Ocular Therapeutix, Inc. operates as a biopharmaceutical company committed to redefining the retina experience.
AXPAXLI (axitinib intravitreal hydrogel, also known as OTX-TKI), the company's product candidate for retinal disease, is based on the company's proprietary ELUTYX bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in two repeat-dosing Phase 3 clinical trials for the treatment of wet age-related macular degeneration, or wet AMD, which the company refers to as the...
Ocular Therapeutix, Inc. operates as a biopharmaceutical company committed to redefining the retina experience.
AXPAXLI (axitinib intravitreal hydrogel, also known as OTX-TKI), the company's product candidate for retinal disease, is based on the company's proprietary ELUTYX bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in two repeat-dosing Phase 3 clinical trials for the treatment of wet age-related macular degeneration, or wet AMD, which the company refers to as the SOL-1 and the SOL-R trials. The company has also completed a Phase 1 clinical trial of AXPAXLI for the treatment of non-proliferative diabetic retinopathy, or NPDR, which it refers to as the HELIOS trial. The company intends to meet with the U.S. Food and Drug Administration, or FDA, in the first half of 2025 to discuss the design of a potential registrational clinical program for AXPAXLI for the treatment of NPDR and diabetic macular edema, or DME, and then evaluate its next steps.
The company also leverages the ELUTYX technology in its commercial product DEXTENZA, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery, and for the treatment of ocular itching associated with allergic conjunctivitis, and its product candidate PAXTRAVA (travoprost intracameral hydrogel, also known as OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma, or OAG, or ocular hypertension, or OHT.
DEXTENZA and the company’s product candidates in clinical development generally incorporate therapeutic agents that have previously received regulatory approval from the FDA, including small molecules, into ELUTYX, with the goal of providing local programmed release to tailor the duration and amount of the therapeutic agent to be delivered to the eye.
The company's ELUTYX-based products and product candidates are hydrogels with ester bonds that are hydrolyzed over time by aqueous or vitreous humor fluid within the eye. Unlike traditional implants, the ELUTYX-based hydrogel is not rigid, does not have a shell, and does not persist following the dissolution of the active drug. The factors that regulate the bioresorption of the company's ELUTYX polymer are temperature and pH of the aqueous environment. As body temperature and pH of the human aqueous environment are within a typical range for humans, and since water levels in the aqueous or vitreous humor are more than sufficient to saturate the company's polymer matrix.
Strategy
The company’s strategy is to advance its pipeline of clinical assets, focusing specifically on its programs for wet AMD as well as NPDR and DME, while it continues to build upon its experience in commercializing ophthalmology products.
The key tactics of the company’s strategy are to advance its AXPAXLI clinical development programs; and scale up its commercialization and manufacturing capabilities.
Clinical Portfolio
Retinal Programs
AXPAXLI (axitinib intravitreal hydrogel)
The company's product candidate AXPAXLI is an investigational, bioresorbable hydrogel implant, based on its ELUTYX technology, incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor, or TKI, with anti-angiogenic properties. AXPAXLI is delivered by intravitreal injection and is designed for a duration of six months or longer. The company's wet AMD registrational program for AXPAXLI is comprises two ongoing complementary clinical trials, SOL-1 and SOL-R, which are strategically designed with the intent of de-risking subject populations, aligning with regulatory standards, and providing a broad evaluation of AXPAXLI’s durability, repeatability, and flexibility. The company has also conducted a Phase 1 clinical trial in Australia and a Phase 1 clinical trial in the United States to evaluate AXPAXLI for the treatment of wet AMD. It has completed the HELIOS trial to evaluate AXPAXLI for the treatment of NPDR. The company intends to meet with the FDA in the first half of 2025 to discuss the design of a potential registrational clinical program for AXPAXLI for the treatment of NPDR and DME, and then evaluate its next steps.
The company conducted the two Phase 1 trials of AXPAXLI for the treatment of wet AMD with different formulations of axitinib. The company is conducting the SOL-1 and SOL-R trials with a single 450 µg axitinib dose of AXPAXLI, which is a different formulation than it used in either of the two Phase 1 trials of AXPAXLI for the treatment of wet AMD.
