Harrow Provides TRIESENCE® Relaunch Update
June 20 2024 - 7:00AM
Business Wire
Successful Manufacture of TRIESENCE PPQ
Batch Leads to Scheduling of Remaining Process Qualification Steps,
Initial Inventory Build, and Pre-Commercial Activities
Harrow (Nasdaq: HROW), a leading North American eyecare
pharmaceutical company, is pleased to announce the successful
manufacture of the first of three commercial-scale process
performance qualification (PPQ) batches of TRIESENCE®
(triamcinolone acetonide injectable suspension) 40 mg/mL, a
preservative-free synthetic corticosteroid that is FDA‑approved for
visualization during vitrectomy and for the treatment of ocular
inflammatory conditions that are unresponsive to topical
corticosteroids. Harrow also announced that the second and third
required PPQ batches are now scheduled; and should these PPQ
batches meet specifications, the new TRIESENCE production process
will be deemed complete, allowing Harrow to relaunch during
2024.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240620854415/en/
TRIESENCE (Photo: Business Wire)
TRIESENCE has been on the FDA Drug Shortage List for over five
years with all TRIESENCE inventories having been depleted in the
U.S. market for over two years. Harrow remains committed to making
TRIESENCE available to U.S. ophthalmologists and retina
specialists.
Mark L. Baum, Chairman and Chief Executive Officer of Harrow,
commented, “We are delighted to confirm the successful completion
of the first of three TRIESENCE PPQ batches. This milestone
resulted from the commitment of teams working in South America,
Europe, and the United States to reinvent the complex manufacturing
and analytical testing process for TRIESENCE. We believe this work
and these results improve our prospects for successfully completing
the balance of the TRIESENCE qualification process and for our
ability to build commercial inventories going forward. Although our
initial TRIESENCE inventory build may not fully meet the expected
demands of the market, we are committed to collaborating closely
with our manufacturing partner to expedite the production of
additional batches as quickly as possible.
“TRIESENCE, a trusted and high-utility solution for
ophthalmologists and retina specialists, has not been easily or
economically replaceable during this lengthy shortage and
out‑of-stock period. Concurrent with our technical team completing
the validation of the TRIESENCE qualification process, Harrow’s
commercial leadership is initiating pre‑commercialization
activities, including discussions with strategic accounts to
pre‑order the expected initial inventory of TRIESENCE.”
If you are an ophthalmologist, retina specialist, or an
institution interested in securing a quantity allocation of
TRIESENCE, please complete the following form for an immediate
supply review.
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical
company engaged in the discovery, development, and
commercialization of innovative ophthalmic pharmaceutical products
for the North American market. Harrow helps eyecare professionals
preserve the gift of sight by making its portfolio of prescription
and non-prescription pharmaceutical products accessible and
affordable to millions of patients each year. For more information
about Harrow, please visit harrow.com.
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; 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, including its Annual Report on
Form 10-K and its Quarterly Reports on Form 10-Q. 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.
About TRIESENCE® (triamcinolone acetonide injectable
suspension) 40 mg/mL:
HIGHLIGHTS OF TRIESENCE PRESCRIBING INFORMATION
INDICATIONS AND USAGE
TRIESENCE suspension is a synthetic corticosteroid indicated
for:
- Treatment of the following ophthalmic diseases: sympathetic
ophthalmia, temporal arteritis, uveitis, and ocular inflammatory
conditions unresponsive to topical corticosteroids.
- Visualization during vitrectomy.
DOSAGE AND ADMINISTRATION
- Initial recommended dose for all indications except
visualization: 4 mg (100 microliters of 40 mg/mL suspension) with
subsequent dosage as needed over the course of treatment.
- Recommended dose for visualization: 1 to 4 mg (25 to 100
microliters of 40 mg/mL suspension) administered
intravitreally.
DOSAGE FORMS AND STRENGTHS
Single use 1 mL vial containing 40 mg/mL of triamcinolone
acetonide suspension.
CONTRAINDICATIONS
- Patients with systemic fungal infections.
- Hypersensitivity to triamcinolone or any component of this
product.
WARNINGS AND PRECAUTIONS
- TRIESENCE suspension should not be administered
intravenously.
- Ophthalmic effects: May include cataracts, infections, and
glaucoma. Monitor intraocular pressure.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression,
Cushing's syndrome and hyperglycemia: Monitor patients for these
conditions and taper doses gradually.
- Infections: Increased susceptibility to new infection and
increased risk of exacerbation, dissemination, or reactivation of
latent infection.
- Elevated blood pressure, salt and water retention, and
hypokalemia: Monitor blood pressure and sodium, potassium serum
levels.
- GI perforation: Increased risk in patients with certain GI
disorders.
- Behavioral and mood disturbances: May include euphoria,
insomnia, mood swings, personality changes, severe depression, and
psychosis.
- Decreases in bone density: Monitor bone density in patients
receiving long-term corticosteroid therapy.
- Live or live attenuated vaccines: Do not administer to patients
receiving immunosuppressive doses of corticosteroids.
- Negative effects on growth and development: Monitor pediatric
patients on long-term corticosteroid therapy.
- Use in pregnancy: Fetal harm can occur with first trimester
use.
- Weight gain: May cause increased appetite.
DRUG INTERACTIONS
- Anticoagulant agents: May enhance or diminish anticoagulant
effects. Monitor coagulation indices.
- Antidiabetic agents: May increase blood glucose concentrations.
Dose adjustments of antidiabetic agents may be required.
- CYP 3A4 inducers and inhibitors: May respectively increase or
decrease clearance of corticosteroids necessitating dose
adjustment.
- Non-steroidal anti-inflammatory drugs (NSAIDs), including
aspirin and salicylates: Increased risk of gastrointestinal side
effects.
For complete product information about TRIESENCE, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f045347-3e5e-4bbd-90f8-6c3100985ca5.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240620854415/en/
Investors Jamie Webb
Director of Communications and Investor Relations
jwebb@harrowinc.com 615-733-4737
Media Deb Holliday Holliday
Communications, Inc. deb@hollidaycommunications.net
412-877-4519
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