Acute Ocular Pain Market Insight, Epidemiology and Market Forecast - 2030

This ‘Acute Ocular Pain (AOP)-Market Insights, Epidemiology, and Market Forecast-2030' report deliver an in-depth understanding of the AOP, historical and forecasted epidemiology as well as the AOP market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The AOP market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM AOP market size from 2018-2030. The Report also covers current AOP treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018-2030

Acute Ocular Pain (AOP) Disease Understanding and Treatment Algorithm

Acute Ocular Pain (AOP) Overview

Eye pain is a myriad of symptoms ranging from a sharp pain in the eye to mild discomfort or itching in the eyes. As the spectrum of symptom presentation varies with eye pain, the cause of these pains may vary from straightforward refractive errors to potentially sight-threatening disorders like glaucoma and uveitis. A feeling of discomfort or pain in the eye can be caused by a problem in the eye itself. It can also be caused by a problem involving any structures around the eye or referred pain from tissues with similar innervation as ocular tissues. Patients with eye pain or periorbital pain frequently present to primary care physicians, neurologists, or ophthalmologists.

Most ophthalmologic conditions producing ocular pains are associated with obvious ocular symptoms and signs like red-eye, photophobia, vision loss, or diplopia. Sometimes it poses a challenge to physicians when the pain is associated with a quiet eye or “white eye”.

Depending on where the patients experience the discomfort, eye pain can fall into one of two categories: Ocular pain occurring on the eye's surface and orbital pain within the eye.

Eye pain that occurs on the surface may be scratching, burning, or itching sensation. Surface pain is usually caused by irritation from a foreign object, infection, or trauma. Often, this type of eye pain is easily treated with eye drops or rest.

Acute Ocular Pain (AOP) Diagnosis

Vital signs are checked for the presence of fever. The nose is inspected for purulent rhinorrhea, and the face is palpated for tenderness. If the eye is red, the preauricular region is checked for adenopathy. Hygiene during the examination must be scrupulous when examining patients who have chemosis, preauricular adenopathy, punctate corneal staining, or a combination; these findings suggest epidemic keratoconjunctivitis, which is highly contagious.

The eye examination should be as complete as possible for patients with eye pain. Best-corrected visual acuity is checked. Visual fields are typically tested by confrontation in patients with eye pain, but this test can be insensitive (particularly for small defects) and unreliable because of poor patient cooperation. A light is moved from one eye to the other to check for pupillary size and direct and consensual pupillary light responses. In patients who have unilateral eye pain, a light is shined in the unaffected eye while the affected eye is shut; pain in the affected eye represents true photophobia. Extraocular movements are checked. The orbital and periorbital structures are inspected. A conjunctival injection that seems most intense and confluent around the cornea and limbus is called a ciliary flush.

A slit-lamp examination is done if possible. The cornea is stained with fluorescein and examined under magnification with cobalt blue light. If a slit lamp is unavailable, the cornea can be examined after fluorescein staining with a Wood light using magnification. Ophthalmoscopy is done, and ocular pressures are measured (tonometry). In patients with a foreign body sensation or unexplained corneal abrasions, the eyelids are everted and examined for foreign bodies.

Acute Ocular Pain (AOP) Treatment

People with ocular pain typically present or are referred to ophthalmologists or optometrists for evaluation. When there is recent trauma or surgery, or signs of an infectious or inflammatory process, treatment of the underlying process or pathologic abnormality usually results in resolution of pain. These situations represent physiologic or nociceptive pain. Such pain associated with surgery, injury, infection, or inflammation at the front of the eye is typically treated with a topical steroid, topical NSAID, systemic NSAID, lubricant ointment, gel or drops, bandage contact lens, or a few doses of oral opiate or topical anesthetic. Pain management and treatment options usually depend on the underlying condition. The most common ocular trauma is a superficial injury to the eye's anterior portion, such as a corneal abrasion or conjunctival laceration. Not only are these injuries excruciating, but they may not heal without intervention. An infection may ensue if not treated promptly. Therefore, it is important to refer the patient to a physician or eye care specialist quickly. Once the patient receives eye care, there are various prescription medications available to manage ocular pain and discomfort.

Acute Ocular Pain (AOP) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Number of Cases of Several Eye Disorders and Number of Cases of Acute Ocular Pain in Major Eye Disorders scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.

Key Findings

• In the year 2020, the total cases of Acute Ocular Pain (AOP) were estimated to be 15,029,051 cases in the 7MM, which might increase in 2030 at a CAGR of 0.65%.
• According to the publisher estimates, in 2020, it was estimated that there were 461,948, 14,243, 98,281, 710,949, 1,268,905 and 4,050,494 cases of Cataract Surgeries, Uveitis, Glaucoma Surgeries, Corneal Aberration Surgeries, Dry eye disease, and Conjunctivitis respectively that experienced acute ocular pain, in the United States.
• Among EU5 countries, Spain has the lowest number of cases of Acute Ocular Pain (AOP), which were estimated to be 1,106,840 cases in 2020.
• In Japan, 874,788 cases of AOP were estimated, which might rise in 2030.