The two Phase 1 trials of AXPAXLI for the treatment of wet AMD, the HELIOS trial, and the initial portions of the SOL-1 and SOL-R trials were conducted with a two-piece injector.
The company expects to use this one-piece injector for the administration of AXPAXLI in a majority of the subjects in the AXPAXLI arm of the SOL-R trial, and for the repeat dosing of AXPAXLI in all subjects in the AXPAXLI arm of the SOL-1 trial.
Wet Age-Related Macular Degeneration (Wet AMD)
The SOL-1 Trial
The company is conducting the SOL-1 trial, a repeat-dosing registrational Phase 3 clinical trial for the treatment of wet AMD. The SOL-1 trial is designed as a prospective, multi-center, randomized, parallel-group trial that involves more than 100 trial sites located in the United States and Argentina. The SOL-1 trial is designed as a superiority trial comparing a single optimized dose of AXPAXLI with a drug load of 450 µg of axitinib to a single injection of aflibercept 2 mg and assessing the safety and efficacy of AXPAXLI in subjects with wet AMD.
The company is conducting the SOL-1 trial in accordance with a Special Protocol Assessment, or SPA, agreement with the FDA. It initially sought an SPA agreement from the FDA to determine whether the proposed clinical protocol and the statistical analysis plan for the SOL-1 trial adequately addressed scientific and regulatory requirements for a clinical trial that could support a marketing application. The company received an agreement letter regarding the overall trial design from the FDA under the SPA agreement on October 30, 2023.
As of March 3, 2025, subject retention in the SOL-1 trial has been exceptional, and the vast majority of rescue treatments, reviewed on a masked basis, have been in accordance with pre-specified criteria under the trial protocol. Because the inclusion of re-dosing requires all data to be masked until week 52, the company now expects topline results for SOL-1 to be available in the first quarter of 2026.
The SOL-R Trial
In June 2024, the company initiated the SOL-R trial, a repeat-dosing registrational Phase 3 clinical trial for the treatment of wet AMD. The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial that will involve sites located in the U.S. and the rest of the world. The trial is intended to randomize approximately 555 subjects that are either treatment naïve or have been diagnosed with wet AMD in the study eye within the prior four months and received up to three monthly anti-VEGF injections with last injection approximately 4 weeks prior to screening for SOL-R. Prior to the second SPA amendment and inclusion of re-dosing in SOL-1 as described above, the company previously intended to randomize 825 subjects in the SOL-R trial.
On November 14, 2024, the company announced that, as the SOL-1 trial neared completion of randomization, trial sites could directly screen and enroll eligible subjects into the SOL-R trial.
On January 14, 2025, the company announced that, as of January 10, 2025, it had enrolled 311 subjects across various stages of loading and randomization. All subjects that have been randomized to date have received their first 450 µg dose of AXPAXLI at Day 1 with the 2-piece injector.
Phase 1 Clinical Trial (Australia)
The company has conducted an open-label, multi-center, proof-of-concept, dose-escalation Phase 1 clinical trial of AXPAXLI for the treatment of patients with wet AMD. This Phase 1 clinical trial was designed to evaluate the safety, durability, and tolerability of AXPAXLI. All subjects have completed this Phase 1 clinical trial.
The company’s Phase 1 clinical trial of AXPAXLI in Australia was submitted to the Therapeutic Goods Administration, Australia’s regulatory authority for therapeutic goods, in July 2018 and was being conducted at multiple sites in Australia. The Phase 1 clinical trial was comprises four cohorts consisting of subjects with wet AMD and pre-existing intraretinal and/or subretinal fluid: a lower dose cohort of 200 µg with six subjects; a higher dose cohort of 400 µg with seven subjects; a third cohort with two parallel arms, one arm of four subjects receiving a concomitant anti-VEGF injection with 400 µg of AXPAXLI and the other arm of six subjects receiving a 600 µg of AXPAXLI with no anti-VEGF injection; and a fourth cohort with two parallel arms, one arm of one subject receiving a 600 µg single dose of AXPAXLI and the other arm of five subjects receiving a 600 µg single dose of AXPAXLI with anti-VEGF injection. In this trial, the company evaluated whether AXPAXLI can reduce existing fluid levels.
