EyePoint Pharmaceuticals, Inc. (EYPT): PESTLE Analysis [Nov-2025 Updated]

EyePoint Pharmaceuticals, Inc. (EYPT) is playing a high-stakes game in the ocular drug space, and the path to a win is defintely defined by macro forces. You need to look past the pipeline hype and see the real strategic tension: a potential market for Wet AMD and DME projected to exceed $15 billion in 2025 is waiting, but the US Inflation Reduction Act (IRA) looms as a political risk, and competition from biosimilars is fierce. Their core advantage, the Durasert sustained-release platform, is the technological lever that justifies their projected 2025 R&D spend of nearly $110 million, but only if they navigate the legal and economic headwinds we detail below.

EyePoint Pharmaceuticals, Inc. (EYPT) - PESTLE Analysis: Political factors

US Inflation Reduction Act (IRA) drug price negotiation risk for future products.

The US Inflation Reduction Act (IRA) of 2022 represents a significant headwind for EyePoint Pharmaceuticals, Inc.'s future revenue streams, particularly for its lead product candidate, DURAVYU (vorolanib intravitreal insert). Because vorolanib is a Tyrosine Kinase Inhibitor (TKI) and therefore a small-molecule drug, it faces a shorter exclusivity period before becoming eligible for Medicare Drug Price Negotiation (DPNP).

Under the IRA, small-molecule drugs like DURAVYU are subject to negotiation after only seven years on the market, compared to the eleven years afforded to biologics (large-molecule drugs). Given that EyePoint Pharmaceuticals is targeting the multi-billion-dollar markets of wet Age-related Macular Degeneration (wet AMD) and Diabetic Macular Edema (DME), this four-year difference in pricing freedom is material. Honestly, that seven-year clock forces a much faster commercial ramp and puts pressure on the initial launch price.

This policy has already shifted investment decisions across the industry. A 2025 study indicated that over 77% of investors reported the IRA created a disincentive away from investing in small molecules, which could make future capital raises for EyePoint Pharmaceuticals' small-molecule pipeline more challenging. Still, the company's focus on a high-value, sustained-release delivery system (Durasert E™) may partially offset this risk by demonstrating superior patient value and reduced treatment burden.

Increased FDA scrutiny on novel ocular drug delivery systems.

The regulatory environment for novel ocular drug delivery systems, such as EyePoint Pharmaceuticals' proprietary Durasert E™ technology, is characterized by heightened attention but also a clear, established pathway. The US Food and Drug Administration (FDA) is actively reviewing and approving these innovative platforms, which is a positive sign for the company's approach.

For example, in May 2025, the FDA approved a competitor's continuous delivery system, Susvimo (ranibizumab injection), for DME, which sets a precedent for long-acting ocular implants. EyePoint Pharmaceuticals also completed a positive End-of-Phase 2 (EOP2) meeting with the FDA in the second quarter of 2025 for its DURAVYU DME program, aligning on a non-inferiority pivotal Phase 3 trial design. This means the FDA has signed off on the regulatory path, which is defintely a key de-risking step.

The scrutiny focuses on the unique safety and sustained-release profile of the insert, but the company's track record with four previously approved Durasert-based products over three decades helps build regulatory confidence.

Government funding and tax incentives for rare disease (orphan drug) development.

While EyePoint Pharmaceuticals' lead candidate, DURAVYU, targets large patient populations (wet AMD and DME), the broader political support for rare disease (orphan drug) development still benefits the biotech sector and the company's historical expertise.

Key financial incentives remain in place for any future pipeline candidates targeting rare ocular diseases:

• Orphan Drug Tax Credit (ODTC): Provides a federal tax credit equal to 25% of qualified clinical testing expenses.
• IRA Exemption Expansion: The One Big Beautiful Bill Act (OBBBA), signed into law in July 2025, expanded the IRA negotiation exemption. This new law now excludes orphan drugs designated for one or more rare diseases from Medicare price negotiation, a significant protection for companies pursuing multiple rare disease indications.

Currently, there is political momentum to restore the ODTC to its original 50% rate, which would double the financial incentive for rare disease research and development (R&D). This ongoing debate shows that while the IRA pressures large-market drugs, the government is actively trying to preserve the incentives for small-market, high-need therapies.

Geopolitical stability impacting global supply chains for drug manufacturing.

The geopolitical climate in 2025 has created significant near-term supply chain risk due to new US trade policies targeting pharmaceutical imports. This directly impacts the cost of Active Pharmaceutical Ingredients (APIs) and finished drug products.