“There are several disorders where the patients complain of the AOP. The majority of the disorders includes Cataract Surgeries, Uveitis, Glaucoma Surgeries, Corneal Aberrations Surgery, Dry Eye Disease, and conjunctivitis, in which AOP is usually experienced. In the case of Dry eye disease, the patient with severe disease mostly experiences acute ocular pain, and the prevalence is around 20-25%. Patients suffering from corneal aberration generally go for LASIK surgery, where almost all patients experience AOP.”

Acute Ocular Pain (AOP) Epidemiology

The epidemiology segment also provides the AOP epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Acute Ocular Pain (AOP) Drug Chapters

Acute Ocular Pain (AOP) Marketed Drugs

Dextenza (dexamethasone ophthalmic insert): Ocular Therapeutix

Dextenza is contraindicated in patients with active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, fungal diseases of the eye, and dacryocystitis. Dextenza is inserted in the lower lacrimal punctum and into the canaliculus. A single Dextenza releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. Dextenza is resorbable and does not require removal.

Although the drug is already approved in adults, currently it is in phase III clinical trial for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Inveltys (loteprednol etabonate ophthalmic suspension/KPI-121): Kala Pharmaceuticals

Inveltys (loteprednol etabonate/KPI-121) is a nanoparticle ocular corticosteroid formulation for the treatment of postoperative ocular inflammation and pain. Inveltys, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. In August 2018, the US FDA approved Inveltys, a twice-daily ocular corticosteroid, for the treatment of postoperative inflammation and pain after ocular surgery.

BromSite (bromfenac ophthalmic solution): Sun Pharmaceutical

BromSite is the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Sun Pharma acquired InSite Vision in November 2015 and commercialized BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016. In April 2016, the US FDA approved BromSite (bromfenac ophthalmic solution) 0.075% for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery

Acute Ocular Pain (AOP) Emerging Drugs

APP13007: Formosa Pharmaceuticals

APP13007 is a nanoparticle formulation of the corticosteroid clobetasol in development for the treatment of post-operative inflammation of the eye. Activus was originally developing APP13007 by applying its patented proprietary APNT (Activus Pure Nanoparticle Technology) to the corticosteroid clobetasol propionate to create a novel nanoparticle formulation for treating post-operative inflammation of the eye. In January 2021, Formosa Pharmaceuticals initiated a Phase III study.

Tivanisiran (SYL1001): Sylentis

Tivanisiran is a chemically synthesized small interference RNA (siRNA) inhibitor of the Transient Receptor Potential Vanilloid-1 (TRPV1) formulated as eye drops. This receptor is a nociceptor that maintains a dual function in corneal tissues participating in pain-sensing, transmission, and regulation and acting as a mediator of innate inflammatory response. These actions make it an ideal candidate for treating Dry eye disease (DED). Tivanisiran belongs to a new emerging drug class whose mechanism of action differs from traditional small-molecules. Non-clinical studies conducted by Sylentis with SYL1001 have demonstrated it has a high ability to inhibit this specific target and block the perception of ocular pain in animals. In June 2015, Sylentis initiated a Phase II study. This pilot study aimed to compare the analgesic effect of two strengths of SYL1001 eye drops versus placebo in patients with ocular pain associated with dry eye syndrome.

Aldeyra Therapeutics

Reproxalap represents a novel mechanism for diminishing ocular inflammation in dry eye disease, by inhibiting RASP, which are elevated in a variety of inflammatory diseases. In a number of clinical trials, reproxalap demonstrated consistent statistically significant and clinically relevant activity. Reactive aldehyde species (RASP) are reactive molecules that covalently bind to cellular biomolecules, disrupting their function and activating pro-inflammatory mediators. RASP are formed by a variety of processes, including lipid peroxidation, alcohol oxidation, polyamine, and glucose metabolism. In January 2021, Aldeyra Therapeutics initiated a phase III, multi-center, double-masked, randomized, vehicle-controlled, parallel-group clinical trial evaluating the safety of 0.25% Reproxalap ophthalmic solution in subjects with dry eye disease.

Acute Ocular Pain (AOP) Market Outlook

Eye pain is a myriad of symptoms ranging from a sharp pain in the eye to mild discomfort or itching in the eyes. As the spectrum of symptom presentation varies with eye pain, the cause of these pains may vary from very simple refractive errors to potentially sight-threatening disorders like glaucoma and uveitis. A feeling of discomfort or pain in the eye can be caused by a problem in the eye itself. It can also be caused by a problem involving any structures around the eye or referred pain from tissues with similar innervation as ocular tissues. Most ophthalmologic conditions producing ocular pains are associated with obvious ocular symptoms and signs like red-eye, photophobia, vision loss, or diplopia. Sometimes it poses a challenge to physicians when the pain is associated with a quiet eye or “white eye.”

