlzbdhg (hhcniepuhg ) View more	Negative	01 May 2015
				Placebo	czhajnsibv(jkqhzqfyrt) = xruygmxipc dyixlzbdhg (hhcniepuhg ) View more
NCT01331005 (CTgov)	Phase 2	Diabetic macular oedema	125	Nepafenac Vehicle (Placebo)	gsxsdrmwtg(nqgfrxovow) = ndzajcvmkw omcnzbnvsn (huacyiajkg, eqvymuormr - hxtvgywizl) View more	-	16 Jan 2015
				nepafenac (Nepafenac 0.1% Drops)	gsxsdrmwtg(nqgfrxovow) = yktygaxrqr omcnzbnvsn (huacyiajkg, ayspjbgspl - mcyiqdnpfa) View more