The 36-Month Launch Sequence for an Eye-Care Product Company

Most plans for this category fail on sequencing, not on ambition. An ophthalmology drugs and devices company is really three different businesses sharing a name: an over-the-counter or prescription drug company, a medical device company, or a combination of the two. Each has a different clock, a different regulator, and a different cash curve. Before any financial table makes sense, the plan has to say which lane the first product sits in, because everything else, from hiring to the size of the raise, follows from that choice.

The sequence below assumes a first product in the device lane with a 510(k) route, because that is the most common first product for a founder-led team with under $2 million. Drug-lane founders should read the same table but stretch every phase and add a zero to the budget. The licensing and cost sections that follow spell out the differences.

Where the schedule slips

Three phases cause nearly all the overruns. The first is biocompatibility: any surface that touches the eye or the tear film needs testing, and a failed cytotoxicity or irritation result sends you back to materials selection, which costs a quarter. The second is the pre-submission step. Founders skip it to save six weeks and then lose six months when FDA asks for clinical data they assumed was unnecessary. The third is the gap between clearance and revenue. A cleared device is not a sold device, and an ambulatory surgery center purchasing committee typically takes two to three quarters to decide on a capital item.

Build the plan with explicit cash buffers for these three slips. A sensible convention is to add 20 percent to every phase duration and 15 percent to every phase budget, then show the investor the unbuffered figures next to the buffered ones. Reviewers trust a plan that shows its own contingency more than one that claims everything runs to schedule.

If your product is a drug rather than a device, the timeline stretches. An over-the-counter eye drop made to the FDA monograph can reach market in 9 to 14 months because no new drug application is needed. A prescription product through the 505(b)(2) route typically runs 4 to 7 years from formulation to approval, and a new molecular entity longer than that. The plan should state this plainly in the executive summary, because a lender reading a 36-month device timeline and a 6-year drug timeline in the same document will assume the authors do not understand the difference.

What You Must Fund Before the First Sale

The most useful single table in a plan for this sector is the one that shows three lanes side by side, because investors compare the lane you chose against the two you did not. The figures below are Avvale planning estimates assembled from published fee schedules and typical contractor quotes. They are ranges, not quotes, and each one is explained underneath.

The fee line items that are published and fixed

Some costs are not estimates. For fiscal year 2026 the FDA 510(k) user fee is $26,067 at the standard rate and $6,517 for a qualifying small business, a 75 percent discount, according to FDA's MDUFA fee schedule, FY2026. A PMA is a different order of magnitude at $579,272 standard or $144,818 for small businesses, as summarised in MedDeviceGuide's PMA cost breakdown, 2026. Small business status requires gross receipts of $100 million or less, including affiliates, and the status certification has to be approved before the submission is filed, so put it on the timeline in month 15, not month 22.

On the drug side, the FY2026 prescription drug application fee is $4,682,003 for an application with clinical data and $2,341,002 for one without, with a program fee of $442,213, per the Federal Register notice of FY2026 prescription drug user fee rates. Those numbers terrify first-time founders, and rightly, but FDA offers a small business waiver of the application fee for a company's first human drug application. Ocuphire Pharma received exactly that waiver for an ophthalmic NDA, and a plan that models the waiver as an assumption, with the application date as the trigger, is more credible than one that ignores the fee or one that budgets $4.7 million it may never pay.

The clinical line, which is where drug plans are won or lost

Ophthalmology trials are expensive. Published reviews of clinical development cost, including work summarised by HHS's ASPE review of clinical trial costs, put ophthalmology among the costlier therapeutic areas, with figures of roughly $30.7 million for a phase 3 programme and an average near $49.9 million across phases 1 to 3. A reformulation using an already approved active ingredient can avoid much of that spend through the 505(b)(2) pathway, relying on existing safety literature and running smaller bridging studies. A novel molecule cannot. The plan must be explicit about which of those two situations applies, because the raise size differs by an order of magnitude.

