ISTA Pharmaceuticals is a commercial stage, multi-specialty pharmaceutical company developing, marketing and selling our own products in the United States. We manufacture our products through third party contracts, and we in-license or acquire new technology to add to our internal development efforts from time to time.
Our products and product candidates seek to treat serious diseases of the eye and allergies, and include therapies for ocular inflammation and pain, glaucoma, dry eye and ocular and nasal allergies. The U.S. prescription markets our therapies seek to address include key segments of the $5.5 billion ophthalmic pharmaceutical market and the $2.2 billion nasal allergy market.
We currently have four products available for sale in the United States and Puerto Rico: Xibrom (bromfenac sodium ophthalmic solution) for the treatment of inflammation and pain following cataract surgery, Bepreve (bepotastine besilate ophthalmic solution) for the treatment of ocular itching associated with allergic conjunctivitis, Istalol (timolol maleate ophthalmic solution) for the treatment of glaucoma, and Vitrase (hyaluronidase for injection) for use as a spreading agent.
We have incurred losses since inception and had an accumulated deficit of $397.3 million (including a non-cash valuation warrant adjustment of $52.1 million) through December 31, 2009.
Xibrom is a twice-daily topical non-steroidal anti-inflammatory formulation of bromfenac for the treatment of ocular inflammation and pain following cataract surgery. We received approval from the FDA for Xibrom for the treatment of ocular inflammation following cataract surgery in March 2005. We launched Xibrom in the United States in the second quarter of 2005. In January 2006, we received FDA approval of an expanded indication of Xibrom to include the treatment of pain following cataract surgery. We promote Xibrom through our own sales force.
Xibrom was first developed by Senju Pharmaceuticals, Co. Ltd., or Senju, and launched in Japan in 2000. In May 2002, we acquired marketing rights for Xibrom in the United States under a license agreement with Senju. In December 2009, we expanded the marketing rights to include not only the United States and its possessions, but also Canada and Mexico.
Based upon 2009 data from IMS Health, we estimate that 2009 sales in the U.S. topical ophthalmic non-steroidal anti-inflammatory market were approximately $326 million, with total prescriptions of 2.7 million. From 2008 to 2009, the U.S. topical ophthalmic non-steroidal anti-inflammatory market grew approximately 28% in dollars and 7% in total prescriptions. Certain other non-steroid treatments currently available must be dosed two, three or four times a day as compared to Xibrom’s twice-daily dosing.
In January 2009, the patent on Xibrom expired, exposing us to potential future generic competition. Most companies that manufacture drug substances file a Drug Master File, or DMF, with the FDA. These DMFs contain information on the manufacture and quality control of those drug substances.
Most companies that file abbreviated New Drug Applications, or ANDAs, to gain approval to market a generic version of a previously patented pharmaceutical product will reference a DMF for the drug substance contained in the product. In July 2009, a new DMF was filed for bromfenac, the drug substance in Xibrom. Based upon publicly available information on the average FDA review times for ANDAs, we do not anticipate a generic form of bromfenac to gain approval by a competitor until 2011, or later.
For the year ended December 31, 2009, sales of Xibrom accounted for 73% of our total net revenues. We believe that sales of Xibrom will continue to be a significant portion of our total net revenues in 2010.
In December 2009, we announced that we submitted an sNDA to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery. See “XiDay (bromfenac sodium ophthalmic solution) 0.09% - once-daily” below for further information.
Bepreve (bepotastine besilate ophthalmic solution) 1.5%
Bepreve is a twice-daily prescription treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older. In September 2009, we received approval from the FDA for, and launched, Bepreve in the United States. We promote Bepreve through our own sales force to ophthalmologists, optometrists and allergists.
Bepreve was first approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered the utility of bepotastine. In 2001, Tanabe Seiyaku granted Senju exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use.
In 2006, we licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, we licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
Based upon 2009 data from IMS Health, we estimate that 2009 sales in the U.S. ocular allergy market were approximately $594 million, with total prescriptions of 6.6 million. From 2008 to 2009, the U.S. ocular allergy market grew approximately 6% in total dollars and remained flat in total prescriptions.