In the Phase 1 clinical trial of AXPAXLI conducted in Australia, the company evaluated biological activity by measuring CSFT, using spectral domain optical coherence tomography, or OCT, and following visual acuity over time as measured by BCVA.
In addition, the AXPAXLI doses in cohort 1 (200 µg single dose) were observed to have biodegraded in all subjects within nine to 10.5 months of injection. It has also been observed in the trial that the hydrogels were able to be adequately monitored and that there was limited to no movement of the hydrogel and no migration into the anterior chamber has occurred.
Phase 1 Clinical Trial (United States)
The company has conducted a prospective, multi-center, randomized, controlled Phase 1 clinical trial in the United States under an exploratory investigational new drug, or eIND, application to evaluate a single 600 µg dose of AXPAXLI with an anti-VEGF injection in comparison with a 2 mg dose of aflibercept. The population it studied in this U.S.-based clinical trial was different from the population it studied in the company's Phase 1 clinical trial of AXPAXLI in Australia. In this trial, the company evaluated how long it is able to maintain subjects who have been previously treated with anti-VEGF therapy without the need for retreatment. All enrolled subjects have completed this Phase 1 clinical trial.
In February 2023, the company announced interim 10-month data from the Phase 1 clinical trial of AXPAXLI in the United States at the Angiogenesis, Exudation, and Degeneration 2023 Annual Meeting. As of the December 12, 2022 cut-off date, the interim data showed that the single 600 µg AXPAXLI dose was generally well tolerated with no drug-related ocular or systemic serious adverse events, or SAEs, observed through 10 months.
In April 2023, the company presented data regarding the preclinical pharmacokinetics, or PK, of AXPAXLI and a review of the 10-month interim data from the ongoing Phase 1 clinical trial of AXPAXLI in the United States, including AXPAXLI resorption data to date.
In June 2023, the company presented 12-month data from the ongoing Phase 1 clinical trial of AXPAXLI in the United States at the Clinical Trials at the Summit 2023 conference sponsored by the American Society of Retina Specialists. As of the April 14, 2023 cut-off date, there were no drug-related ocular or systemic SAEs observed in the AXPAXLI arm except for the one SAE of endophthalmitis following the aflibercept injection at month 1 that it had previously announced. There were no retinal detachment, retinal vasculitis, or hydrogel implant migration into the anterior chamber adverse events observed in the AXPAXLI arm, and no subjects had dropped out of either arm as of the data cut-off.
Non-Proliferative Diabetic Retinopathy (NPDR)
Phase 1 Clinical Trial
The company has completed the HELIOS trial, a U.S.-based, multicenter, double-masked, randomized, parallel group Phase 1 clinical trial evaluating the safety, tolerability, and efficacy of a single injection of an AXPAXLI 600 µg dose in subjects with moderately severe to severe NPDR without CI-DME. The company conducted the HELIOS trial initially under an exploratory IND, which was subsequently converted to a traditional IND.
In June 2024, the company announced topline data from the HELIOS trial at 48 weeks. AXPAXLI was generally well-tolerated and did not result in any reported incidence of intraocular inflammation, iritis, vitritis, or vasculitis.
The company intends to meet with the FDA in the first half of 2025 to discuss the design of a potential registrational clinical program for AXPAXLI for the treatment of NPDR and DME, and then evaluate its next steps.
Glaucoma Program
PAXTRAVA (travoprost intracameral hydrogel)
The company’s product candidate PAXTRAVA is a bioresorbable hydrogel implant based on ELUTYX, incorporating travoprost, an FDA-approved PGA designed to lower elevated IOP, that is designed to be administered by a physician as an intracameral injection with an initial target duration of drug release of four to six months with a single treatment.