Funding routes by lane

• Distribution or OTC lane, US: an SBA 7(a) loan. Most 7(a) loans cap at $5 million and Express loans at $500,000, per the SBA 7(a) terms and conditions. Lenders will want inventory, receivables and a named distributor, not a regulatory story.
• Distribution or OTC lane, UK: the British Business Bank Start Up Loan, up to £25,000 per person at a fixed 7.5 percent over one to five years, with more than one owner each able to apply, as set out in ExpertSure's 2026 Start Up Loan guide. It is a top-up, not a primary source, at these budget levels.
• Device lane: equity. Angels and seed funds underwrite the clearance milestone, so the plan should show tranche releases tied to design freeze, pre-submission feedback and clearance. In the UK, SEIS and EIS eligibility is worth a paragraph of its own, because it changes the effective risk for a private investor.
• Drug lane: venture capital, strategic partners (large ophthalmology companies license assets after phase 2), and non-dilutive grants. A bank will not lend against a pre-approval drug.

For founders who need the document itself, our Research and Content package ($300 / £250) covers the research layer, and the Bespoke Business Plan ($1,000 / £800) adds the five-year model with the lane-specific funding assumptions above.

Who You Will Actually Hire: Named Partners by Function

A plan that says "we will outsource manufacturing" has not been thought through. Investors in this sector fund a team plus a partner network, and they know the partner names. The list below groups real organisations by the function they serve. Inclusion is not an endorsement and prices vary by project, so use it as a starting shortlist for quotes.

How to use the list in your plan

For each function, shortlist two partners and put one real quote in the model. Investors read the quote ranges as a test of whether the budget came from a spreadsheet or a phone call. For a device company, the testing laboratory and the notified body quotes are the two most scrutinised, because they sit on the critical path. For a drug company, the CRO and the dispensing component supplier matter most, since ophthalmic formulation lives or dies on container compatibility and preservative choice.

The last row of the table matters more than it looks. Alcon, with reported 2025 sales above $10 billion, and Bausch + Lomb, with 2025 revenue of $5.101 billion, are the logical channel partners or acquirers for most of what a small company builds, and the Bausch + Lomb full-year 2025 results release gives a precise picture of where they are growing: its surgical segment reached $894 million, up 6 percent. A plan that names which strategic buyer would want the product, and why, shows the exit logic from page one.

One practical warning on contract manufacturers: sterile ophthalmic fill capacity is tight and many contract fillers set minimum batch sizes that exceed a startup's first-year demand. If your forecast says 60,000 units in year one and the minimum validated batch is 150,000, you are either carrying inventory you cannot sell before expiry or paying a premium for a pilot batch. Model both.

Regulatory Route: US, UK, EU and Beyond

Regulatory strategy is the part of this plan that cannot be borrowed from a generic healthcare template. The categories below are the decisions that fix your timeline and your cost, in the order you should make them.

Step one: is it a drug, a device or a combination?

The legal classification follows the primary mode of action, not the shape of the product. A bottle of drops that works pharmacologically is a drug in the US. A product that works physically, such as a lubricant that coats the surface or a viscoelastic, can be a device. Under EU rules, substance-based products that are introduced into the body or applied to it can be classified as devices in higher risk classes, which is why some ophthalmic drops carry a CE mark rather than a marketing authorisation. Mixed-mechanism products and drug-delivery implants are combination products and trigger a lead-centre assignment at FDA. Request a classification opinion early, in writing, before you spend on design.

United States

• OTC monograph drops: certain ophthalmic ingredients such as demulcents and astringents can be marketed under FDA's OTC monograph without a new drug application, provided the formulation, labelling and cGMP manufacturing meet the monograph. The company still registers its establishment, lists the drug and complies with current good manufacturing practice, but avoids the NDA fee and the clinical programme. This is the fastest legitimate route into the category and the most under-discussed.
• 510(k) clearance: for Class II devices with a legally marketed predicate. FDA fee $26,067 standard or $6,517 for small business in FY2026, with a 90 FDA-day review clock plus the time you spend answering questions. A Q-Submission in advance is voluntary and worth doing.
• De Novo: for novel low-to-moderate risk devices with no predicate. It costs more and takes longer, but the cleared device becomes the predicate others must reference, a real competitive moat.
• PMA: for Class III devices such as implants with high risk profiles. User fee $579,272 standard or $144,818 small business, plus clinical data that often runs into the tens of millions.
• NDA (505(b)(1) or 505(b)(2)): for prescription drugs. Fee of $4,682,003 with clinical data, $2,341,002 without, for FY2026, with the first-application small business waiver available to qualifying companies.
• Always: FDA establishment registration, product listing, a quality system aligned with 21 CFR Part 820 (now harmonised toward ISO 13485 under the Quality Management System Regulation), medical device reporting procedures and unique device identification labelling.