Istalol is our once-daily eye drop solution of timolol, a beta-blocking agent for the treatment of glaucoma. Istalol was developed by Senju in Japan. In May 2002, we acquired marketing rights for Istalol in the United States under a license agreement with Senju.
We received FDA approval to market Istalol in the United States in 2004 for the treatment of glaucoma. We promote Istalol through our own sales force.
Glaucoma is a chronic disease that gradually reduces eyesight without warning and often without symptoms. If undetected and untreated, glaucoma can lead to irreversible eye damage and eventual blindness. According to the Glaucoma Research Foundation, glaucoma is the cause of an estimated 9-12% of all blindness cases and is the second leading cause of blindness in the United States. Currently, its causes are not well understood and there is no known cure.
According to the Glaucoma Research Foundation, four million people in the United States suffer from the disease, with 120,000 new cases documented annually. According to prescription data compiled by IMS Health for 2009, we estimate that the U.S. pharmaceutical market for the treatment of glaucoma exceeds $1.9 billion per year. Of this amount, the ophthalmic beta-blocker market was approximately $173 million in 2009, primarily at generic prices, with over 4.4 million prescriptions written in 2009. Timolol maleate, which is currently available from several manufacturers in either a twice-daily eye drop solution or once-daily gel formulation, is the leading beta-blocker to treat glaucoma in the United States. Istalol, given once-daily, has shown efficacy and safety comparable to timolol maleate solution, given twice-daily. Other than Istalol, the only available formulations of timolol maleate that have demonstrated efficacy with once-daily dosing are gels, which have been known to cause blurring of patients’ vision.
Vitrase (ovine hyaluronidase)
We launched Vitrase, our proprietary formulation of ovine hyaluronidase, for use as a spreading agent in 2005. The term hyaluronidase describes a group of naturally occurring enzymes that can digest certain forms of carbohydrate molecules called proteoglycans. Vitrase, when used as a spreading agent, is injected into connective tissue, where it modifies the permeability of such tissues and promotes diffusion of injected drugs, thus accelerating their absorption.
In May 2004, the FDA approved our NDA for Vitrase, in a lyophilized 6,200 USP units multi-purpose vial, for use as a spreading agent to facilitate the absorption and dispersion of other injected drugs. In October 2004, the FDA informed us that Vitrase for use as a spreading agent was entitled to five-year new chemical market exclusivity under the federal Food, Drug and Cosmetic Act. In September 2009, we announced the discontinuation of Vitrase, lyophilized 6,200 USP units multi-purpose vial.
In December 2004, the FDA approved our sNDA for Vitrase for use as a spreading agent at a concentration of 200 USP units/mL in sterile solution. We continue to sell our 200 USP units/mL vial of Vitrase through our own sales force.
XiDay (bromfenac sodium ophthalmic solution) 0.09% – once-daily
We are developing a once-daily version of Xibrom, or XiDay, for the treatment of ocular inflammation and pain following cataract surgery. In August 2009, we announced positive preliminary Phase III results from our XiDay Phase III confirmatory clinical study. XiDay achieved statistical significance in the study’s primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. In December 2009 we filed a sNDA with the FDA seeking approval of the XiDay formulation for once-daily treatment for the inflammation and pain following cataract surgery. We expect to be notified by the FDA by the end of February or early March 2010 about the Prescription Drug User Fee Act, or PDUFA, date.
T-Pred (tobramycin and prednisolone acetate combination product)
T-Pred is our proprietary formulation of a fixed combination product of tobramycin 0.3% and prednisolone acetate 1.0%. T-Pred is being developed for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.
T-Pred, if approved by the FDA, will compete in the antibiotic/steroid combination segment of the U.S. topical ophthalmic anti-inflammatory market. Based upon management estimates and 2009 prescription data compiled by IMS Health, we estimate that 2009 sales in the U.S. topical ophthalmic anti-inflammatory market were approximately $753 million, with total prescriptions of 10.8 million. In 2009, the combination antibiotic and steroid segment of the ophthalmic anti-inflammatory market had approximately a 37% share of the prescriptions or $272 million in prescription dollars and about 3.9 million prescriptions according to data compiled by IMS Health. Assuming approval by the FDA, we plan to promote this product with our own sales force.
