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Last Updated: December 22, 2024

PHOTREXA VISCOUS IN DEXTRAN 20% Drug Patent Profile


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When do Photrexa Viscous In Dextran 20% patents expire, and what generic alternatives are available?

Photrexa Viscous In Dextran 20% is a drug marketed by Glaukos and is included in one NDA.

The generic ingredient in PHOTREXA VISCOUS IN DEXTRAN 20% is riboflavin 5'-phosphate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riboflavin 5'-phosphate profile page.

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Summary for PHOTREXA VISCOUS IN DEXTRAN 20%
Drug patent expirations by year for PHOTREXA VISCOUS IN DEXTRAN 20%

US Patents and Regulatory Information for PHOTREXA VISCOUS IN DEXTRAN 20%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaukos PHOTREXA VISCOUS IN DEXTRAN 20% riboflavin 5'-phosphate SOLUTION/DROPS;OPHTHALMIC 203324-002 Apr 15, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHOTREXA VISCOUS IN DEXTRAN 20% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PHOTREXA VISCOUS in Dextran 20%

Introduction to PHOTREXA VISCOUS

PHOTREXA VISCOUS, along with PHOTREXA, are photoenhancers developed by Avedro and approved by the US FDA in 2016 for use with the KXL System in corneal collagen cross-linking. These products are specifically indicated for the treatment of progressive keratoconus and corneal ectasia following refractive surgery[4].

Market Overview of Keratoconus Treatment

The keratoconus treatment market is experiencing significant growth driven by increasing prevalence and awareness of the disease. As of 2021, the global keratoconus market size was valued at approximately USD 3 billion and is anticipated to grow with a substantial Compound Annual Growth Rate (CAGR) during the forecast period from 2019 to 2032[1].

Prevalence of Keratoconus

The diagnosed prevalent population of keratoconus in the seven primary markets (the United States, EU4 countries, the United Kingdom, and Japan) was estimated to be around 1,818,900 in 2021. In the United States alone, there were approximately 743,000 diagnosed cases, while Japan had around 257,600 diagnosed cases[1].

Key Treatments and Market Players

PHOTREXA VISCOUS and PHOTREXA

PHOTREXA VISCOUS and PHOTREXA are crucial components in the treatment of progressive keratoconus. These photoenhancers, when used with the KXL System, facilitate corneal collagen cross-linking, a procedure that strengthens the cornea and halts the progression of keratoconus[3][4].

Dosage and Administration

PHOTREXA VISCOUS is administered as a 3 mL glass syringe containing sterile 1.46 mg/mL riboflavin 5'-phosphate in 20% dextran ophthalmic solution. The treatment involves debriding the epithelium, instilling the solution, and then performing the cross-linking procedure using the KXL System[3][4].

Market Dynamics

Growth Drivers

  • Increasing Prevalence: The rising number of diagnosed keratoconus cases is a significant driver for the market growth.
  • Advanced Diagnostic and Treatment Options: Improved diagnostic techniques and the availability of effective treatments like PHOTREXA VISCOUS are boosting market demand.
  • Awareness and Funding: Increased awareness of keratoconus and growing funding for research and development (R&D) are further propelling the market[1].

Competitive Landscape

The keratoconus treatment market is competitive, with several key players involved. Avedro, the developer of PHOTREXA VISCOUS and PHOTREXA, is a major player. Other companies like Glaukos Corporation, iVeena Delivery Systems, and Ocular Therapeutix are also active in the market, developing various therapeutic candidates and pipeline products[1].

Financial Trajectory

Market Size and Forecast

The global keratoconus treatment market was valued at around USD 322.7 million in 2016 and is expected to reach USD 427.5 million by 2023, growing at a CAGR of 4.1% from 2017 to 2023. By 2021, the market size had already reached approximately USD 3 billion and is anticipated to continue growing significantly until 2032[1].

Revenue from PHOTREXA VISCOUS

While specific revenue figures for PHOTREXA VISCOUS are not provided, the product's approval and inclusion in the treatment regimen for progressive keratoconus contribute significantly to the overall market growth. The success of PHOTREXA VISCOUS is tied to the broader adoption of corneal collagen cross-linking procedures, which are becoming more common due to their efficacy in treating keratoconus.

Pipeline Development and Launches

The launch of various pipeline products and the ongoing development activities in the keratoconus market are expected to revolutionize the market dynamics. Companies are investing heavily in R&D, which will lead to the introduction of new and improved treatments, further driving market growth[1].

Regulatory and Clinical Aspects

FDA Approval

PHOTREXA VISCOUS and PHOTREXA were approved by the FDA in 2016 after a thorough review process that included multiple clinical trials. The approval was granted after addressing several deficiencies and ensuring the safety and efficacy of the products[2][5].

Clinical Efficacy

Clinical studies have demonstrated the efficacy of PHOTREXA VISCOUS and PHOTREXA in treating progressive keratoconus. For instance, studies showed a significant reduction in keratometry readings in the treatment group compared to the control group, indicating the effectiveness of the treatment[5].

Key Takeaways

  • Growing Market: The keratoconus treatment market is expected to grow significantly due to increasing prevalence and awareness.
  • Effective Treatments: PHOTREXA VISCOUS and PHOTREXA are key treatments approved for corneal collagen cross-linking.
  • Competitive Landscape: The market is competitive with several key players involved in developing new therapeutic candidates.
  • Financial Growth: The market size is projected to increase substantially, driven by the adoption of advanced treatments.
  • Regulatory Approval: PHOTREXA VISCOUS and PHOTREXA have been approved by the FDA after rigorous clinical trials.

FAQs

What is PHOTREXA VISCOUS used for?

PHOTREXA VISCOUS is used in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

How is PHOTREXA VISCOUS administered?

PHOTREXA VISCOUS is administered topically in a 3 mL glass syringe containing sterile 1.46 mg/mL riboflavin 5'-phosphate in 20% dextran ophthalmic solution, in conjunction with the KXL System.

What are the key drivers of the keratoconus treatment market?

The key drivers include increasing prevalence, advanced diagnostic and treatment options, and growing awareness and funding for R&D.

Who are the major players in the keratoconus treatment market?

Major players include Avedro, Glaukos Corporation, iVeena Delivery Systems, and Ocular Therapeutix.

What is the projected market size for keratoconus treatment by 2032?

The keratoconus market size is anticipated to grow significantly, with a substantial CAGR during the forecast period from 2019 to 2032, though exact figures for 2032 are not specified.

Sources

  1. Keratoconus Market to Reach New Heights in Growth by 2032, OpenPR.
  2. 203324Orig2s000 - accessdata.fda.gov, FDA.
  3. Photrexa® Viscous & Photrexa® | Prescribing Information - Glaukos, Glaukos.
  4. Photrexa® Viscous & Photrexa® | Prescribing Information - Glaukos, Glaukos.
  5. 203324Orig1s000 | FDA, FDA.

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