United Kingdom

• MHRA registration: every device placed on the Great Britain market must be registered with the MHRA. Manufacturers outside the UK need a UK Responsible Person, a Great Britain-based legal entity accountable for registration, vigilance and post-market surveillance.
• CE and UKCA recognition: the rules for recognising CE-marked devices in Great Britain have been in transition, and sources including PureClinical's 2026 summary and a Latham and Watkins note on the MHRA consultation describe a proposal to allow EU MDR CE-marked devices on the GB market without a fixed end date, subject to registration and post-market obligations. The position has moved more than once, so check the MHRA's current guidance in the week you finalise the plan and state the date of your check in the document.
• Medicines: a prescription or pharmacy-only eye drop needs an MHRA marketing authorisation, a manufacturer's licence for the UK site, and a Qualified Person releasing batches. General sale list products follow lighter labelling rules.
• Clinical investigations: approval by MHRA and a research ethics committee, usually through the combined review route.

European Union

Under the EU Medical Device Regulation, most ophthalmic devices land in Class IIa or IIb, and the notified body route is not optional. Published cost summaries put total CE marking cost at roughly €32,000 to €110,000 for Class IIa and €70,000 to €220,000 for Class IIb, with timelines of about 12 to 20 months and 14 to 24 months respectively, per MedDeviceGuide's 2026 CE marking breakdown. Notified body capacity remains the binding constraint, so contact two bodies before you finalise the Gantt chart. Medicines go through the European Medicines Agency centralised procedure or national routes.

Other markets worth one paragraph

Founders asking where to go second should rank markets by how much of the first dossier transfers. Canada accepts a device licence application supported by an MDSAP certificate, so one audit can serve the US, Canada, Australia, Brazil and Japan. Japan requires a marketing authorisation holder and local approval through PMDA, with a fee and a timeline measured in quarters. A plan that lists five countries without saying which dossier covers which is a plan that has not costed the work.

Reimbursement is a regulatory-sized problem

Clearance lets you sell. Reimbursement lets customers buy. Cataract-adjacent devices depend on CPT codes and facility fees for ambulatory surgery centers; glaucoma devices ride on procedural coding that often bundles with cataract surgery. A plan should state the code or coverage pathway the product uses, or say plainly that the product is cash-pay or capital-purchase. Investors discount a plan that discovers reimbursement after launch.

Five mistakes that sink first plans in this category

• Picking the device class by hope: assuming Class II because the predicate looks similar, then learning at pre-submission that FDA wants clinical data. Budget a scenario for each outcome.
• Treating the UK as an afterthought: launching in Great Britain without a UK Responsible Person or MHRA registration, which blocks sales regardless of CE status.
• Forgetting the minimum batch: forecasting 60,000 units against a contract filler minimum of 150,000.
• Modelling price, not utilisation: a capital device lives on procedures per installed unit, and most plans never test that variable.
• Relying on one anchor customer: a single surgery-center group or distributor above 40 percent of revenue is a diligence red flag for lenders and investors alike.

Revenue Model and Unit Economics, Worked Through

Three revenue structures cover most small companies in this category: consumables sold repeatedly, capital equipment with attached disposables, and licensing or milestone income. The two worked examples below use composite assumptions labelled as such, because the point is the shape of the arithmetic, not the specific numbers.

Example one: preservative-free lubricant eye drops, OTC monograph route

Assume a 30-vial box of 0.4 mL unit-dose vials made by a contract filler. Landed cost per vial is $0.14, so the 30 vials cost $4.20. Carton, insert and shipper add $0.60, giving a box cost of $4.80. The company sells to pharmacy wholesalers and online retailers at $9.50 per box, a gross margin of about 49.5 percent, with a shelf price of $17.99.