In February 2006, we announced positive results from our Phase III bioequivalence study of T-Pred for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.
In July 2006, we submitted to the FDA an NDA for T-Pred for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.
In May 2007, we received a not approvable letter from the FDA. The FDA assessed our clinical data and found that it did not show sufficient equivalence between the prednisolone component in T-Pred and PredForte at least at one of the time points measured. In addition, the FDA found that our clinical data did not show sufficient equivalence in the kill time between the tobramycin components in T-Pred and Tobrex®, although it did show equivalence versus Zylet® and Tobradex®. After further discussions with the FDA, we initiated an additional clinical study and in vitro work to address the issues raised by the FDA.
In September 2009 we announced the preliminary results from two completed studies. In the first study, we evaluated the antimicrobial equivalence between T-Pred and a tobramycin-containing reference product. We successfully demonstrated the antimicrobial bioequivalence of T-Pred to the reference product in each of the 26 required tests. The second study was a Phase 3 clinical study designed to determine the bioequivalence of prednisolone concentrations between T-Pred and a reference product containing prednisolone acetate 1.0%. Although T-Pred’s prednisolone concentrations in this study were similar to those of the reference product, bioequivalence was not demonstrated. We believe differences in the prednisolone reference product, which included a higher drug concentration in the formulation and a recent change in the commercial product delivery dose of the reference product, may have contributed to the variations in study results between the two products. We are discussing the study results with the FDA to determine the best path forward for T-Pred and determining the appropriate clinical study or studies to perform in lieu of an additional prednisolone bioequivalence study, although no further clinical studies are planned for 2010.
Bromfenac – lower concentration
We are developing a lower concentration of bromfenac for the treatment of dry eye syndrome. According to the National Eye Institute, dry eye syndrome, which is also referred to as keratoconjunctivities sicca, or KCS, is defined as a disorder of the tear film due to the tear deficiency or excessive tear evaporation which causes damage to the interpalpebral, or the exposed area between the upper and lower eye lids, ocular surface and is associated with symptoms of ocular discomfort. Dry eye syndrome has been linked with a number of factors, including age, hormonal changes, ocular disease, medications that disrupt tear secretion or blinking, and autoimmune diseases such as lupus and rheumatoid arthritis. In severe cases of dry eye syndrome, scarring develops that may lead to blindness. Based on data compiled from various publicly available sources, we estimate that annual sales in the U.S. prescription dry eye market were approximately $502 million in 2009, with total prescriptions of over 2.5 million.
In June 2009, we announced positive results from a proof-of-concept Phase II clinical study in subjects with dry eye disease. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining as compared to baseline. Patients also achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index and improvements in patients’ most bothersome ocular symptoms.
We plan to initiate Phase III studies with bromfenac for the treatment of dry eye syndrome, which could start in the first half of 2010.
We are developing ecabet sodium as a prescription eye drop for the treatment of dry eye syndrome. Ecabet sodium represents a new class of molecules that increases the quantity and quality of mucin produced by conjunctival goblet cells and corneal epithelia. Mucin is a glycoprotein component of tear film that lubricates while retarding moisture loss from tear evaporation. Ecabet sodium is currently marketed in Japan as an oral agent for treatment of gastric ulcers and gastritis. In November 2004, we acquired U.S. marketing rights to ecabet sodium for the treatment of dry eye syndrome in the United States under a license agreement with Senju.
