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Sydnexis

Full company profile

uuid0000et2

Namestring
Sydnexis
Legal namestring
Sydnexis, Inc.
Websiteurl
sydnexis.com
Company typeenum
Private
Founded yearint
2014
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersDel Mar, United States
HQ citystring
Del Mar
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
pediatric ophthalmic pharmaceuticals, low-dose atropine formulation, myopia management therapy, ophthalmic biopharmaceuticals, prescription eye drop development
Industry2 codes
PRIMARYHLAIAIAK
Rare Ophthalmology Disorder Therapies
Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals
SECONDARYHLAIAIAN
Rare Pediatric & Congenital Disorder Therapies
Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals
NAICS code1 code
  • Scientific Research and Development Services5417
SIC code1 code
  • Pharmaceutical Preparations2834
Product category
Pediatric Ophthalmic Pharmaceuticals
Social media profiles1 record
GTM motion2 records

Each record includes

Type, Description, Source

Revenue model2 records
1Licensing Royalties (Santen Partnership)
TypeLicensing Royalties
Description

Sydnexis licenses SYD-101 to Santen S.A. for commercialization in Europe, the Middle East, and Africa under the brand name Ryjunea®. The company receives royalty payments from Santen's sales in these territories. Approvals have been obtained in the EU and UK, with initial launch in Germany.

sydnexis.com
2Pharmaceutical Product Sales (US Market)
TypeOne Time License
Description

Upon FDA approval, Sydnexis intends to commercialize SYD-101 directly in the US market as the first and only FDA-approved pharmaceutical treatment for pediatric progressive myopia for children ages 3-14.

sydnexis.com
Marketing channels5 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels2 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Technology or R&D, Personnel, Operations, Marketing or Sales, Others
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Sydnexis develops SYD-101, a proprietary low-dose atropine 0.01% eye drop formulation designed to slow the progression of pediatric progressive myopia in children aged 3-14. The compound features near-neutral pH, enhanced ocular tissue permeability, BAK preservation, and 3-year room temperature stability. SYD-101 is approved in the EU and UK (marketed as Ryjunea®) through licensing partner Santen S.A., and is under FDA review for the US market.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 4 values shown
  • 47.9% reduction in myopia progression at 12 months in children aged 3-12
+3 more records
Product overview1 text field

Sydnexis is a biopharmaceutical company developing a single lead product candidate, SYD-101, which is a proprietary low-dose atropine 0.01% eye drop for treating pediatric progressive myopia. The product is administered once nightly and is being studied for use in children as young as 3 years old. SYD-101 features novel formulation attributes including near-neutral pH for tolerability, enhanced ocular tissue permeability, and room-temperature stability. The product is currently approved in the European Union and UK under the brand name Ryjunea® through licensing partner Santen S.A., and is under regulatory review for FDA approval in the United States where it would represent the first FDA-approved pharmaceutical treatment for pediatric progressive myopia.

Product and service1 record
1SYD-101
CategoryPediatric Ophthalmic Pharmaceuticals
Description

SYD-101 is Sydnexis's proprietary investigational low-dose atropine 0.01% eye drop formulation intended to slow the progression of pediatric progressive myopia in children aged 3-14. The formulation features near-neutral pH for ocular tolerability, enhanced ocular tissue permeability demonstrated in preclinical models, BAK preservation for sustained bioavailability, and stability for up to 3 years at room temperature. It is administered once nightly and was studied in the Phase 3 STAR trial, the largest global clinical program in pediatric myopia enrolling 852 children across 47 sites in the US and Europe.

Scale indicator5 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
Strategic tierCoreTypeOEM/ Whitelabel/ Licensing PartnerAnnounced on2021-01-01
Description

Sydnexis licensed SYD-101 to Santen S.A. for commercialization in Europe, the Middle East, and Africa. Santen commercializes the product under the brand name Ryjunea® (low-dose atropine 0.1 mg/ml). This partnership followed the 2021 Series B financing and represents the company's primary international commercialization strategy.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Late-stage clinical biopharma developing NVK002, a low-dose atropine formulation for pediatric myopia progression. Directly competes with SYD-101 in the same indication, patient population, and regulatory pathway.