The sensitivity that matters here is the minimum batch. If the filler requires 150,000 vials per run, 60,000 boxes of 30 vials need 1.8 million vials a year, which fits comfortably, but a pilot batch for a first launch is the real risk. The second sensitivity is shelf life: eye drops with an 18 or 24 month expiry carry inventory risk when a retailer delists you. Model a 5 percent write-off line in year one.

Example two: a powered ophthalmic device sold to surgery centers

Assume a diagnostic or surgical-assist unit with a $18,500 capital price and a single-use disposable at $145 per procedure. The unit has a 68 percent gross margin and the disposable 78 percent. Sales cycles run six to nine months. By year three the company has 60 installed units, each averaging 22 procedures a month.

• Disposable revenue: 60 units × 22 procedures × 12 months = 15,840 procedures, times $145, equals $2,296,800.
• Capital revenue: 25 new units sold in year three at $18,500 equals $462,500.
• Total year-three revenue: $2,759,300.
• Blended gross profit: disposables at 78 percent give $1,791,504; capital at 68 percent gives $314,500; total $2,106,004, a 76 percent blended margin.

Notice what drives the model: procedure volume per installed unit. An investor will test that number harder than the unit price. If the average falls from 22 to 14 procedures a month, disposable revenue drops by about 36 percent and the year-three profit evaporates. Show the downside case in the plan, and show the training and clinical-support cost per installed site that keeps utilisation up.

Margin ranges to sanity-check your own model

Branded OTC consumables usually land between 45 and 60 percent gross margin. Capital devices with attached disposables run 65 to 80 percent. Distribution of other makers' CE-marked devices rarely exceeds 25 to 35 percent. Pre-approval drug companies show no margin at all until launch, and the plan should say so rather than invent a hockey stick. These ranges are Avvale benchmarks drawn from client models, so treat them as plausibility checks, not published statistics.

The Eye-Care Product Market in Numbers

Market-size estimates in this category disagree widely because research firms draw the boundary differently. One recent estimate values the global ophthalmic drugs and devices market at about $66.3 billion in 2025, growing at 6.8 percent a year to roughly $119.85 billion by 2034, per Growth Market Reports. Wider definitions that fold in diagnostics, vision correction and services produce figures above $90 billion for the same year. Pick one definition, cite it, and keep it constant through the plan.

Where the growth sits inside the total

Aggregate figures hide the segments a small company can realistically enter. Glaucoma surgery is a useful example. The minimally invasive glaucoma surgery segment was estimated at $1.8 billion in 2025 and projected to reach $4.2 billion by 2035, an 8.8 percent annual rate, according to Vantage Market Research. The same source puts trabecular micro-bypass stents at around 38 percent of 2025 demand and cataract-combined procedures at around 61 percent of procedure volume, which tells a founder that a glaucoma device sold into cataract workflows has a built-in installed base of operating rooms.

Glaukos is the reference case for a specialist that built a company inside one niche. Summaries of company results put its 2025 net sales near $507 million, as noted in Spherical Insights' glaucoma company roundup. It started with a single device category and expanded into corneal and drug-delivery products. That path, one cleared device, a reference-site network, then adjacent categories, is the template most credible small-company plans follow.

Competitors by tier

• Diversified majors: Alcon (over $10 billion in 2025 sales per market summaries) and Bausch + Lomb ($5.101 billion in 2025 revenue, per its own release). They buy, license and out-distribute; they rarely lose to a small company head-on.
• Category specialists: Glaukos in glaucoma and corneal care, STAAR Surgical in implantable lenses, and drug-focused specialists such as Ocuphire Pharma. These set the benchmarks for reference-site density and reimbursement support.
• Private and venture-backed entrants: ocular imaging and diagnostics companies such as Broadspot Imaging and Forus Health, which raised $7.5 million and $8 million rounds respectively according to BioSpace coverage. These are your funding comparables.

