Opsis Therapeutics
Opsis Therapeutics is a private Madison, Wisconsin-based biotech founded in 2016 as a joint venture between FUJIFILM Cellular Dynamics and David Gamm, M.D., Ph.D., developing iPSC-derived cell replacement therapies for dry AMD and primary photoreceptor diseases, with lead candidate OpCT-001 licensed to BlueRock Therapeutics and currently in Phase 1/2a clinical trials.
- Company typePrivate
- Founded2016
- HeadquartersMadison, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Opsis Therapeutics does
Opsis Therapeutics is a private clinical-stage biotechnology company founded in 2016 as a joint venture between FUJIFILM Cellular Dynamics and Dr. David Gamm, M.D., Ph.D., headquartered in Madison, Wisconsin. The company develops iPSC-derived cell replacement therapies for ocular diseases, with a pipeline targeting dry age-related macular degeneration (AMD) and primary photoreceptor diseases such as retinitis pigmentosa. Its core technology platform integrates induced pluripotent stem cell (iPSC) generation, three-dimensional optic vesicle-based retinal cell differentiation (first described in the Gamm laboratory), and functional biomaterials to produce photoreceptors and other retinal cells for transplantation. The lead candidate, OpCT-001, is an iPSC-derived cell therapy for primary photoreceptor diseases that received FDA IND clearance in September 2024, FDA Fast Track Designation in February 2025, and began dosing in the CLARICO Phase 1/2a clinical trial in July 2025.
Opsis operates a partnership- and licensing-driven business model rather than a direct commercialization model. In May 2021, the company entered a strategic R&D alliance with BlueRock Therapeutics (a Bayer subsidiary) and FUJIFILM Cellular Dynamics, which included a $70 million up-front payment from Bayer. In January 2024, BlueRock exercised its exclusive option to license OpCT-001, advancing it through clinical development and bearing downstream commercialization responsibility. Opsis therefore generates revenue through upfront payments, development and regulatory milestones, and royalties on licensed candidates, while day-to-day clinical execution is conducted by its larger partner. The company is small (1-10 employees) and is structured as Opsis Therapeutics, LLC under Wisconsin jurisdiction, with a co-founder-led operating team and a Scientific Advisory Board.
The company's strategic posture is best characterized as a focused, asset-light development organization that monetizes its platform and lead candidate via licensing to large pharma, while leveraging the iPSC capabilities of its parent (FUJIFILM Cellular Dynamics) and the academic retinal regeneration expertise of its scientific founders. With OpCT-001 now in Phase 1/2a and additional dry AMD programs in earlier-stage development, Opsis is positioned as a clinical validation-stage player in the ocular cell therapy space, with FDA Orphan Drug Designation providing potential seven years of market exclusivity upon approval.
Opsis Therapeutics firmographics
Firmographics- Name
- Opsis Therapeutics
- Legal name
- Opsis Therapeutics, LLC
- Website
- https://opsistx.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Opsis Therapeutics is a private Madison, Wisconsin-based biotech founded in 2016 as a joint venture between FUJIFILM Cellular Dynamics and David Gamm, M.D., Ph.D., developing iPSC-derived cell replacement therapies for dry AMD and primary photoreceptor diseases, with lead candidate OpCT-001 licensed to BlueRock Therapeutics and currently in Phase 1/2a clinical trials.
- Ownership category
- akta.pro rank
Opsis Therapeutics industry classification
Industry- Product category
- Cell Therapy for Retinal Diseases
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE)
- akta.pro secondary industries
- Ophthalmic Regeneration (cornea/retina) (HLAAAGAK), Rare Ophthalmology Disorder Therapies (HLAIAIAK), Stem Cell–Based Regenerative Therapies (HLAAAGAA)
Keywords
Where Opsis Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Madison
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Opsis Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain
Revenue model
- Licensing and Strategic Partnerships: Opsis generates value through licensing its iPSC-derived cell therapy candidates to larger pharmaceutical companies. The company entered a strategic R&D alliance with BlueRock Therapeutics and FUJIFILM Cellular Dynamics, with BlueRock exercising an exclusive option to license OpCT-001. Revenue is generated through upfront payments, milestone payments, and royalties from licensed candidates.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels1 record
Opsis Therapeutics product offering
Product offeringCore offering
Opsis Therapeutics develops iPSC-derived cell replacement therapies for ocular diseases, with a lead candidate (OpCT-001) targeting primary photoreceptor diseases and additional programs for dry age-related macular degeneration (AMD). The company's platform combines induced pluripotent stem cell (iPSC) generation, retinal cell differentiation, and functional biomaterials to create disease-modifying cell therapies administered through clinical trial sites and licensed to larger pharmaceutical partners.
Product overview
Opsis Therapeutics is developing a pipeline of cell replacement therapies targeting ocular diseases, specifically dry age-related macular degeneration (AMD) and primary photoreceptor diseases. The company's core technology platform leverages induced pluripotent stem cell (iPSC) generation, retinal cell differentiation, and functional biomaterials. Their lead candidate, OpCT-001, is an iPSC-derived cell therapy for primary photoreceptor diseases that has been licensed to BlueRock Therapeutics and is currently in Phase 1/2a clinical trials. The company was founded in 2016 as a joint venture of FUJIFILM Cellular Dynamics and David Gamm, M.D., Ph.D.
