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Lpath Granted Key European Patent Related to iSONEP Drug Program

SAN DIEGO, CA--(Marketwire - Dec 5, 2012) - Lpath, Inc. ( NASDAQ : LPTN ), the industry leader in bioactive lipid-targeted therapeutics, received official notification from European Patent Office (EPO) that the company has been issued a key patent covering monoclonal antibodies against sphingosine-1-phosphate (S1P), including sonepcizumab™. S1P is a bioactive lipid that has been validated as a target in multiple disease states.

This newly granted patent, European patent No. 1 948 234, claims, among other things, humanized monoclonal antibodies directed against S1P for use in treating a wide range of ocular conditions, including age-related macular degeneration (AMD), diabetic retinopathy and others.

"This key patent provides exclusivity in Europe for our lead S1P program in wet AMD in which dysfunctional angiogenesis, inflammation and scarring contribute to disease progression," said Roger Sabbadini, Lpath's vice president, founder, and inventor of the granted patent. "It also provides us exclusivity in our pursuit of other ocular disorders where we believe dysfunctional levels of S1P may be involved in pathogenesis of disease." 

ASONEP™ and iSONEP™ are different formulations of sonepcizumab, a first-in-class therapeutic antibody against S1P developed by Lpath's ImmuneY2™ drug-discovery engine. Antibodies developed via this discovery engine are designed to target bioactive signaling lipids, such as S1P, that are involved in the proliferation and spread of cancer, AMD, inflammatory and auto-immune disorders, and many other diseases.

Lpath recently completed two early-stage clinical trials using the two anti-S1P antibody formulations: iSONEP was evaluated in a Phase 1 trial in wet-AMD subjects, and ASONEP was evaluated in a Phase 1 trial in cancer subjects.

Lpath has initiated a Phase 2 clinical trial for iSONEP, called Nexus, which is evaluating the anti-S1P antibody's safety and efficacy in wet-AMD patients. Lpath entered into an agreement with Pfizer ( NYSE : PFE ) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP.

Lpath is also independently pursuing an ASONEP Phase 2 trial in renal cell carcinoma and will open this trial soon.

Lpath was also recently granted a Russian patent (2009120052) and a U.S. patent (8,222,373) with composition and methods claims relating to sonepcizumab.

About Lpath's Patent Portfolio
Over the course of the company's development, Lpath has achieved a broad and deep intellectual property position in the bioactive-lipid area. The company's comprehensive patent portfolio now includes 33 issued patents (including nine international) and 109 patent applications (including 82 international). These patents primarily relate to the use of reagents and methods designed to interfere with the actions of bioactive lipids involved in human disease. Lpath's intellectual property portfolio includes coverage of compositions of matter that specifically bind to sphingolipids and sphingolipid metabolites. These compositions, including antibodies, could be used in the diagnosis and treatment of various diseases and disorders, including cardiovascular and cerebrovascular disease, cancer, inflammation, autoimmune disorders, ocular disease, and angiogenesis.

Lpath has also obtained issued patent claims on sphingolipid targets (e.g., receptors and signaling sphingolipids) and methods for using such targets in drug-discovery screening efforts.

The company believes that its patent portfolio provides broad and commercially significant coverage of antibodies, receptors, enzymes, and other moieties that bind to a lysolipid (or a sphingolipid metabolite) for diagnostic, therapeutic, or screening purposes.

About Lpath
San Diego-based Lpath, Inc., a therapeutic antibody company, is the category leader in lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company has developed three drug candidates: iSONEP™ is currently in a Phase 2 trial for wet AMD; ASONEP™ will soon begin a Phase 2 trial in Renal Cell Carcinoma patients; and Lpathomab is a preclinical drug candidate that holds promise in neuropathic pain, neurotrauma, and other diseases. For more information, visit www.Lpath.com.

About Forward-Looking Statements
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the protection against competition afforded by issued patents; the eventual commercial viability of the Company's drug programs; and the Company's ability to complete additional discovery and development activities for drug candidates utilizing its proprietary ImmuneY2 drug discovery process. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the outcome of the final analyses of the data from the Phase 1 clinical trial may vary from the Company's initial conclusions; the results of any future clinical trials for iSONEP or ASONEP may not be favorable and the Company may never receive regulatory approval for iSONEP or ASONEP or any of its drug candidates; and the Company's may not be able to secure the funds necessary to support its clinical trial and product development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.