Demand drivers to cite

The tailwinds are specific. Ageing populations raise cataract, glaucoma and macular degeneration prevalence. Screen time raises dry-eye diagnosis rates. Cataract-combined procedures keep surgical volumes tied to demographics rather than economic cycles. A plan should convert these into a number: how many procedures or prescriptions in the target region, what share the product can reach given its approved indication, and how fast reference sites scale. The sentence "the market is growing" proves nothing; the sentence "our indication covers a defined share of 3.8 million annual procedures, and we reach 0.3 percent by year three" does.

For deeper context on how to position and promote products in this category, see our companion guides on marketing for ophthalmology drugs and devices businesses and how to start an ophthalmology drugs and devices business.

Questions Founders Ask First

These are the short answers to the questions that come up most often in early conversations with ophthalmic founders. Fuller treatments sit in the sections above.

How much does it cost to develop an ophthalmic drug?

It depends on the route. A reformulation of an approved ingredient through the 505(b)(2) pathway, with bridging studies, commonly needs $8 million to $20 million to reach an NDA filing. A novel molecule needs far more: ophthalmology phase 3 programmes alone have been reported at about $30.7 million. An OTC monograph product avoids the NDA entirely and can launch for roughly $120,000 to $380,000.

Do eye drops need FDA approval?

Not always. Prescription eye drops need an approved NDA or ANDA. Many over-the-counter drops, such as lubricants made from monograph ingredients, are marketed without pre-approval but must meet the monograph's formulation and labelling rules, be made under cGMP, and be registered and listed with FDA. Anything outside the monograph needs an application.

How long does a 510(k) take?

FDA's review clock is 90 FDA days, but the elapsed time is usually four to six months once you count the days the clock stops while you answer deficiency questions. Plan eight months from submission to clearance for a first-time submitter, and add the months of testing that happen before filing.

Can a startup sell ophthalmic devices in the UK after Brexit?

Yes, with registration. Devices must be registered with the MHRA, overseas manufacturers appoint a UK Responsible Person, and the device needs a valid UKCA mark or a recognised CE mark under the rules in force at the time. Recognition arrangements have changed more than once, so verify the current position with the MHRA before committing a UK launch date.

Who are the biggest ophthalmology device companies?

Alcon is the largest pure-play eye-care company with sales above $10 billion in 2025. Bausch + Lomb reported $5.101 billion for the year, with an $894 million surgical segment. Glaukos, at roughly $507 million, is the best-known specialist in glaucoma devices. Regeneron and Roche dominate the prescription retinal biologics category on the drug side.

Sample Plan Preview: Lumina Ocular Systems

The extract below shows how the executive summary and financial opening of a plan in this category should read. Lumina Ocular Systems is an invented company used to illustrate structure and realistic numbers.

What the Template Contains

The template is built for the structure investors in this sector expect, with prompts specific to regulated eye-care products. Each section tells you what to write, which numbers to bring and what a reviewer looks for.

• Executive Summary: lane statement (OTC, device, drug or combination), intended use, ask and milestone schedule on one page
• Product and Intended Use: indication, device class or drug category, predicate or reference product, differentiators
• Regulatory Strategy: pathway by market, Q-Submission plan, notified body or MHRA plan, post-market obligations
• Clinical and Evidence Plan: bench, biocompatibility, usability and clinical studies, with a budget line each
• Market and Customer Analysis: procedure or prescription volumes, segments, reimbursement route
• Competitor Analysis: majors, specialists and entrants, with a positioning map
• Operations and Supply Chain: contract manufacturers, sterilisation, batch sizes, inventory
• Go-to-Market: reference sites, key opinion leaders, distributor structure, conference calendar
• Management and Advisory Team: regulatory, clinical and quality leadership, which investors weigh heavily
• Risks and Mitigations: regulatory delay, supplier concentration, reimbursement, reimbursement timing

The optional Financial Forecast add-on, included in our $300/£250 and $1,000/£800 packages, provides a five-year Excel model with income statement, cash flow, balance sheet, break-even analysis and a milestone-linked funding schedule.

Frequently Asked Questions