Phase 2 Clinical Trial
The company is conducting a U.S.-based Phase 2 prospective, multi-center, randomized, controlled clinical trial evaluating the safety, tolerability and efficacy of PAXTRAVA for the treatment of subjects with primary OAG or OHT under an IND. The Phase 2 clinical trial was initially designed to include approximately 105 subjects at 15 to 20 sites between three arms of approximately 35 subjects each to evaluate two formulations of PAXTRAVA for the treatment of OAG or OHT in subjects compared to DURYSTA.
The company initiated the Phase 2 clinical trial in the fourth quarter of 2021 and dosed the first subject in the first quarter of 2022. One arm in the Phase 2 clinical trial is receiving the same formulation used in cohort 2 of the Phase 1 clinical trial of PAXTRAVA that it conducted, containing a 26 µg dose of travoprost and utilizing a standard hydrogel. The second arm was receiving the same formulation used in cohort 4 of the Phase 1 clinical trial, containing a 5 µg dose of drug and utilizing a fast-degrading hydrogel. Due to elevations in IOP observed in six subjects approximately 12 weeks after enrollment in the PAXTRAVA 5 µg arm of the trial, the company terminated enrollment in the 5 µg arm of the trial in the fourth quarter of 2022 and continued with the PAXTRAVA 26 µg and DURYSTA arms of the trial.
The company is conducting a pilot repeat-dose sub-study in the Phase 2 clinical trial to evaluate the safety of a repeat, sustained release dose of PAXTRAVA 26 µg, in a small subset of subjects with OAG or OHT. These subjects will be followed for at least six months after their enrollment in the sub-study to monitor and evaluate their endothelial cell health.
Phase 1 Clinical Development
The company submitted an IND for PAXTRAVA in February 2018 and have completed a prospective, multi-center, open-label, dose-escalation, proof-of-concept Phase 1 clinical trial of PAXTRAVA in the United States that it initiated in the second quarter of 2018 for the treatment of subjects with moderate to severe glaucoma or OHT. The clinical trial is designed to evaluate the safety, biological activity, durability and tolerability of PAXTRAVA in subjects with controlled OAG or OHT.
In February 2022, at the Glaucoma 360 virtual meeting, the company presented interim results from all four subject cohorts in the Phase 1 clinical trial.
Once the company has completed the pilot repeat-dose sub-study, it will evaluate whether an end-of-Phase 2 meeting with the FDA is appropriate for determining its next steps for PAXTRAVA for the treatment of OAG or OHT.
The Ocular Therapeutix Approach
Hydrogel-Based Formulation Technology ELUTYX
The company applies its expertise with ELUTYX to the development of products for local programmed-release of known, FDA-approved therapeutic agents for a variety of ophthalmic diseases and conditions and to ophthalmic wound closure.
The company's technical capabilities include a deep understanding of the polymer chemistry of PEG-based hydrogels and the design of the highly specialized manufacturing processes required to achieve a reliable, preservative-free, and pure product. It tailors the hydrogel to act as a vehicle for local programmed-release drug delivery to the eye and as an ocular tissue sealant.
The company creates its hydrogels by cross-linking PEG molecules to form a network that resembles a three-dimensional mesh on a molecular level. The company's PEG molecules are branched, with four to eight branches or arms. Each arm bears a reactive site on its end. The company’s cross-linking chemistry uses a second molecule with multiple arms, bearing complementary reactive sites on each end, such that when combined with the PEG molecules, a network spontaneously forms. When swollen with water, this molecular network forms a hydrogel. The company designs these hydrogels to slowly degrade in the presence of water, a process called hydrolysis, by inserting a biodegradable linkage between the PEG molecule and the cross-linked molecule. By appropriately selecting the number of arms of the PEG molecule and the biodegradable linkage, it can design hydrogels with varying mechanical properties and bioresorption rates. Because the body has an abundance of water at a constant temperature and pH level, hydrolysis provides a predictable and reproducible degradation rate. The company's technology enables it to make hydrogels that can bioresorb over days, weeks, or months.
The company selects the active pharmaceutical ingredients for its local programmed-release drug delivery product candidates based on criteria it has developed through its extensive experience with hydrogel-based technologies.
