Harrow Enters into 340B Prime Vendor Program Contract with Apexus™ for IHEEZO® and Other Key Harrow Products
Contract Enhances Purchasing Power for 340B Prime Vendor Program (PVP) Participants; Aligns with Harrow’s Mission to Make Its Products Accessible and Affordable
In commenting on the agreement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We believe the value this agreement provides to eligible participants will open access to IHEEZO for the
The 340B Prime Vendor Program, managed by Apexus, is a contract awarded by the Health Resources and Services Administration (“HRSA”), an agency of the
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
About IHEEZO® (chloroprocaine hydrochloride ophthalmic gel)
- IHEEZO is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.
- IHEEZO was approved by the FDA on September 26, 2022.
- Clinical trials of IHEEZO demonstrated that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure.
-
IHEEZO represents the first approved use in the
U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for theU.S. ophthalmic market in nearly 14 years. - IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.
INDICATIONS AND USAGE
IHEEZO™ is indicated for ocular surface anesthesia.
CONTRAINDICATIONS
IHEEZO™ is contraindicated in patients with a history of hypersensitivity to any component of this preparation.
WARNINGS AND PRECAUTIONS
IHEEZO™ should not be injected or intraocularly administered. Patients should not touch the eye for at least 10 to 20 minutes after using an anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip to any surface as this may contaminate the gel. IHEEZO™ is indicated for administration under the direct supervision of a healthcare provider. IHEEZO™ is not intended for patient self-administration.
ADVERSE REACTIONS
The most common adverse reaction is mydriasis (approximately
For complete product information about IHEEZO®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3b2d2c-8b33-d199-e053-2995a90a699c.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution)
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.
*Efficacy for this organism was studied in fewer than 10 infections.
IMPORTANT SAFETY INFORMATION
Contraindications
VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warnings and Precautions
- Hypersensitivity Reactions – Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
- Prolonged Use – May result in overgrowth of non-susceptible organisms, including fungi.
- Avoid Contact Lens Wear – Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Adverse Reactions
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately
Nonocular adverse events reported at a rate of
For complete product information about VIGAMOX®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062.
About ILEVRO® (nepafenac ophthalmic suspension)
ILEVRO® (nepafenac ophthalmic suspension)
INDICATIONS AND USAGE
ILEVRO®
CONTRAINDICATIONS
ILEVRO®
WARNINGS AND PRECAUTIONS
Increased Bleeding Time. With some NSAIDs including ILEVRO®
Delayed Healing. Topical NSAIDs including ILEVRO®
Corneal Effects. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including ILEVRO®
Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events.
Contact Lens Wear. ILEVRO®
ADVERSE REACTIONS
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Serious and Otherwise Important Adverse Reactions. The following adverse reactions are discussed in greater detail in other sections of labeling: (1) Increased Bleeding Time, (2) Delayed Healing and (3) Corneal Effects.
Ocular Adverse Reactions. The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to
Non-Ocular Adverse Reactions. Non-ocular adverse reactions reported at an incidence of 1 to
For complete product information about ILEVRO®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10f411d3-a81e-074a-e063-6294a90ab547.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240709623740/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
Source: Harrow, Inc.