In February 2006, we announced positive preliminary results from our U.S. randomized, three-arm (placebo/3.0%/3.9%) Phase IIb clinical study of ecabet sodium for the treatment of dry eye syndrome. The preliminary results of our Phase IIb study demonstrated a strong trend in efficacy for the lower (3%) dose with respect to ecabet sodium’s ability to address two objective signs of dry eye syndrome: corneal staining and blink rate. In addition, patients treated with the lower dose of ecabet sodium reported positive trends for reductions in symptoms as measured by an objective assessment using the Ocular Symptom Disease Index, or OSDI, and a subjective assessment of patients’ most bothersome symptom. In the preliminary results, no efficacy trends versus placebo were observed with respect to the higher (3.9%) dose. In addition, preliminary findings from our Phase IIb study suggested a favorable safety profile for ecabet sodium for the treatment of dry eye syndrome.
During the third quarter of 2006, we initiated a 100 patient Phase IIb confirmatory study designed to finalize the entry criteria and other clinical parameters for future registration studies. In May 2007, we announced positive results from the preliminary analysis of our Phase IIb confirmatory study of ecabet sodium. Patients in the ecabet sodium group achieved a strong trend in the objective sign of blink rate. In addition, patients in the ecabet sodium group reported a strong trend in the OSDI and a positive trend in the subjective assessment of patients’ most bothersome symptom. Strong and positive trends are used to confirm observations from previous clinical ecabet sodium studies and to serve as indicators of potential efficacy endpoints in Phase III studies. While our Phase IIb confirmatory study was not powered to show statistical significance, ecabet sodium did achieve statistical significance in the OSDI assessment. There were no reports of serious ocular adverse events compared with the placebo.
In January 2009, we announced positive results from our Phase II study. Patients treated with ecabet sodium achieved a strong positive trend in the objective sign of Tear Film Break-Up Time and a positive trend in the objective sign of the Schirmer Test, which measures the quantity of tears produced. In contrast, there were no trends seen in the placebo group for either objective sign. In addition, there were no trends seen in either group in subjective symptoms as measured by the OSDI or patient’s most bothersome reported symptom. In Phase II tests where observations are not powered to show statistical significance, strong and positive trends are used as indicators of potential efficacy to consider conducting subsequent Phase III studies.
After reviewing the guidance from, and our discussions with, the FDA, we believe that by conducting two successful Phase III environmental clinical studies for improvement in signs, and two successful Phase III controlled chamber clinical studies for the improvement in symptoms, we could receive marketing approval. We are continuing our work on the design of future Phase III studies with ecabet sodium.
In addition to our ophthalmic solution development program, we are developing a proprietary nasal formulation of bepotastine for the treatment of allergic rhinitis. In September 2007, we obtained exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergy symptoms, from Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.). Based upon 2009 data from IMS, we estimate the U.S. allergic rhinitis market to be approximately $2.2 billion in sales, with the nasal antihistamine component comprising about 12% of all prescriptions.
Bepotastine nasal is currently in formulation development, with animal studies planned in 2010. We also plan to initiate human clinical studies during 2010.
Other Product Candidates and Development Activities
In addition to the products presently in human clinical trials, we have a number of products that may be ready for late stage clinical study initiation in the future. These include a strong steroid product candidate to treat ocular inflammation, iganidipine, to enhance ocular nerve blood flow, and a new formulation of latanoprost, a prostaglandin, for the treatment of glaucoma.
We continually evaluate opportunities for late-stage or currently-marketed complementary products and for expansion of our existing ophthalmology, optometry, and allergy product franchises. We plan to continue to pursue such opportunities through further licensing arrangements, collaborations and product acquisitions, along with related development activities. Our ability to execute on such opportunities in some circumstances may be dependent upon our ability to raise additional capital on commercially reasonable terms.
Product Licensing Agreements
Xibrom, Istalol, Bepreve, Ecabet Sodium, Prostaglandins and Iganidipine Agreements With Senju
In May 2002, we acquired substantially all of the assets of AcSentient, Inc., or AcSentient, which included exclusive U.S. development, manufacturing and marketing rights for Istalol and Xibrom. Istalol and Xibrom were originally licensed by AcSentient from Senju. The full rights and obligations of AcSentient under the Senju license agreements were assigned to us as a part of the acquisition agreement between us and AcSentient, with such transfer approved by Senju.