In mid-2025, the US announced plans for new tariffs on pharmaceutical imports from over 150 countries, with initial rates ranging from 20% to 40% and a warning that tariffs could rise as high as 200% over time. Specifically, tariffs of 25% on APIs from China and 20% on APIs from India were announced in June 2025.

EyePoint Pharmaceuticals is partially insulated from the immediate impact on finished product manufacturing, as its commercial-scale manufacturing facility for DURAVYU is located domestically in Northbridge, Massachusetts. This domestic base provides a clear competitive advantage by mitigating the new tariff-related cost inflation and supply disruption risks that heavily affect companies relying entirely on foreign Contract Manufacturing Organizations (CMOs).

EyePoint Pharmaceuticals, Inc. (EYPT) - PESTLE Analysis: Economic factors

High interest rates increasing the cost of capital for R&D financing.

You're a clinical-stage company like EyePoint, so the cost of capital is defintely a primary concern. The elevated interest rate environment, which has persisted into 2025, directly increases the cost of borrowing for long-cycle Research and Development (R&D) projects. This is a headwind for the entire biotech sector, making it harder to raise debt and often leading to lower valuations for growth stocks. We saw overall biotech financing decrease in 2024, creating a tough funding environment for pre-revenue firms.

EyePoint, however, has recently taken decisive action to secure its runway against this macro-economic pressure. In October 2025, the company completed an oversubscribed equity financing, raising $172.5 million in gross proceeds. This capital infusion is crucial because it fully funds the pivotal Phase 3 program for DURAVYU in Diabetic Macular Edema (DME) and extends the company's cash runway into the fourth quarter of 2027. This move insulates the company from the immediate need to seek high-cost capital, but future financing for commercialization will still face a cautious and high-rate market.

Market size for Wet AMD and Diabetic Macular Edema (DME) is projected to exceed $15 billion in 2025.

The sheer scale of the anti-VEGF market for retinal diseases is the primary opportunity for EyePoint. The global Macular Edema and Macular Degeneration market is projected to be around $11.2 billion in 2024, with a Compound Annual Growth Rate (CAGR) of 7.2% through 2034. The Wet Age-Related Macular Degeneration (Wet AMD) market alone was valued at approximately $9.53 billion in 2024.

EyePoint's focus on the two largest segments-Wet AMD and DME-targets a massive and growing patient pool driven by aging populations and rising diabetes prevalence. The CEO noted that the DME market specifically is a three-billion-dollar market and growing. The combined market for these two indications is clearly in the multi-billion-dollar range, providing a substantial revenue target for a sustained-release therapy like DURAVYU, which aims to reduce the patient's injection burden.

Competition from established, lower-cost biosimilar treatments for Lucentis and Eylea.

The anti-VEGF market is fiercely competitive, and the entry of biosimilars is putting significant downward pressure on pricing. This is a major economic risk. Established biologics like Lucentis (ranibizumab) and Eylea (aflibercept) are facing generic competition, which changes the value proposition for any new entrant.

For example, Lucentis biosimilars like Coherus BioSciences' Cimerli are priced aggressively, with one dose quoted at around $869, a substantial discount from the reference product's price of approximately $1,850 per dose. Eylea, which currently holds the dominant market share at around 43.4%, is also seeing its own biosimilar competition, with the global aflibercept biosimilars market growing to $1.68 billion in 2025.

Here's the quick math: EyePoint must compete on convenience and superior clinical outcomes (fewer injections) to justify a premium price over these cheaper, high-efficacy biosimilars. Price is not the only factor, but it's a big one.

Reimbursement policies by Medicare and private payers influencing patient access.

Reimbursement is the gatekeeper for patient access, especially in the US, where Medicare covers a large portion of the elderly population affected by Wet AMD. The Centers for Medicare & Medicaid Services (CMS) finalized a 2.8% decrease in the Medicare Physician Fee Schedule (MPFS) conversion factor for 2025. This translates to an estimated -2% overall reduction in Medicare payments to ophthalmologists, which could make physicians hesitant to adopt new, complex procedures or drugs that strain their practice economics.

Still, there are two key dynamics to watch:

• Medicare Advantage (MA) plans are seeing an average payment increase of 5.06% in 2026, which could mean more funding for eye care services, but also tighter utilization management like prior authorizations.
• The Inflation Reduction Act (IRA) introduces Medicare price negotiation for certain high-cost drugs, a policy that could substantially reduce future revenues for novel therapies, pushing companies to prioritize earlier development and commercialization.