Intravitreal Hydrogels
The company is engaged in the clinical development of its hydrogel administered via intravitreal injection to address the large and growing markets for diseases and conditions of the back of the eye. Its intravitreal hydrogel product candidates, such as AXPAXLI, consist of a PEG-based hydrogel, which contains embedded micronized particles of active drug. The company designs the intravitreal hydrogel to be injected and retained in the vitreous humor to provide local programmed-release intravitreal delivery of anti-VEGF compounds.
Intracameral Hydrogels
The company is engaged in the clinical development of its hydrogel administered via intracameral injection to address glaucoma. Intracameral hydrogels refer to biodegradable or bioresorbable hydrogels placed into the anterior chamber or front of the eye for the treatment of ocular conditions. The hydrogels are designed to be held in place by currents and gravity present in the anterior chamber of the eye. In the case of PAXTRAVA, the hydrogel is designed to infuse with intracameral water, settle into the inferior angle of the eye, and demonstrate little to no movement. The hydrogels are soft, biodegradable, and provide sustained release of at least one therapeutic agent to both the trabecular meshwork and associated ocular tissue, and the fluids within the anterior chamber of the eye.
Intracanalicular Inserts
The company's intracanalicular inserts, including DEXTENZA, are designed to be inserted into the patient’s punctum by a healthcare professional and to release drug to the surface of the eye to address diseases, including ocular inflammation and pain following ophthalmic surgery, as well as ocular itching associated with allergic conjunctivitis.
The company's intracanalicular inserts utilize ELUTYX and are embedded with an active drug. Following insertion through the punctum, the inserts swell in tear fluid to fill the vertical canaliculus, which secures the inserts in place. Over time, the inserts liquefy and are cleared through the nasolacrimal duct.
Commercial Portfolio
Post-Surgical Ocular Inflammation and Pain
DEXTENZA (dexamethasone intracanalicular insert)
DEXTENZA incorporates the FDA-approved corticosteroid dexamethasone as a preservative-free active pharmaceutical ingredient into a drug-eluting intracanalicular insert that is based on ELUTYX. Following FDA approval, the company commercially launched DEXTENZA for the treatment of post-surgical inflammation and pain in July 2019. DEXTENZA is the first and only FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular inflammation and pain for up to 30 days with a single administration.
The company selected dexamethasone as the active pharmaceutical ingredient for DEXTENZA because it is approved by the FDA and has a long history of ophthalmic use; is available on a generic basis from multiple qualified suppliers; is highly potent and is typically prescribed for prevention of ocular inflammation and pain following ocular surgery; and has physical properties that are well suited for incorporation within its hydrogel technology.
The dexamethasone drug particles embedded within its DEXTENZA intracanalicular insert gradually erode and release the drug in a programmed fashion until the drug is depleted. As the dexamethasone drug particles erode and the ELUTYX degrades by hydrolysis, the intracanalicular insert softens, liquefies and is cleared through the nasolacrimal duct. The company provides the DEXTENZA drug product in a preservative-free formulation in a sterile, single use package.
Investigator-Initiated Trials
The company has received proposals for, and are supporting, several investigator-initiated trials evaluating DEXTENZA in different clinical situations. To date, third-party clinical investigators have initiated 45 trials to study the use of DEXTENZA in cataract surgery, other ophthalmic surgeries, and other potential indications. Of those, 21 trials have published study reports, and 14 trials have been terminated. The remaining 10 trials are in various stages of enrollment and treatment.
Post-Approval Studies
In September 2020, the company announced that it had dosed the first pediatric subjects in a U.S.-based, randomized, multicenter Phase 3 clinical trial evaluating DEXTENZA for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery. This clinical trial is a post-approval requirement of the FDA in accordance with the Pediatric Research Equity Act of 2003, in connection with the FDA’s prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery in adults. It is designed to evaluate the safety of DEXTENZA compared to an active control, prednisolone acetate suspension eye drops, for the treatment of inflammation and pain following ocular surgery for pediatric cataract in children between zero and five years of age. The FDA has agreed that this Phase 3 clinical trial evaluating DEXTENZA for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery may also satisfy the post-approval requirement for a pediatric trial as it relates to the indication for ocular itching associated with allergic conjunctivitis.