In November 2004, we entered into another license agreement with Senju under which Senju granted to us exclusive U.S. marketing rights to Senju’s ecabet sodium product for the treatment of dry eye syndrome.
In 2006, we entered into three additional license agreements with Senju under which Senju has granted us exclusive North American rights for Bepreve for the treatment of ocular allergy, various prostaglandin products and iganidipine to enhance ocular nerve blood flow.
In December 2009, we renegotiated our bromfenac license agreement with Senju to include, among other things, the expansion of our territory to include Canada and Mexico.
Generally, under the terms of our agreements with Senju, we are responsible for all costs associated with developing the licensed products in ophthalmology for the United States and, with respect to Xibrom, Bepreve, prostaglandins and iganidipine, North America, including clinical trials, regulatory filings, manufacturing, and, if the product is approved, marketing and sales activities.
We have paid to Senju non-refundable milestone payments of $4 million relating to the development process and regulatory approval of both Istalol and Xibrom and are required to pay royalties on product sales.
We have paid to Senju non-refundable milestone payments of $4 million relating to the development process and regulatory approval of Bepreve and are required to pay royalties and milestones on product sales and product sales level achievements.
We will be required to pay to Senju non-refundable milestone payments of up to $3 million, some of which have been paid, if all such milestones relating to the development process and regulatory approval of ecabet sodium are accomplished, and royalties on future product sales.
We will be required to pay Senju non-refundable milestone payments of approximately $8 million, some of which have been paid, if all such milestones relating to the development process and regulatory approval of iganidipine are accomplished, and royalties on future product sales.
We will be required to pay Senju non-refundable milestone payments of approximately $8 million, some of which have been paid, if all such milestones relating to the development process and regulatory approval of a prostaglandin product are accomplished, and royalties on future product sales.
The license agreements with Senju for bromfenac, iganidipine and prostaglandins will terminate upon the later of (i) the last-to-expire licensed patent and (ii) ten years after the first commercial sale of the applicable licensed product. The license agreement with Senju for Istalol will terminate upon the last-to-expire licensed patent. The license agreements with Senju for ecabet sodium and Bepreve will terminate ten years after the later of (i) the last-to-expire licensed patent and (ii) ten years after the first commercial sale of the applicable licensed product.
Bepotastine Nasal Agreement With Mitsubishi Tanabe
In September 2007, we entered into a license agreement with Mitsubishi Tanabe Pharma Corporation under which we were granted exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergic rhinitis. We also obtained the right to develop other nasal bepotastine products, including a fixed combination with a steroid and a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
Generally, under the terms of our agreement with Mitsubishi Tanabe, we are responsible for all costs associated with developing the licensed products in ophthalmology for the United States and, with respect to bepotastine nasal, North America, including clinical trials, regulatory filings, manufacturing, and, if the product is approved, marketing and sales activities.
Under the terms of our bepotastine nasal agreement with Mitsubishi Tanabe, we are required to pay Mitsubishi Tanabe non-refundable milestone payments of approximately $9 million, some of which have been paid, if all such milestones relating to the development process and regulatory approval of bepotastine nasal are accomplished, and royalties on future product sales.
The license agreement with Mitsubishi Tanabe for bepotastine nasal will terminate upon the later of (i) the last-to-expire licensed patent and (ii) ten years after the first commercial sale of the applicable licensed product.
In December 2001, we entered into certain agreements with Otsuka Pharmaceutical Co., Ltd., or Otsuka, with respect to the commercialization of Vitrase in Japan for ophthalmic uses in the posterior region of the eye. Under the terms of our agreements with Otsuka, Otsuka is responsible for preclinical studies, clinical trials, applying for and obtaining regulatory approvals and other development activities for Vitrase for ophthalmic uses in the posterior region of the eye in Japan.
In September 2009, we modified our existing License and Supply Agreements with Otsuka. Among other changes, the Supply Agreement terminated, resulting in us having no future obligation to supply Otsuka with hyaluronidase for injection. As a result, we recognized $3.1 million of previously deferred income primarily related to the termination of that supply agreement.