For EyePoint, a novel sustained-release treatment will require a clear economic argument to payers-showing that reducing the frequency of in-office injections saves the healthcare system money, even if the drug itself carries a high price tag. That's the strategic lever.

EyePoint Pharmaceuticals, Inc. (EYPT) - PESTLE Analysis: Social factors

Growing aging population (65+) increases prevalence of chronic eye diseases

The demographic shift in the United States toward an older population is the single most important social factor driving demand for EyePoint Pharmaceuticals, Inc.'s pipeline. As people live longer, the prevalence of chronic, age-related eye diseases-the core focus of EyePoint's sustained-release therapies-rises dramatically. This is a clear, long-term market tailwind.

For example, the number of Americans aged 40 and older experiencing vision impairment is projected to double by 2050. More specifically, Age-Related Macular Degeneration (AMD) prevalence is increasing; a study of US Medicare beneficiaries aged 68 and older showed the diagnosed prevalence of AMD rose from 6.8% to 9.4% between 2005 and 2019. This means the patient pool for EyePoint's lead candidate, DURAVYU, which targets wet AMD and Diabetic Macular Edema (DME), is expanding significantly. The overall diagnosed prevalence of one or more chronic, age-related eye diseases in this Medicare group is already high, increasing from 15.0% to 17.9% in the same period. This isn't a future problem; it's a current, growing market reality.

High patient preference for less frequent dosing, favoring EYPT's sustained-release platforms

Patient adherence to chronic treatment regimens is defintely a major challenge, especially for conditions requiring frequent, invasive procedures like intravitreal injections. This is where EyePoint's core technology, the Durasert E sustained-release platform, offers a critical social advantage. Patients simply prefer fewer trips to the clinic and less frequent needle sticks.

The market is already shifting to accommodate this preference. Competitors have launched longer-acting formulations, like Regeneron's Eylea HD, which is approved for dosing up to every eight weeks for certain indications, directly challenging the older monthly/bi-monthly regimens. EyePoint's DURAVYU is positioned to be a first-to-market sustained-release TKI (tyrosine kinase inhibitor) in the DME market, a segment valued at $3 billion and growing. Less frequent dosing directly translates to better adherence, which means better long-term vision outcomes for patients-a powerful social selling point.

The enthusiasm for this approach is evident in the clinical trial enrollment; the Phase 3 LUGANO and LUCIA trials for DURAVYU in wet AMD were fully enrolled in a record seven months, underscoring strong physician and patient interest in a less burdensome treatment option. Less frequent dosing is a quality-of-life issue that changes the treatment calculus.

Public perception and trust in pharmaceutical companies regarding drug pricing

The social pressure on pharmaceutical drug pricing remains intense in 2025, significantly impacting public trust and regulatory risk. Americans continue to pay substantially more for patented drugs compared to other developed nations, a fact that drives bipartisan political action.

Key actions shaping this landscape include:

• The Inflation Reduction Act (IRA), which will allow Medicare to negotiate prices for a select list of high-cost drugs starting in 2026.
• Executive orders in 2025 aimed at lowering drug prices, including the pursuit of a Most-Favored-Nation (MFN) pricing policy, which seeks to benchmark US drug prices to the lowest paid by peer countries.

While EyePoint is a clinical-stage company with DURAVYU not yet on the market, the overall environment is one of scrutiny. Total US pharmaceutical expenditures are expected to rise by 9.0% to 11.0% in 2025, keeping the spotlight firmly on costs. For a new drug like DURAVYU, its eventual pricing strategy must be carefully framed to demonstrate value-specifically, the cost-benefit of a sustained-release drug that reduces the number of expensive, in-office procedures and associated clinic costs. If the drug is perceived as just another high-cost injection, it will face significant payer and public pushback.

Increased awareness and early diagnosis of retinal diseases through telehealth

The rapid expansion of telehealth (TH) and teleophthalmology is a positive social trend for EyePoint, as it facilitates earlier diagnosis and better patient monitoring, ultimately increasing the addressable market of diagnosed patients. This is especially true for chronic conditions like Diabetic Retinopathy (DR) and AMD, where early detection is crucial for preserving vision.

Telehealth-based screening programs, often utilizing remote imaging and Artificial Intelligence (AI) algorithms, are proving highly effective and cost-efficient. For instance, a virtual care program for patients overdue for Diabetic Retinopathy evaluation found an abnormality in 34.6% of the 790 patients enrolled. Furthermore, completing a telehealth visit was associated with a significantly higher likelihood of detecting new wet AMD (Odds Ratio: 3.3) in dry AMD patients, leading to earlier treatment.