Differentiator
Problem solved
Functional benefit
Quantifiable outcome
- OpCT-001 received FDA Orphan Drug Designation, providing potential seven years of market exclusivity upon approval plus tax credits and user fee exemptions
- +1 more outcomes
Companies that use Opsis Therapeutics
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles1 record
Opsis Therapeutics technology and API
TechnologyAPI detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Opsis Therapeutics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- BlueRock TherapeuticscoreBlueRock Therapeutics entered into a strategic R&D alliance with FUJIFILM Cellular Dynamics and Opsis Therapeutics to discover and develop cell therapies for eye diseases. BlueRock exercised its exclusive option in January 2024 to license OpCT-001, an iPSC-derived cell therapy for primary photoreceptor diseases. OpCT-001 is being advanced through the CLARICO Phase 1/2a clinical trial.
- FUJIFILM Cellular DynamicscoreFUJIFILM Cellular Dynamics is a co-founder of Opsis Therapeutics through a joint venture arrangement. The partnership combines FUJIFILM Cellular Dynamics' expertise in iPSC technology with Opsis Therapeutics' ocular disease focus. The joint venture leverages FUJIFILM's iPSC platform capabilities for developing cell replacement therapies.
Scale indicators3 records
Recent moves6 records
Expansion highlights4 records
Opsis Therapeutics competitors and assessment
Company assessmentDirect peers
- BlueRock Therapeutics: Bayer subsidiary that licensed OpCT-001 from Opsis Therapeutics in January 2024 and is now running the CLARICO Phase 1/2a trial. Most directly comparable as a clinical-stage cell therapy developer focused on ocular disease using iPSC-derived approaches.
- Lineage Cell Therapeutics: Clinical-stage cell therapy company developing allogeneic retinal pigment epithelium (RPE) cell transplants for dry AMD and other retinal diseases. Directly comparable as a retinal cell replacement therapy peer.
- jCyte: Clinical-stage biotech developing allogeneic human retinal progenitor cells (jCell) for retinitis pigmentosa — a direct indication overlap with OpCT-001 and a directly comparable cell therapy approach in inherited retinal disease.
- ReNeuron: UK-based stem cell therapy developer with a retinal program (hRPC cells for retinitis pigmentosa). Compares directly to Opsis in stem cell-derived photoreceptor replacement therapies for inherited retinal disease.
Others
- FUJIFILM Cellular Dynamics: Joint venture parent of Opsis Therapeutics and a leading iPSC technology platform. Operates in the same iPSC-derived cell therapy space and provides the underlying cell line and differentiation capabilities that Opsis leverages.
Broad incumbents
- Spark Therapeutics: Roche subsidiary and pioneer in gene therapy for inherited retinal diseases (e.g., LUXTURNA for RPE65-mediated IRD). Represents the dominant gene therapy incumbent competing for the same patient population as OpCT-001.
- Astellas Institute for Regenerative Medicine: Astellas' cell therapy division (formerly Universal Cells) develops stem cell-derived therapies for ophthalmology. Represents a broader incumbent with overlapping regenerative medicine capabilities in ocular indications.
Emerging players
- Editas Medicine: CRISPR gene editing company developing EDIT-101 (reniFiguren-cel) for Leber congenital amaurosis 10 — overlapping inherited retinal disease focus with Opsis, though differentiated as a gene editing rather than cell replacement approach.
- ProQR Therapeutics: RNA editing company developing sepofarsen for Leber congenital amaurosis and additional RNA therapies targeting inherited retinal diseases. Competes for the same patient population with a different modality.
- Coave Therapeutics: European gene therapy company developing AAV-based therapies for ocular diseases including retinitis pigmentosa. Targets overlapping patient population to Opsis via a gene therapy modality.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Opsis Therapeutics social profiles
Digital presenceOpsis Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Opsis Therapeutics leadership team
Management profileNumber of profiles
Opsis Therapeutics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Opsis Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Opsis Therapeutics
What does Opsis Therapeutics do?
Opsis Therapeutics develops iPSC-derived cell replacement therapies for ocular diseases, with a lead candidate (OpCT-001) targeting primary photoreceptor diseases and additional programs for dry age-related macular degeneration (AMD). The company's platform combines induced pluripotent stem cell (iPSC) generation, retinal cell differentiation, and functional biomaterials to create disease-modifying cell therapies administered through clinical trial sites and licensed to larger pharmaceutical partners.
Is Opsis Therapeutics a public or private company?
Opsis Therapeutics is a private company. It is classified as corporate owned and is currently operating.
When was Opsis Therapeutics founded?
Opsis Therapeutics was founded in 2016. It employs 1 to 10 people.
Where is Opsis Therapeutics based?
Opsis Therapeutics is headquartered in Madison, United States, in the North America region.
How does Opsis Therapeutics make money?
One revenue line is on record: licensing and Strategic Partnerships.
Who are Opsis Therapeutics's main competitors?
Direct peers on record are BlueRock Therapeutics, Lineage Cell Therapeutics, jCyte and ReNeuron. FUJIFILM Cellular Dynamics is listed as an others. Broad incumbents are Spark Therapeutics and Astellas Institute for Regenerative Medicine. Emerging players are Editas Medicine, ProQR Therapeutics and Coave Therapeutics.
Does Opsis Therapeutics have an API?
No public API is recorded for Opsis Therapeutics.
What industry is Opsis Therapeutics in?
Opsis Therapeutics's product category is Cell Therapy for Retinal Diseases. Its primary akta.pro industry code is HLAAABAE, Stem Cell Therapies (MSC/iPSC/HSC-derived), with a secondary code of HLAAAGAK, Ophthalmic Regeneration (cornea/retina). Its NAICS code is 541714 and its SIC code is 2836.