TypeDirect peer
Description

Ophthalmic pharma developing pediatric myopia therapies (including MicroPine) using its proprietary Optejet delivery platform. Directly competes in the PPM pharmaceutical space with a differentiated delivery technology.

TypeEmerging player
Description

Asia-focused ophthalmic biotech developing ARVN302, a low-dose atropine for myopia. Operates in the same therapeutic category and uses a similar regulatory strategy, but primary focus is on the Greater China market.

TypeBroad incumbent
Description

Large contact lens manufacturer whose MiSight 1 day is the first FDA-approved product for myopia progression control. Competes with SYD-101 in the same PPM indication via a non-pharmaceutical specialty contact lens modality.

TypeBroad incumbent
Description

Major ophthalmic pharma and device company with broad pediatric vision care offerings. Represents a potential strategic acquirer and competitor across multiple PPM management modalities including lenses and emerging pharmacotherapies.

TypeBroad incumbent
Description

Japanese ophthalmic specialty pharma and Sydnexis's EU/Middle East/Africa licensing partner for Ryjunea®. A leading global ophthalmic player with deep myopia presence, particularly across Asia and Europe.

TypeEmerging player
Description

Ophthalmic biopharma developing sustained-release therapies for anterior segment diseases. Comparable as a small-cap, late-clinical ophthalmic biotech pursuing regulatory and commercial milestones in eye care.

TypeBroad incumbent
Description

Global leader in eye care with broad surgical and vision care franchises. Competes with Sydnexis in pediatric vision care via specialty lenses and is a potential strategic acquirer for emerging ophthalmic pharma assets.

TypeBroad incumbent
Description

Global biopharma with a significant ophthalmology franchise inherited from Allergan. Operates in adjacent retinal and anterior segment categories and is a potential strategic acquirer of PPM assets.

TypeEmerging player
Description

US-focused ophthalmic specialty pharma commercializing branded anterior segment and surface disease therapies. Comparable as a small-cap ophthalmic pharma pursuing niche regulatory and commercial opportunities.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment3 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature4 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles16 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds2 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors6 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Sydnexis

Pediatric Ophthalmic Pharmaceuticalssydnexis.com

Sydnexis firmographics

Firmographics
Name
Sydnexis
Legal name
Sydnexis, Inc.
Website
https://sydnexis.com
Company type
Private
Founded year
2014
Operating status
Operating
Headcount range
11–50 employees
Ownership category
akta.pro rank

Sydnexis industry classification

Industry
Product category
Pediatric Ophthalmic Pharmaceuticals
NAICS
Scientific Research and Development Services (5417)
SIC
Pharmaceutical Preparations (2834)
akta.pro industry
PRIMARYHLAIAIAK
Rare Ophthalmology Disorder Therapies
Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals
SECONDARYHLAIAIAN
Rare Pediatric & Congenital Disorder Therapies
Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals

Keywords

  • Pediatric ophthalmic pharmaceuticals
  • Low-dose atropine formulation
  • Myopia management therapy
  • Ophthalmic biopharmaceuticals
  • Prescription eye drop development

Where Sydnexis is headquartered

Location

Headquarters

HQ city
Del Mar
HQ country
United States
HQ region
North America

Offices1 record

Markets served

Sydnexis business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

  1. Licensing Royalties (Santen Partnership): Sydnexis licenses SYD-101 to Santen S.A. for commercialization in Europe, the Middle East, and Africa under the brand name Ryjunea®. The company receives royalty payments from Santen's sales in these territories. Approvals have been obtained in the EU and UK, with initial launch in Germany.
  2. Pharmaceutical Product Sales (US Market): Upon FDA approval, Sydnexis intends to commercialize SYD-101 directly in the US market as the first and only FDA-approved pharmaceutical treatment for pediatric progressive myopia for children ages 3-14.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Sydnexis product offering

Product offering

Core offering

Sydnexis develops SYD-101, a proprietary low-dose atropine 0.01% eye drop formulation designed to slow the progression of pediatric progressive myopia in children aged 3-14. The compound features near-neutral pH, enhanced ocular tissue permeability, BAK preservation, and 3-year room temperature stability. SYD-101 is approved in the EU and UK (marketed as Ryjunea®) through licensing partner Santen S.A., and is under FDA review for the US market.