In June 2024, the company submitted the data for its clinical trial to evaluate DEXTENZA in pediatric subjects following cataract surgery, along with the updated package insert, to the FDA. The company anticipates receiving the FDA’s decision on the pediatric labeling for DEXTENZA during the second quarter of 2025.
Foreign Approvals
Outside the United States, the company continue to assess whether to seek regulatory approval for DEXTENZA in markets, such as the European Union, Australia and Japan based on the market opportunity, particularly pricing, and the requirements for marketing approval. Given the company’s prioritization of the clinical development of its sustained-release product candidates, in particular for retinal diseases, and the company’s planned commercialization efforts for its initial intracanalicular insert product candidates in the United States, it expects it will need to engage third parties to assist the company in the approval process.
The company has entered into a license agreement and collaboration with AffaMed for the development and commercialization of DEXTENZA, along with PAXTRAVA in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations, or the AffaMed License Agreement. In January 2022, AffaMed dosed its first subject in a study conducted in China evaluating the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain post-cataract surgery.
In April 2023, AffaMed announced that China’s National Medical Products Administration, or NMPA, had approved AffaMed’s Clinical Trial Application to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery, or the Phase 3 Registrational Study. In September 2023, AffaMed announced that the first subject had been treated in the Phase 3 Registrational Study.
In February 2024, AffaMed announced that the Singapore Health Sciences Authority has accepted AffaMed’s new drug application for DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis for evaluation. In April 2022, AffaMed announced that DEXTENZA has been approved in Macau, China for the treatment of ocular inflammation and pain following ophthalmic surgery.
The company retains the right to develop and commercialize DEXTENZA in all other global markets. From time to time, it may consider additional arrangements with other companies to address markets outside of the United States. If the company or its collaborators obtain regulatory approval to market and sell DEXTENZA in international markets, it expects to utilize a variety of collaboration, distribution, and other marketing arrangements with one or more third parties to commercialize DEXTENZA.
Allergic Conjunctivitis
DEXTENZA (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
In October 2021, the FDA approved the company's supplemental New Drug Application, or sNDA, for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional indication. With the approval, DEXTENZA became the first FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days. DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis also represents the company's first indication approved to be administered in a physician’s office during a routine, non-surgical appointment.
Although dexamethasone is clinically effective in the treatment of late-phase inflammatory allergic reactions, the safety limitations associated with eye drop administration, including the potential to generate spikes in IOP due to the high levels of drug due to potential patient abuse to treat this symptomatic condition, have limited its widespread adoption. These elevations in IOP can lead to drug-induced glaucoma, although the incidence is low. Further, use of oral antihistamine medications, as well as anti-histamine eye drops for allergic conjunctivitis may dry out the eye and exacerbate the discomfort to some patients.
AffaMed License Agreement
The company agreed to grant AffaMed exclusive rights to develop and commercialize DEXTENZA for the treatment of post-surgical inflammation and pain following ophthalmic surgery, as well as for ocular itching in patients with allergic conjunctivitis, and PAXTRAVA for the reduction of elevated IOP in patients with primary OAG or OHT in specified Asian markets. The company retains the right to develop and commercialize DEXTENZA and PAXTRAVA in all other global markets.
Sales, Marketing and Distribution
The company sells DEXTENZA in the United States to specialty distributors, or SDs, for resale to certain ambulatory surgery centers, or ASCs, certain hospital outpatient departments, or HOPDs, and certain physicians’ offices, as well as directly to certain ASCs and physicians’ offices. The company is continuing to offer this distribution option more broadly to its end customers.
In addition to distribution agreements with specialty distributors and a small number of ASCs and physicians’ offices, the company enters into arrangements with government payors that provide for government-mandated rebates and chargebacks with respect to the purchase of DEXTENZA. The company has built a highly targeted, key account sales force of KAMs, or key account managers, Regional Directors, and FRMs, or field reimbursement managers, that focus on the ASCs and their affiliates responsible for the largest volumes of cataract surgery in the United States, with an initial emphasis on the approximately two million cataract procedures performed annually under Medicare Part B.
