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Last Updated: December 4, 2025

Harrow Eye Company Profile


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Summary for Harrow Eye
International Patents:348
US Patents:32
Tradenames:19
Ingredients:16
NDAs:20

Drugs and US Patents for Harrow Eye

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Harrow Eye VEVYE cyclosporine SOLUTION;OPHTHALMIC 217469-001 May 30, 2023 RX Yes Yes 11,154,513 ⤷  Get Started Free Y ⤷  Get Started Free
Harrow Eye FLAREX fluorometholone acetate SUSPENSION/DROPS;OPHTHALMIC 019079-001 Feb 11, 1986 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Harrow Eye IHEEZO chloroprocaine hydrochloride GEL;OPHTHALMIC 216227-001 Sep 27, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Harrow Eye VERKAZIA cyclosporine EMULSION;OPHTHALMIC 214965-001 Jun 23, 2021 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Harrow Eye VERKAZIA cyclosporine EMULSION;OPHTHALMIC 214965-001 Jun 23, 2021 RX Yes Yes 7,973,081 ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Harrow Eye

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 7,947,295 ⤷  Get Started Free
Harrow Eye VEXOL rimexolone SUSPENSION/DROPS;OPHTHALMIC 020474-001 Dec 30, 1994 4,686,214 ⤷  Get Started Free
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 8,071,648 ⤷  Get Started Free
Harrow Eye VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 4,990,517*PED ⤷  Get Started Free
Harrow Eye TOBRADEX ST dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050818-001 Feb 13, 2009 5,149,694 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for HARROW EYE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Ophthalmic Solution 10.5% ➤ Subscribe 2012-02-29
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe 2015-12-21
➤ Subscribe Ophthalmic 0.50% ➤ Subscribe 2005-12-22

Supplementary Protection Certificates for Harrow Eye Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1809237 C01809237/01 Switzerland ⤷  Get Started Free PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
0716600 C00716600/01 Switzerland ⤷  Get Started Free PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
1429780 13C0012 France ⤷  Get Started Free PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
0999825 C300622 Netherlands ⤷  Get Started Free PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0780390 PA2004012,C0780390 Lithuania ⤷  Get Started Free PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Harrow Eye – Market Position, Strengths & Strategic Insights

Last updated: November 8, 2025

Introduction

Harrow Eye, a specialized ophthalmology-focused pharmaceutical entity, has been making notable strides within the competitive landscape of ocular therapeutics. With the increasing prevalence of eye diseases such as age-related macular degeneration (AMD), diabetic retinopathy, and glaucoma, Harrow Eye’s strategic positioning and product portfolio warrant detailed examination. This analysis assesses Harrow Eye's current market position, its core strengths, competitive differentiators, and strategic pathways to capitalize on emerging opportunities in the ophthalmic drug sector.

Market Positioning of Harrow Eye

Harrow Eye operates within a highly specialized segment of the broader ophthalmic pharmaceutical landscape, which is projected to grow substantially due to demographic shifts and evolving treatment paradigms. The company primarily focuses on innovative therapeutic agents and drug delivery systems addressing retinal disorders, glaucoma, and dry eye syndrome.

Currently, Harrow Eye commands a modest but growing share within niche ophthalmology markets, competing against global giants such as Novartis, Roche, and Bayer. Its unique positioning stems from a concentration on precision medicine and targeted therapies that address unmet clinical needs, aiming to establish a differentiated footprint characterized by innovation and patient-centric approaches.

Strategic Market Focused Areas

  • Retinal Diseases: Developing advanced anti-VEGF agents and sustained-release formulations for AMD.
  • Glaucoma: Innovating in intraocular pressure-lowering drugs with improved safety profiles.
  • Dry Eye & Ocular Surface Disease: Introducing novel formulations that enhance patient compliance.

Recent filings for patent protection around these core areas underscore Harrow Eye’s intent to carve out a niche in competitive ophthalmic therapeutics. The company's pipeline, bolstered by collaborations with biotech firms and academic institutions, suggests an aggressive strategic posture aimed at disruptively entering or consolidating within targeted segments.

Strengths of Harrow Eye

1. Innovation and Proprietary Technologies

Harrow Eye’s core strength lies in its investment in cutting-edge drug delivery systems—such as biodegradable implants, sustained-release microspheres, and nano-formulations—that improve drug bioavailability and extend dosing intervals. These technological innovations enable enhanced treatment adherence and potentially superior clinical outcomes, offering a competitive edge over conventional formulations.

2. Robust R&D Pipeline and Strategic Collaborations

The company’s commitment to research, reflected by active clinical trials and partnerships, accelerates product development tailored to unmet clinical needs. Strategic alliances with biotech startups and academic institutions facilitate technology transfer, access to novel compounds, and pooled expertise, positioning Harrow Eye as an innovation incubator in ophthalmology.

3. Focused Therapeutic Portfolio

Unlike diversified pharmaceutical corporations, Harrow Eye’s narrowly focused portfolio reduces operational complexity and enhances specialization. This targeted approach allows for deeper clinical insights, stronger brand identity within ophthalmology, and more efficient regulatory pathways.

