Rayner Surgical Company Profile

What is the competitive landscape for RAYNER SURGICAL

RAYNER SURGICAL has one approved drug.

There are three US patents protecting RAYNER SURGICAL drugs.

There are fifty patent family members on RAYNER SURGICAL drugs in thirty-seven countries and nine supplementary protection certificates in eight countries.

Summary for Rayner Surgical

International Patents:	50
US Patents:	3
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Rayner Surgical

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,855,246		Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,066,856*PED				Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,486,406*PED				Y

Expired US Patents for Rayner Surgical

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,278,101*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	8,173,707*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	8,586,633*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,399,040*PED

Paragraph IV (Patent) Challenges for RAYNER SURGICAL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	1%/0.3%		2015-05-29

International Patents for Rayner Surgical Drugs

Country	Patent Number	Estimated Expiration
China	104822265
Japan	2015535250
Japan	2019081798
Malaysia	188474
Serbia	62188
South Korea	20200000487
South Korea	20210018954

Supplementary Protection Certificates for Rayner Surgical Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Rayner Surgical

Pharmaceutical Competitive Landscape Analysis: Rayner Surgical – Market Position, Strengths & Strategic Insights

In the dynamic world of ophthalmology, Rayner Surgical Group has emerged as a significant player, carving out a niche for itself with innovative products and strategic moves. This analysis delves into Rayner's market position, strengths, and strategic insights, offering a comprehensive view of the company's competitive landscape.

Rayner's Market Position

Rayner Surgical Group, a pioneer in ophthalmic implants and pharmaceuticals, has a rich history dating back to 1949 when Sir Harold Ridley chose the company to manufacture the world's first intraocular lens (IOL)[5]. This legacy has positioned Rayner as a trusted name in the ophthalmology sector, particularly in cataract surgery solutions.

Global Presence and Expansion

Rayner has been steadily expanding its global footprint, with a particular focus on key markets:

1. United States: In 2017, Rayner established a dedicated subsidiary, Rayner Surgical Inc., based in New York[5]. This move strengthened the company's commitment to the US market, which is the largest IOL market globally with over four million cataract procedures forecast for 2017.

2. Canada: In 2021, Rayner announced its direct entry into the Canadian ophthalmology market through Rayner Surgical Corp[9]. This expansion is significant given that Canada has the highest cataract surgery rate in the world at 14.6 per thousand.

3. Europe: The company has been focusing on European expansion, with notable growth in countries like Spain and Italy, where business has grown over 400% year on year[5].

Product Portfolio and Innovation

Rayner's product portfolio is centered around ophthalmic solutions, with a strong focus on intraocular lenses and related technologies.

Intraocular Lenses (IOLs)

Rayner offers a comprehensive range of IOLs, including:

• RayOne Aspheric fully preloaded monofocal IOL
• RayOne EMV premium monofocal IOL
• RayOne Hydrophobic aspheric monofocal IOL
• RayOne Spheric monofocal IOL
• RayOne Toric IOL
• RayOne Trifocal IOL
• RayOne Trifocal Toric IOL[9]

The company's latest lens platform, the 600C, received FDA approval and was launched in the USA in 2018 in both manual and preloaded formats[5].

Milestone Achievements

Rayner recently celebrated a significant milestone with the implantation of its 4 millionth RayOne IOL[2]. This achievement underscores the global impact and adoption of Rayner's technology in ophthalmic surgery.

"Given the rapid growth of the RayOne platform and RayOne EMV in particular, I can see that we are just at the beginning of the success of this fantastic surgical option for cataract patients," elaborated Dr. Radcliffe[2].

Digital Health Initiatives

Rayner is also making strides in digital health, partnering with Wolffsohn Research Ltd. to develop its Digital Health platform[7]. This initiative includes enhancing RayPRO, a free contactless telehealth solution that collects Patient Reported Outcomes (PROs) after cataract surgery.

Strategic Acquisitions and Partnerships

Rayner has been actively pursuing strategic acquisitions and partnerships to strengthen its market position and expand its product offerings.

Acquisition of Omidria

In December 2021, Rayner acquired Omeros Corporation's ophthalmology assets, including Omidria[3]. This acquisition is significant for several reasons:

1. It enables Rayner to create a substantial commercial, regulatory, and marketing infrastructure in the US.
2. Omidria, the acquired product, has excellent clinical data supporting the maintenance of mydriasis during surgery, protection from cystoid macular oedema, and reduction of post-operative pain without opioids.
3. The acquisition aligns with Rayner's strategic focus on visual outcomes and patient safety.