Product overview

Sydnexis is a biopharmaceutical company developing a single lead product candidate, SYD-101, which is a proprietary low-dose atropine 0.01% eye drop for treating pediatric progressive myopia. The product is administered once nightly and is being studied for use in children as young as 3 years old. SYD-101 features novel formulation attributes including near-neutral pH for tolerability, enhanced ocular tissue permeability, and room-temperature stability. The product is currently approved in the European Union and UK under the brand name Ryjunea® through licensing partner Santen S.A., and is under regulatory review for FDA approval in the United States where it would represent the first FDA-approved pharmaceutical treatment for pediatric progressive myopia.

Differentiator

Problem solved

Functional benefit

Products and services

  • SYD-101 SYD-101 is Sydnexis's proprietary investigational low-dose atropine 0.01% eye drop formulation intended to slow the progression of pediatric progressive myopia in children aged 3-14. The formulation features near-neutral pH for ocular tolerability, enhanced ocular tissue permeability demonstrated in preclinical models, BAK preservation for sustained bioavailability, and stability for up to 3 years at room temperature. It is administered once nightly and was studied in the Phase 3 STAR trial, the largest global clinical program in pediatric myopia enrolling 852 children across 47 sites in the US and Europe.

Quantifiable outcome

  • 47.9% reduction in myopia progression at 12 months in children aged 3-12
  • +3 more outcomes

Companies that use Sydnexis

Customer profile

Segments3 records

Ideal customer profiles1 record

Sydnexis technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature4 records

Sydnexis partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • Santen S.A.coreOEM/ Whitelabel/ Licensing Partner · 1 January 2021Sydnexis licensed SYD-101 to Santen S.A. for commercialization in Europe, the Middle East, and Africa. Santen commercializes the product under the brand name Ryjunea® (low-dose atropine 0.1 mg/ml). This partnership followed the 2021 Series B financing and represents the company's primary international commercialization strategy.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Sydnexis competitors and assessment

Company assessment

Direct peers

  • Vyluma: Late-stage clinical biopharma developing NVK002, a low-dose atropine formulation for pediatric myopia progression. Directly competes with SYD-101 in the same indication, patient population, and regulatory pathway.
  • Eyenovia: Ophthalmic pharma developing pediatric myopia therapies (including MicroPine) using its proprietary Optejet delivery platform. Directly competes in the PPM pharmaceutical space with a differentiated delivery technology.

Emerging players

  • Arctic Vision: Asia-focused ophthalmic biotech developing ARVN302, a low-dose atropine for myopia. Operates in the same therapeutic category and uses a similar regulatory strategy, but primary focus is on the Greater China market.
  • Ocular Therapeutix: Ophthalmic biopharma developing sustained-release therapies for anterior segment diseases. Comparable as a small-cap, late-clinical ophthalmic biotech pursuing regulatory and commercial milestones in eye care.
  • Harrow Health: US-focused ophthalmic specialty pharma commercializing branded anterior segment and surface disease therapies. Comparable as a small-cap ophthalmic pharma pursuing niche regulatory and commercial opportunities.