Marketing and Sales
We continue to expand our commercial infrastructure in connection with the marketing, sale and distribution of our approved products in the United States. In late 2009 and early 2010, we expanded our sales force to a total of approximately 165 sales representatives to support our growing commercial activities.
InVentiv Pharma Services LLC provides us with administrative and other services, including training, analytics, and operational support. We target our commercialization efforts towards ophthalmologists, optometrists and allergists, who are the most prolific prescribers of ophthalmic beta-blockers, anti-inflammatories and allergy medications.
Customers and Distribution
We sell our approved products primarily to drug wholesalers, retailers and distributors, including large chain drug stores, hospitals, clinics, government agencies and managed healthcare providers such as health maintenance organizations and other institutions. These customers comprise a significant part of the distribution network for pharmaceutical products in the United States. This distribution network is continuing to undergo significant consolidation marked by mergers and acquisitions among wholesale distributors and the growth of large retail drug store chains. As a result, a small number of large, wholesale distributors control a significant share of the market, and the number of independent drug stores and small drug store chains has decreased. We expect that consolidation of drug wholesalers and retailers will, on an increasing basis, impact the net sales and gross margins of drug manufacturers and will create other competitive pressures.
We have engaged Cardinal Health PTS, LLC, or Cardinal Health, through its Specialty Pharmaceutical Services group, to act as our exclusive distributor for commercial shipment and distribution of our products to our customers in the United States. In addition to distribution services, Cardinal Health provides us with other related services, including product storage, returns, customer support, and administrative support.
Sales to AmeriSource Bergen Corp., McKesson HBOC and Cardinal Health, Inc. accounted for 17%, 40% and 35%, respectively, of our annual net revenues during 2009. The loss of any of these customers could materially and adversely affect our business, results of operations, financial condition and cash flows. Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not material to our business.
We expect to experience seasonality with respect to sales of our ocular allergy products, specifically Bepreve. We expect larger sales in the spring through late summer and fewer sales in the late fall and winter.
In addition, although our ophthalmic pharmaceutical business is not materially affected by seasonal factors, we have noticed a historical trend with respect to sales. Specifically, our sales have tended to be lower during the first calendar quarter than the preceding fourth quarter.
We have a supply agreement with Senju for bepotastine besilate, which is the active pharmaceutical ingredient in Bepreve. Currently, Senju is our sole source for bepotastine besilate. The active ingredient for Xibrom is also supplied to us under an exclusive agreement from a sole supplier. We have supply agreements with Bausch & Lomb to manufacture commercial quantities of Istalol, Xibrom and Bepreve. Currently, Bausch & Lomb is our sole source for all three products.
Ovine hyaluronidase, the active pharmaceutical ingredient used in Vitrase, is processed in several stages to produce a highly purified raw material for formulation. We had a supply agreement with Biozyme Laboratories, Ltd., or Biozyme, for ovine hyaluronidase. Our supply agreement with Biozyme ended in August 2007. We are developing and are awaiting qualification from the FDA for an onsite hyaluronidase manufacturing facility. We anticipate receiving qualification of the manufacturing facility by the FDA during the first half of 2010. Our success in validating the manufacturing site for production of ovine hyaluronidase cannot be assured. We have a supply agreement with Alliance Medical Products, Inc. to manufacture commercial quantities of Vitrase 200 USP units/mL in sterile solution. Currently, Alliance Medical Products, Inc. is our sole source for Vitrase.
Research and Development
Since our inception, we have made substantial investments in research and development. During the years ended December 31, 2009, 2008 and 2007, we spent $24.9 million, $32.4 million and $32.5 million, respectively, on research and development activities.
We plan to focus our near-term research and development efforts on the later-stage products in our product development pipeline. Building on these development efforts, our goal is to continue our growth as a commercial stage, multi-specialty ophthalmology and allergy pharmaceutical company by developing or acquiring complementary products, either already marketed or in late-stage development. Some licensed or acquired products may require additional research and development activities prior to regulatory approval and commercialization.