The adoption of AI-based systems, such as the FDA-cleared LumineticsCore and EyeArt for autonomous DR screening, is making remote diagnosis faster and more scalable. This technological shift means more patients will be diagnosed earlier in their disease progression, creating a larger population ready for effective, long-acting treatments like DURAVYU. The efficiency is compelling: one pilot program found teleophthalmology screening to be cost-saving at USD $82.4 per patient versus USD $237.8 for in-person screening.

EyePoint Pharmaceuticals, Inc. (EYPT) - PESTLE Analysis: Technological factors

You're looking at EyePoint Pharmaceuticals' technological moat and wondering if it's deep enough to hold back the next wave of innovation. The short answer is yes, for the near-term, because their sustained-release platforms offer a clear, immediate advantage in patient compliance and treatment burden. But honestly, the long-term view requires a hard look at the curative potential of gene editing.

Durasert and Verisome sustained-release technology provides a key competitive advantage.

EyePoint's proprietary drug delivery technology, Durasert, is their core competitive edge. This platform, and its newer bioerodible iteration, Durasert E, is engineered for sustained intraocular delivery, meaning a single injection can release a drug consistently over months or even years. The non-erodible Durasert is already used in four FDA-approved products, including YUTIQ for chronic non-infectious uveitis, which provides drug release over three years.

The Durasert E technology, used in their lead candidate DURAVYU (vorolanib intravitreal insert), is particularly compelling because it eliminates the need for frequent injections, which is a major pain point for patients with chronic retinal diseases. This new insert is composed of 94% drug and only 6% matrix, and it is designed to release the drug for at least six months. This is a massive improvement over current anti-VEGF biologics that often require monthly or bi-monthly dosing.

• Durasert E: Bioerodible, 94% drug load, no cold storage required.
• Durasert: Non-erodible, used in four FDA-approved products, up to a three-year release profile.
• Verisome: Another proprietary platform for liquid-based, sustained-release formulations.

EYP-1901 (vorolanib) Phase 2 results showing potential for 6-month dosing intervals.

The clinical data for DURAVYU (formerly EYP-1901) strongly validates the Durasert E technology's potential for a six-month dosing interval. The Phase 2 VERONA trial in diabetic macular edema (DME) reported positive 6-month results in February 2025, which showed the drug met its primary endpoint of extended time to first supplemental injection compared to the standard-of-care aflibercept.

The data demonstrated clinically meaningful outcomes, including an average improvement in best-corrected visual acuity (BCVA) of +7.1 letters from baseline in one of the DURAVYU arms. Anatomically, central subfield thickness (CST) improved by 7.59 µm. These results are why the Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), LUGANO and LUCIA, are designed to evaluate the non-inferiority of DURAVYU administered every 6 months against aflibercept dosed every eight weeks.

Advancements in gene therapy and CRISPR posing long-term disruption risk.

While EyePoint is focused on durable drug delivery, the long-term technological risk comes from curative therapies like gene therapy and CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats). These technologies aim to correct the underlying genetic defects causing blindness, not just manage the symptoms.

For example, a human trial using a next-generation CRISPR 3.0 platform successfully restored vision in patients with a form of genetic blindness (Leber congenital amaurosis) in a breakthrough announced in April 2025. This represents a paradigm shift: a one-time, potentially curative treatment versus a chronic, sustained-release treatment. If gene-editing can be successfully applied to more common, non-inherited retinal diseases like wet AMD, it would defintely disrupt the entire anti-VEGF market, including EyePoint's sustained-release model.

High R&D expenditure, focused on pipeline progression.

The company is making a massive financial commitment to push DURAVYU through the final stages of clinical development. For the first nine months of the 2025 fiscal year, EyePoint Pharmaceuticals reported total Research and Development (R&D) expenses of approximately \$161.8 million. This is a significant increase, underscoring the high cost of running large, global Phase 3 trials.

Here's the quick math: The R&D expense for the third quarter alone (ending September 30, 2025) was \$47.8 million, representing a 62% surge compared to the same period in 2024. This spending is laser-focused on the pivotal trials for DURAVYU, including the fully enrolled wet AMD trials (LUGANO and LUCIA) and the initiation of the pivotal Phase 3 DME program (COMO and CAPRI) expected to begin dosing in Q1 2026. This heavy investment is necessary to secure a first-to-market position among sustained-release therapies.