Pain associated with surgery, injury, infection, or inflammation at the front of the eye is typically treated with a topical steroid, topical NSAID, systemic NSAID, lubricant ointment, gel or drops, bandage contact lens, or a few doses of oral opiate or topical anesthetic.

Recently various drugs such as Dextenza, Inveltys, BromSite, and Lotemax have been approved to treat ocular inflammation and pain following ophthalmic surgery and cataract surgery. Dextenza is the first FDA-approved intracanalicular insert, a novel route of administration that delivers the drug to the eye's surface without the need for eye drops. The drug is a preservative-free, resorbable hydrogel insert that delivers 0.4 mg of dexamethasone to treat postsurgical ocular inflammation and pain for up to 30 days with a single administration.

Key Findings

• The market size of Acute Ocular Pain (AOP) in the 7MM was estimated to be USD 276.02 million in 2020, and it is estimated to grow at a Compound Annual Growth Rate (CAGR) of 8.93% for the study period (2018-2030).
• According to the estimates, the highest market size of Acute Ocular Pain (AOP) was found in the United States, followed by Germany in the year 2020.
• The market size of AOP in the EU5 was estimated to be USD 89.18 million in 2020, and it is estimated to grow at a Compound Annual Growth Rate (CAGR) of 7.80% for the study period (2018-2030).
• Among the EU5 countries, Germany had the highest market size of AOP with USD 22.13 million in 2020, while Spain had the lowest market size for AOP with USD 13.06 million in 2020.
• Dextenza, Inveltys, and Lotemax SM - already approved in the US market - are expected to enter the European and Japan market in 2023, 2024, and 2024, respectively.

Currently NSAIDs, Steroids, and others (Antibiotics) are used to manage acute ocular pain. These therapies are further classified into monotherapies and combination therapies. In combination therapies, the combination of Antibiotics + Steroids, NSAIDS + Antibiotics + Steroids, and others (Antibiotics + NSAIDs; Steroids + NSAIDs) are prescribed by the physicians as off-label therapies to manage ocular pain.

Dextenza, Inveltys, and Lotemax SM are the recently approved drugs indicated for post-operative pain management of cataract surgery. All these three therapies were launched in the US market in 2019. The other upcoming therapies that are being investigated for pain management in the case of Cataract surgeries and Dry Eye Disease (DED) include, APP13007, Reproxalap, and Tivanisiran (SYL1001). Reproxalap and Tivanisiran (SYL1001) are the only upcoming therapies that will be targeting the DED patient pool, and hence will be competing with each other. In their clinical results, it was observed that the drugs were successfully able to manage pain in the case of DED.

Reproxalap is estimated to capture the largest market among the upcoming therapies because it will be targeting the overall patient pool of DED.”

The United States Market Outlook

This section provides the total AOP market size and market size by therapies in the United States.

EU-5 Market Outlook

The total AOP market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total AOP market size and market size by therapies in Japan are provided.

Acute Ocular Pain (AOP) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the AOP market or expected to get launched in the market during the study period 2018-2030. The analysis covers the AOP market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Acute Ocular Pain (AOP) Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for AOP emerging therapies.

Reimbursement Scenario in Acute Ocular Pain (AOP)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitive and market Intelligence analysis of the AOP market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of AOP, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the AOP epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for AOP is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the AOP market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM AOP market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA, increasing incidence, effectiveness of drugs as both mono and combination therapy will positively drive the AOP market.
• The companies and academics are working to assess challenges and seek opportunities that could influence AOP R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for AOP. The launch of emerging therapies will significantly impact the AOP market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Acute Ocular Pain (AOP) Report Insights

• Patient Population
• Therapeutic Approaches
• AOP Pipeline Analysis
• AOP Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Acute Ocular Pain (AOP) Report Key Strengths

• 10 Years Forecast
• 7MM Coverage

AOP Epidemiology Segmentation

• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Acute Ocular Pain (AOP) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

• What was the AOP market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the AOP total market size as well as market size by therapies across the 7MM during the forecast period (2021-2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest AOP market size during the forecast period (2021-2030)?
• At what CAGR, the AOP market is expected to grow at the 7MM level during the forecast period (2021-2030)?
• What would be the AOP market outlook across the 7MM during the forecast period (2021-2030)?
• What would be the AOP market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of AOP?
• What is the historical AOP patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of AOP at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to AOP?
• Out of the above-mentioned countries, which country would have the highest incident population of AOP during the forecast period (2021-2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021-2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of AOP along with the approved therapy?
• What are the current treatment guidelines for the treatment of AOP in the US and Europe?
• What are the AOP marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of AOP?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of AOP?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the AOP therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for AOP and their status?
• What are the key designations that have been granted for the emerging therapies for AOP?
• What are the 7MM historical and forecasted market of AOP?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving AOP.
• To understand the future market competition in the AOP market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for AOP in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the AOP market.
• To understand the future market competition in the AOP market.