Broad incumbents

  • CooperVision (MiSight): Large contact lens manufacturer whose MiSight 1 day is the first FDA-approved product for myopia progression control. Competes with SYD-101 in the same PPM indication via a non-pharmaceutical specialty contact lens modality.
  • Bausch + Lomb: Major ophthalmic pharma and device company with broad pediatric vision care offerings. Represents a potential strategic acquirer and competitor across multiple PPM management modalities including lenses and emerging pharmacotherapies.
  • Santen Pharmaceutical: Japanese ophthalmic specialty pharma and Sydnexis's EU/Middle East/Africa licensing partner for Ryjunea®. A leading global ophthalmic player with deep myopia presence, particularly across Asia and Europe.
  • Alcon: Global leader in eye care with broad surgical and vision care franchises. Competes with Sydnexis in pediatric vision care via specialty lenses and is a potential strategic acquirer for emerging ophthalmic pharma assets.
  • AbbVie (Allergan Aesthetics / Eye Care): Global biopharma with a significant ophthalmology franchise inherited from Allergan. Operates in adjacent retinal and anterior segment categories and is a potential strategic acquirer of PPM assets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Sydnexis social profiles

Digital presence

Sydnexis financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Sydnexis leadership team

Management profile

Number of profiles

Profiles16 records

Sydnexis funding detail

Funding detail

Funding overview

Funding rounds2 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Sydnexis M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sydnexis

What does Sydnexis do?

Sydnexis develops SYD-101, a proprietary low-dose atropine 0.01% eye drop formulation designed to slow the progression of pediatric progressive myopia in children aged 3-14. The compound features near-neutral pH, enhanced ocular tissue permeability, BAK preservation, and 3-year room temperature stability. SYD-101 is approved in the EU and UK (marketed as Ryjunea®) through licensing partner Santen S.A., and is under FDA review for the US market.

Is Sydnexis a public or private company?

Sydnexis is a private company. It is classified as venture growth investor backed and is currently operating.

When was Sydnexis founded?

Sydnexis was founded in 2014. It employs 11 to 50 people.

Where is Sydnexis based?

Sydnexis is headquartered in Del Mar, United States, in the North America region.

How does Sydnexis make money?

Two revenue lines are on record. Licensing Royalties (Santen Partnership) is the primary driver. The others are pharmaceutical Product Sales (US Market).

Who are Sydnexis's main competitors?

Direct peers on record are Vyluma and Eyenovia. Emerging players are Arctic Vision, Ocular Therapeutix and Harrow Health. Broad incumbents are CooperVision (MiSight), Bausch + Lomb, Santen Pharmaceutical, Alcon and AbbVie (Allergan Aesthetics / Eye Care).

Does Sydnexis have an API?

No public API is recorded for Sydnexis.

What industry is Sydnexis in?

Sydnexis's product category is Pediatric Ophthalmic Pharmaceuticals. Its primary akta.pro industry code is HLAIAIAK, Rare Ophthalmology Disorder Therapies, with a secondary code of HLAIAIAN, Rare Pediatric & Congenital Disorder Therapies. Its NAICS code is 5417 and its SIC code is 2834.