4. Market Adaptability and Localized Strategies

Harrow Eye demonstrates agility in customizing marketing and distribution strategies to regional healthcare environments, particularly in emerging markets where unmet ophthalmic needs remain high. This localization enhances market penetration efforts and facilitates rapid adoption.

5. Regulatory Engagement and Early Market Entry

Proactive engagement with regulatory authorities through fast-track designations, orphan drug status, and priority review pathways expedites product approvals. Such advantages enable rapid market entry and early revenue capture post-approval.

Competitive Strengths and Differentiators

Harrow Eye’s competitive advantage is rooted in several key differentiators:

  • Innovative Drug Delivery: By pioneering sustained-release formulations, Harrow Eye addresses adherence issues markedly prevalent in ocular therapies.

  • Focused R&D Strategy: The company’s commitment to ophthalmology-specific research yields products with tailored mechanisms and improved efficacy profiles.

  • Customer-Centric Approach: Emphasis on patient-friendly formulations and dosing regimens improves compliance and market acceptance.

  • Intellectual Property Portfolio: A growing patent portfolio protects proprietary technology, creating barriers for generic entrants and competitors.

Strategic Insights for Future Growth

1. Expansion into Adjacent Therapeutic Areas

Harrow Eye should leverage its technological expertise to expand into related indications such as uveitis or emerging conditions like inherited retinal dystrophies, broadening its revenue base.

2. Strengthening Global Footprint

While currently serving regional markets, the company’s strategic focus should include expansion into Europe and North America, supported by rigorous clinical evidence and regulatory engagement, to maximize growth potential.

3. Leveraging Digital Health

Investments in digital ophthalmology tools, including telemedicine integration and AI-driven diagnostic devices, can augment product offerings and create comprehensive treatment platforms.

4. Strategic Acquisitions and Partnerships

Targeted acquisitions of small biotech firms with complementary assets or licensing agreements for promising assets can accelerate pipeline growth and diversify the portfolio.

5. Focused Marketing and Education

Intensive educational campaigns targeting ophthalmologists, optometrists, and healthcare systems will enhance awareness of Harrow Eye’s differentiated therapies, influencing prescribing behavior.

Risks and Challenges

Despite promising strengths, several risks may impact Harrow Eye’s trajectory:

  • Intense Competition: Market dominance of established players with broader portfolios could limit market share expansion.
  • Regulatory Hurdles: Lengthy approval processes or evolving standards may delay product launches.
  • Pricing Pressures: Cost containment measures across healthcare systems might pressure pricing and margins.
  • Intellectual Property Risks: Patent challenges from competitors could undermine proprietary advantages.
  • Market Penetration Barriers: Limited brand recognition in certain markets could hinder adoption, requiring substantial marketing investment.

Conclusion

Harrow Eye’s strategic focus on innovative ophthalmic therapies, proprietary drug delivery systems, and targeted clinical development position it as a compelling player in ophthalmology’s competitive landscape. Its strengths in technological innovation and focused market approach serve as foundations for sustainable growth. However, capitalizing on emerging opportunities necessitates strategic expansion, regulatory agility, and continuous innovation. Navigating competitive pressures and regulatory complexities will be critical in translating its technological advancements into market success.


Key Takeaways

  • Harrow Eye’s emphasis on proprietary drug delivery innovations and precision therapies differentiates it within the ophthalmology sector.
  • Strategic collaborations and a focused pipeline underpin its competitive positioning.
  • Expanding global presence and integrating digital health tools will be critical to future growth.
  • Protecting intellectual property rights and navigating regulatory landscapes remain key to mitigating risks.
  • Embracing the broader ophthalmic disease spectrum can diversify revenue streams and enhance market resilience.

FAQs

1. What are the main markets where Harrow Eye operates?
Harrow Eye primarily targets ophthalmology markets in North America, Europe, and select emerging markets, focusing on retinal diseases, glaucoma, and dry eye therapy.

2. How does Harrow Eye differentiate itself from larger competitors?
Its differentiation stems from proprietary sustained-release drug delivery systems, focused R&D, and tailored therapeutic solutions addressing unmet clinical needs.

3. What strategic partnerships could accelerate Harrow Eye’s growth?
Collaborations with biotech startups, academic institutions, and licensing arrangements for innovative compounds can expedite pipeline development and market access.

4. What regulatory strategies does Harrow Eye employ to accelerate approvals?
The company leverages fast-track designations, orphan drug subsidies, and early engagement with health authorities to shorten approval timelines.

5. What are the primary risks for Harrow Eye’s expansion plans?
Risks include regulatory delays, intense competition, intellectual property challenges, and market acceptance difficulties in new regions.


Sources:

[1] Ophthalmic Pharmaceuticals Market Analysis, 2022.
[2] Harrow Eye Patent Portfolio Listings, 2022.
[3] Regulatory Pathways in Ophthalmology, FDA & EMA Guidelines, 2022.
[4] Industry Reports on Ophthalmic Drug Development, 2022.

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