Finance: Track R&D spend against clinical milestones quarterly to ensure capital efficiency.

EyePoint Pharmaceuticals, Inc. (EYPT) - PESTLE Analysis: Legal factors

You need to understand that in the biopharma world, legal factors aren't just about avoiding lawsuits; they are the foundation of your entire business model. For EyePoint Pharmaceuticals, Inc., this means the strength of their intellectual property (IP) is directly tied to future revenue, and regulatory compliance dictates their timeline to market. Honestly, if you lose your patent exclusivity, you lose the game.

Patent protection strength for Durasert and Verisome platforms is critical for exclusivity

The core value of EyePoint Pharmaceuticals, Inc. lies in its proprietary drug delivery platforms, Durasert and Verisome. The Durasert platform, specifically the next-generation bioerodible Durasert E™ technology used in their lead candidate DURAVYU™, is the key to sustained intraocular delivery, which is a major competitive advantage. This technology protects the drug from immediate generic competition.

The company maintains a robust patent portfolio to protect its approved products and pipeline. For example, patents covering the delivery mechanism for their approved product DEXYCU® extend exclusivity out to 2034 and 2032 in the U.S., which is a significant period of market protection. Losing patent protection early, or having a competitor successfully challenge it, would instantly erode the company's ability to generate monopoly profits.

Here's a quick math: A patent that expires in 2034 provides 9 more years of exclusivity than one expiring in 2025. That's a huge difference in projected cash flow.

Strict FDA requirements for Biologics License Applications (BLA) for new therapies

The path to commercializing a new drug in the U.S. is long, expensive, and governed by the Food and Drug Administration (FDA). While DURAVYU™ (vorolanib intravitreal insert) is an investigational product, its eventual approval will require a successful New Drug Application (NDA) or Biologics License Application (BLA) submission, which demands exhaustive clinical data on safety and efficacy.

As of November 2025, DURAVYU™ is in two global Phase 3 pivotal trials for wet Age-Related Macular Degeneration (wet AMD), LUGANO and LUCIA, with enrollment complete at over 900 patients. The complexity of these trials is immense, and the FDA's scrutiny is unforgiving. Any delay in the expected topline data readout, currently anticipated in mid-2026, pushes back the potential BLA submission and, critically, the market entry date.

The company is already preparing its Northbridge, Massachusetts commercial manufacturing facility for a pre-approval inspection (PAI), a crucial and often challenging part of the FDA's regulatory review process.

Compliance with global data privacy laws (e.g., GDPR) for clinical trials

Operating global clinical trials, such as the LUGANO and LUCIA studies, exposes EyePoint Pharmaceuticals, Inc. to a complex web of international data privacy laws. This includes the European Union's General Data Protection Regulation (GDPR) and the evolving state-level regulations in the U.S. like the California Consumer Privacy Act (CCPA) and its amendments.

These regulations impose strict rules on how patient data-which is highly sensitive health information-is collected, processed, stored, and transferred across borders. Non-compliance is not a minor issue; it creates a material financial risk.

• Risk: Government enforcement actions, including civil or criminal penalties.
• Cost: Compliance costs redirect R&D resources away from drug development.
• Action: Must maintain a robust compliance framework for all 900+ clinical trial patients.

Failure to comply with these privacy laws could result in significant fines and, worse, jeopardize the integrity and acceptance of the clinical trial data by regulatory bodies like the FDA and the European Medicines Agency (EMA).

Intellectual property disputes with competitors over drug formulation and delivery

The pharmaceutical industry, especially in high-value areas like sustained-release ocular therapeutics, is notorious for intellectual property (IP) litigation. EyePoint Pharmaceuticals, Inc. operates in an environment where competitors, or other third parties, frequently assert infringement claims over drug formulation and delivery systems.

The risk is real and constant. If a competitor successfully asserts that one of EyePoint's products infringes their patent, the company could be forced to pay substantial damages, stop selling the product, or obtain an expensive non-exclusive license. The latter means competitors gain access to the same technology, gutting the competitive edge.

The company must invest significant time and expense to defend its IP, which is a drain on its strong cash position of approximately $256 million as of June 30, 2025. This cash reserve is intended to fund operations into 2027, but a major IP loss could quickly change that runway. Defending a single patent case can easily cost tens of millions of dollars.

EyePoint Pharmaceuticals, Inc. (EYPT) - PESTLE Analysis: Environmental factors

Managing the disposal of specialized medical waste from ophthalmic procedures.