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Live signals
BioSpaceSydnexis Announces FDA Advisory Committee Meeting Date to Review NDA for SYD-101 for Pediatric Progressive MyopiaSydnexis announced the FDA will hold an advisory committee meeting on October 30, 2026, to review its NDA for SYD-101, a low-dose atropine for pediatric progressive myopia. The Phase 3 STAR trial met its prespecified primary and key secondary endpoints, with SYD-101 0.01% showing reduced progression and no new safety signals through Month 48.The Pharma LetterSydnexis sells Ryjunea EMEA royalty rights to Ligand for $23 million upfrontSydnexis agreed to sell its royalty rights on net sales of Ryjunea in Europe, the Middle East, and Africa to Ligand Pharmaceuticals for a $23 million upfront payment. Ligand acquires a 100% interest in certain payments under Sydnexis' existing license with Santen Pharmaceutical, which holds commercial rights to the drug in those regions.BioSpaceSydnexis Announces Royalty Agreement with Ligand for Ryjunea®Sydnexis announced an agreement with Ligand to sell royalty rights to Ryjunea in EMEA for $23 million upfront. The company retains U.S. rights and plans to advance SYD-101 through U.S. regulatory review, with potential commercialization in 2027.Ophthalmology TimesFDA issues Complete Response Letter to Sydnexis for SYD-101 pediatric myopia treatmentThe FDA issued a Complete Response Letter to Sydnexis regarding its new drug application for SYD-101, citing insufficient evidence of effectiveness despite the Phase 3 STAR trial achieving primary efficacy goals. Although the agency found no safety or quality deficiencies, it concluded that the data did not sufficiently demonstrate the treatment's effectiveness for pediatric myopia. This decision delays the potential launch of the first FDA-approved pharmaceutical option for this condition in the United States, contrasting with its prior approval in the European Union.Optometry TimesSYD-101's CRL: A shifting of FDA goalpostsOn October 23, 2025, the FDA issued a complete response letter to Sydnexis regarding its new drug application for SYD-101, rejecting the approval despite the STAR trial meeting its primary endpoint due to insufficient demonstration of clinical meaningfulness. This decision has sparked significant controversy and an appeal from Sydnexis, alongside a petition by over 1,000 doctors and statements from professional organizations urging access to the therapy. The rejection creates a regulatory divergence with the European Medicines Agency, which approved the formulation based on shorter-term data, leaving US clinicians and patients in a holding pattern.Ophthalmology TimesEuropean Commission approves low-dose atropine eye drop Ryjunea, Santen announcesThe European Commission has granted marketing authorization for Ryjunea, a low-dose atropine eye drop developed by Santen Pharmaceutical Co., Ltd. and licensed from Sydnexis Inc., to treat myopia progression in children aged 3 to 14. This approval follows a positive opinion from the European Medicines Agency based on Phase III STAR study results showing a 30% reduction in annual myopia progression compared to placebo. Santen will lead commercialization efforts in Europe, the Middle East, and Africa, while the FDA has set a PDUFA date of October 23, 2025, for potential US approval.Optometry TimesPhase 3 STAR trial data show SYD-101 met primary, secondary end points in pediatric myopiaSydnexis announced that its SYD-101 treatment met both primary and secondary efficacy endpoints in the Phase 3 STAR trial for pediatric myopia, demonstrating significant reduction in disease progression across diverse patient groups. The data, presented at the AAPOS annual meeting, indicated that the drug was well-tolerated with no unexpected adverse events and showed particular benefit for younger children and fast progressors. These results support Sydnexis's ongoing discussions with the FDA regarding potential approval in the United States.Contemporary PediatricsFDA issues CRL for SYD-101 to treat progression of pediatric myopiaThe FDA issued a complete response letter for Sydnexis' SYD-101, rejecting the New Drug Application for treating pediatric myopia due to insufficient efficacy data despite the Phase 3 STAR trial meeting its primary endpoints. The agency noted no safety or manufacturing deficiencies but stated the data did not support the overall effectiveness of low-dose atropine in children. Sydnexis expressed disappointment and intends to work with the FDA to determine the next steps for potential resubmission.Optometry TimesFDA accepts NDA for low-dose atropine from SydnexisThe FDA has accepted Sydnexis's New Drug Application for SYD-101, a low-dose atropine drop designed to manage pediatric myopia progression. The agency has set the Prescription Drug User Fee Act target action date for October 23, 2025. If approved, this treatment would become the first and only pharmaceutical option for this indication in the United States.Daily Medical NewsFDA to hold advisory meeting on SYD-101, myopia drug it declined to approveThe FDA will hold an advisory committee meeting to review SYD-101, a myopia drug developed by Sydnexis that was previously declined for approval despite meeting phase 3 trial endpoints. This meeting follows a formal dispute resolution request from Sydnexis after the FDA cited limited clinical benefit and questionable durability in its complete response letter. The company is advocating for the inclusion of pediatric eye care practitioners to discuss the real-world challenges and potential benefits of an FDA-approved alternative to compounded atropine.