Partnership with Wolffsohn Research

In February 2022, Rayner announced a development partnership with Wolffsohn Research Ltd. to extend its digital health leadership[7]. This partnership aims to:

1. Further develop Rayner's Digital Health platform
2. Enhance RayPRO to improve user experiences
3. Develop new products, including applications to digitally support patients' use of AEON, Rayner's eye drop family designed for use before and after cataract surgery

Manufacturing and Innovation Capabilities

Rayner has invested significantly in its manufacturing and innovation capabilities to support its growth strategy.

The Ridley Innovation Centre

Rayner's move to The Ridley Innovation Centre has tripled its production capacity[5]. This increased capacity supports the company's ambitious plans to expand its direct business on a global scale.

Research and Development

Rayner maintains a robust pipeline of research and development projects, positioning the company to introduce additional groundbreaking IOLs in the coming years[2].

Market Recognition and Performance

Rayner's performance and innovation have not gone unnoticed in the industry.

Top Performing Mid-Market Company

Rayner has been recognized as one of the top-performing mid-market companies in Sussex, UK[6]. This recognition underscores the company's strong financial performance and growth trajectory.

Industry Leadership

Rayner's CEO, Tim Clover, has emphasized the company's ambitious growth strategy:

"The investment in our US subsidiary marks a significant achievement in Rayner's ambitious growth strategy and we will continue to work hard in providing the US market with access to existing products as well as products in our pipeline, all with the ambition of delivering better patient outcomes."[5]

Competitive Advantages

Rayner's competitive advantages stem from several key factors:

1. Historical Legacy: As the manufacturer of the world's first IOL, Rayner has a unique historical position in the ophthalmology market.

2. Innovation Focus: The company's continuous investment in R&D and new product development keeps it at the forefront of ophthalmic technology.

3. Global Expansion: Strategic moves into key markets like the US and Canada have strengthened Rayner's global presence.

4. Comprehensive Product Portfolio: Rayner offers a wide range of IOLs and related products, catering to various patient needs.

5. Digital Health Initiatives: The company's focus on digital health solutions sets it apart in an increasingly technology-driven healthcare landscape.

6. Strategic Acquisitions: Acquisitions like Omidria have expanded Rayner's product offerings and market reach.

7. Manufacturing Capacity: The tripled production capacity at The Ridley Innovation Centre supports Rayner's growth ambitions.

Challenges and Future Outlook

Despite its strong position, Rayner faces several challenges in the competitive ophthalmology market:

1. Intense Competition: The ophthalmology market, particularly for IOLs, is highly competitive with several established players.

2. Regulatory Hurdles: As a medical device manufacturer, Rayner must navigate complex regulatory environments across different markets.

3. Technological Advancements: Rapid technological changes in ophthalmology require continuous innovation and adaptation.

4. Market Dynamics: Changes in healthcare systems, reimbursement policies, and patient preferences can impact demand for Rayner's products.

Looking ahead, Rayner's future outlook appears promising. The company's focus on innovation, strategic expansions, and digital health initiatives position it well for continued growth in the ophthalmology market.

Key Takeaways

1. Rayner Surgical Group has a strong historical legacy in ophthalmology, being the manufacturer of the world's first IOL.
2. The company has been expanding globally, with significant moves into the US and Canadian markets.
3. Rayner's product portfolio is comprehensive, focusing on innovative IOLs and related technologies.
4. Strategic acquisitions, such as Omidria, have strengthened Rayner's market position.
5. The company is investing in digital health initiatives, partnering with Wolffsohn Research to enhance its offerings.
6. Rayner's tripled production capacity at The Ridley Innovation Centre supports its ambitious growth plans.
7. The company faces challenges from intense competition and regulatory hurdles but is well-positioned for future growth in the ophthalmology market.

FAQs

1. What is Rayner Surgical Group's main focus in ophthalmology? Rayner primarily focuses on developing and manufacturing intraocular lenses (IOLs) and related technologies for cataract surgery.

2. How has Rayner expanded its global presence recently? Rayner has established a dedicated subsidiary in the US (Rayner Surgical Inc.) and entered the Canadian market directly through Rayner Surgical Corp.

3. What is the significance of Rayner's acquisition of Omidria? The acquisition of Omidria from Omeros Corporation expanded Rayner's product portfolio and strengthened its presence in the US market.

4. How is Rayner investing in digital health? Rayner has partnered with Wolffsohn Research Ltd. to develop its Digital Health platform, including enhancements to RayPRO, a telehealth solution for collecting Patient Reported Outcomes after cataract surgery.

5. What sets Rayner apart from its competitors in the ophthalmology market? Rayner's historical legacy as the manufacturer of the first IOL, combined with its focus on innovation, comprehensive product portfolio, and strategic global expansion, gives it a unique position in the market.

Sources cited:

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7. [9]