Trial	Phase	Status	Sponsor	Enrollment	Dates
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.NCT01475643	Phase 3	Completed	Bausch & Lomb Incorporated	107	2013-06 → 2017-07
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis NCT03464435	Phase 4	Completed	Zhongshan Ophthalmic Center, Sun Yat-sen University	20	2016-11-01 → 2018-02-01
Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye NCT00560638	Phase 2	Completed	Bausch & Lomb Incorporated	119	2005-11 → 2006-02
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery NCT02208297	Phase 3	Completed	Bausch & Lomb Incorporated	326	2014-09 → 2015-03
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery NCT01060072	Phase 3	Completed	Bausch & Lomb Incorporated	407	2010-02 → 2010-10
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)NCT01435460	Phase 3	Completed	Bausch & Lomb Incorporated	300	2010-08 → 2011-05
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations NCT03098953	Phase 1	Completed	Bausch & Lomb Incorporated	15	2017-04-10 → 2017-05-12
Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium NCT04075227	Phase 4	Completed	Wannisa Suphachearabhan	108	2015-10-16 → 2019-03-02
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery NCT01010633	Phase 3	Completed	Bausch & Lomb Incorporated	406	2009-11 → 2010-08
Pediatric Zylet Safety and Efficacy Study NCT00420628	Phase 4	Completed	Bausch & Lomb Incorporated	108	2006-11 → 2009-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$103.20

per ml

Lowest NADAC/Unit

$103.20

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
71571012128INVELTYS 1% EYE DROP	$103.20	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$210.02

Highest Price

$266.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71571-0121-28INVELTYS 1% SUSP,OPH	$266.81	FSS	Alcon Vision, LLC	09/23/2026
71571-0121-28INVELTYS 1% SUSP,OPH	$210.02	Big4	Alcon Vision, LLC	09/23/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Inveltys (2024)

Total Spending

$1.6M

Total Claims

4,610

Beneficiaries

2,213

Avg Cost/Unit

$103.33

Spending Trend

$2.5M(2019)→$4.1M(2020)→$5.0M(2021)→$4.8M(2022)→$2.7M(2023)→$1.6M(2024)

YoY Change:-5.2%

5yr CAGR:+2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

ZACH SYSTEM SALOTEPREDNOL ETABONATE

DMF 111051994

INDUSTRIALE CHIMICA SRLLOTEPREDNOL ETABONATE

DMF 236722010

AARTI PHARMALABS LTDLOTEPREDNOL ETABONATE

DMF 262492012

FARMABIOS SPALOTEPREDNOL ETABONATE

DMF 269372013

FARMABIOS SPALOTEPREDNOL ETABONATE STERILE MICRONIZED

DMF 277172013

CURIA SPAIN SAULOTEPREDNOL ETABONATE STERILE MICRONIZED

DMF 280312014

SUN PHARMACEUTICAL INDUSTRIES LTDLOTEPREDNOL ETABONATE

DMF 323522018

CHEMO IBERICA SALOTEPREDNOL ETABONATE MICRONIZED STERILE

DMF 388172024

ALP PHARM BEIJING CO LTDInactiveLOTEPREDNOL ETABONATE

DMF 222782008

RELIANCE LIFE SCIENCES PVT LTDInactiveLOTEPREDNOL ETABONATE

DMF 254352011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2020	SUPPL -3	View Letter (PDF)
Aug 24, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

13 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Aug 22, 2018

Patents (13) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9056057	May 3, 2033	—	—	Yes		—
9393213	May 3, 2033	—	—	Yes	—	—
9532955	May 3, 2033	—	—	—		—
9737491	May 3, 2033	—	—	—		—
9827191	May 3, 2033	—	—	Yes		—
10058511	May 3, 2033	—	—	Yes		—
10646437	May 3, 2033	—	—	Yes	—	—
10688045	May 3, 2033	—	—	Yes	—	—
10864219	May 3, 2033	—	—	—		—
11219597	May 3, 2033	—	—	—		—
11642317	May 3, 2033	—	—	Yes	—	—
11872318	May 3, 2033	—	—	Yes	—	—
12115246	May 3, 2033	—	—	Yes		—