The company focuses its sales efforts on sales to ASCs and strategic accounts that own and control multiple ASCs. In the first quarter of 2023, the company launched a Commercial Assurance Program to provide assistance with patients’ out-of-pocket costs, supporting the expansion of DEXTENZA for commercially insured patients not covered by government payors.
Intellectual Property
As of December 31, 2024, the company owned or exclusively licensed in certain fields of use over 300 issued U.S. patents, pending U.S. patent applications, issued foreign patents, and pending foreign patent applications.
Certain of the company's U.S. patents and applications, and foreign counterparts, are owned by it and other U.S. patents and applications, and their foreign counterparts have been in-licensed from Incept.
The following is a summary of patents and patent applications that cover the company's commercial products and potentially cover its product candidates:
AXPAXLI (axitinib intravitreal hydrogel)
The company owns issued patents in the United States and patents in certain foreign jurisdictions that cover this product candidate, with current expiration dates in 2041. The company owns a pending Patent Cooperation Treaty application with the potential to cover this product candidate in the U.S. and foreign jurisdictions, that, if granted, is expected to expire in 2044. Additional U.S. and foreign patent applications are pending.
PAXTRAVA (travoprost intracameral hydrogel) for the treatment of OAG or OHT
The company has licenses to a U.S. patent, and certain foreign counterparts, with current expiration dates in 2037, along with corresponding pending U.S. and foreign counterparts. The company owns an issued patent in the United States and patents in certain foreign jurisdictions that cover this product candidate, with current expiration dates in 2041. Additional owned U.S. and foreign patent applications are pending.
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg
The company has licenses to U.S. patents, and certain foreign counterparts, with current expiration dates in 2030 that cover this product. The company also owns two U.S. patents that cover this product, with current expiration dates in 2036 and 2037, along with a pending U.S. patent application.
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the treatment of allergic conjunctivitis
The company has licenses to U.S. patents, and certain foreign counterparts, with current expiration dates in 2030 that cover this product. The company also owns two U.S. patents that cover this product, with current expiration dates in 2036 and 2037. The company also owns an issued U.S. patent expiring in 2041, along with related pending U.S. and foreign applications.
Licenses
Incept, LLC
In January 2012, the company entered into an amended and restated license agreement, which it refers to as either the Prior Agreement or Original License, with Incept, under which the company holds an exclusive, worldwide, perpetual, irrevocable license under specified patents and technology owned or controlled by Incept to make, have made, use, offer for sale, sell, sublicense, have sublicensed, offer for sublicense, and import products delivered to or around the human eye for diagnostic, therapeutic, or prophylactic purposes relating to all human ophthalmic diseases or conditions. This license covers a significant portion of the patent rights and the technology for DEXTENZA, ReSure Sealant, and the company's hydrogel platform technology product candidates.
On September 13, 2018, or the Effective Date, the company entered into a second amended and restated license agreement, or the Second Amended Agreement, with Incept. The Second Amended Agreement amends and restates in full the Prior Agreement, to expand the scope of the company's intellectual property license and modify future intellectual property ownership and other rights thereunder.
AffaMed License Agreement
On October 29, 2020, the company entered into the AffaMed License Agreement with AffaMed for the development and commercialization of DEXTENZA regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis, or collectively, the DEXTENZA Field, and for PAXTRAVA, or collectively with DEXTENZA, the AffaMed Licensed Products, regarding OAG and OHT, or collectively, the TIC Field and, with the DEXTENZA Field, each a Field, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations, or collectively, the Territories. The company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.
Research and Development
The company's research and development expenses were $127.6 million for the year ended December 31, 2024.
Government Regulation
The company’s clinical trials are regulated by the Common Rule, which also includes specific privacy-related provisions.
History
Ocular Therapeutix, Inc. was founded in 2006. The company was incorporated under the laws of the state of Delaware in 2006.