The environmental risk here isn't just about the manufacturing plant; it's about the product's use in the field. EyePoint Pharmaceuticals' core pipeline asset, DURAVYU, uses the Durasert E™ technology, which is a sustained-release, bioerodible implant delivered via a standard in-office intravitreal (IVT) injection. The good news is the implant itself is bioerodible, meaning it breaks down naturally, avoiding the long-term bio-persistence issue of older, non-erodible implants.

But still, the delivery system creates a regulated waste stream. This is a critical downstream environmental factor that EyePoint Pharmaceuticals must manage through its product design and user guidelines. The waste generated at the retina clinic level falls into two main categories:

• Sharps Waste: The single-use injection apparatus used to deliver the Durasert E™ implant.
• Pharmaceutical Waste: Any unused or expired drug product, though the Durasert E™ system is designed for a single, complete dose.

The US medical waste management market is a massive compliance landscape, projected to reach $27.63 billion by 2035, so this isn't a minor cost center for clinics, and EyePoint Pharmaceuticals needs to offer clear, compliant disposal protocols to its customers. The company's focus should be on designing the smallest possible delivery system to minimize the volume of sharps waste generated per procedure. That's a clear action item for their engineering team.

Corporate focus on reducing energy consumption in manufacturing and logistics.

EyePoint Pharmaceuticals has made a concrete commitment to environmental responsibility with its new 41,000 square foot commercial manufacturing facility in Northbridge, Massachusetts, which became fully operational in 2025. This facility is the production hub for DURAVYU, so its environmental footprint is a direct reflection of the company's operational impact.

The company has explicitly stated that the Northbridge facility integrates twenty-eight ESG-centric elements into its design. This is where you see the real-world commitment, not just platitudes. Here's the quick breakdown from their reporting:

The fact they have a robust, propane-fired electric generator capable of powering the entire facility for up to four days also shows a dual focus on both energy resilience and operational continuity, which is smart risk management. The next step is to publish the actual 2025 energy consumption (in kWh) and GHG emissions (in metric tons of CO2e) for this facility, establishing a clear baseline for future reduction targets.

Increasing stakeholder pressure for transparent Environmental, Social, and Governance (ESG) reporting.

The pressure for transparent ESG reporting is no longer a niche investor trend; it's a mainstream expectation, especially for publicly traded biotechs. EyePoint Pharmaceuticals is defintely aware of this, having released its 2024 ESG Performance Report as of late 2025. This shows a proactive stance on transparency and accountability to stakeholders-from institutional investors like BlackRock, who increasingly screen for ESG compliance, to potential partners and employees.

The company's Board of Directors, through its Governance and Nominating Committee, provides direct oversight for ESG policies, which signals that environmental strategy is being discussed at the highest level. You can't ask for more direct accountability than that.

The key risk here is moving from qualitative commitments to quantitative, auditable metrics. Investors now want to see the 'E' in ESG tied to real numbers, like a reduction in Scope 1 and 2 emissions year-over-year from the Northbridge facility's 2025 baseline. Failure to provide granular data in the next 2025 report will be seen as a step backward in transparency.

Regulatory mandates on packaging and supply chain sustainability.

The regulatory landscape for packaging sustainability is shifting rapidly in the US, and this directly impacts EyePoint Pharmaceuticals' supply chain for DURAVYU and other products. The biggest near-term risk is the rise of Extended Producer Responsibility (EPR) laws.

EPR laws, now enacted in states like California, Maine, Oregon, and Colorado, shift the financial and operational burden of managing packaging waste from municipalities to the product manufacturer. For EyePoint Pharmaceuticals, this means the cost of their product packaging's end-of-life management is now a direct operating expense, not an externalized cost.

Specific 2025 mandates include:

• PCR Content Mandates: New Jersey requires plastic packaging for household and personal care products to contain a minimum of 15% Post-Consumer Recycled (PCR) content in 2025. While ophthalmic packaging is specialized, this trend is coming for all sectors.
• Reporting Deadlines: In states like California, producers must register with a Producer Responsibility Organization (PRO) by April 1, 2025, and begin reporting packaging data by August 1, 2025.

EyePoint Pharmaceuticals must ensure its Supplier Code of Conduct, which covers environmental matters, is actively enforced with its packaging vendors. The smart move is to proactively redesign commercial packaging for DURAVYU now to maximize recyclability and incorporate high levels of PCR content, staying ahead of the regulatory curve before the 2026 commercial launch timeline.