Telor Ophthalmic Pharmaceuticals, Inc. Announces Results from Tekron Phase II Clinical Trial; Further Progress in Surgical Miosis and Presbyopia Clinical Programs.WILMINGTON, Mass.--(BUSINESS WIRE)--Nov. 7, 1994--TELOR OPHTHALMIC PHARMACEUTICALS, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (NASDAQ/NM Symbol: TELR TELR Talker Echo Loudness Rating ) today announced its preliminary analysis of the results of its Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of TEKRON, its topical eye-drop formulation of ethacrynic acid ethacrynic acid /eth·a·cryn·ic ac·id/ (eth-ah-krin´ik) a loop diuretic used in the treatment of edema, including that associated with congestive heart failure or hepatic or renal disease, ascites, and hypertension. (ECA ECA See: Export Credit Agency ). Separately, the Company announced the commencement of a Phase I/II trial for a potential product to maximize pupil size during eye surgery; and the results of its most recent feasibility trial for a pharmacological approach to the treatment of presbyopia Presbyopia Definition The term presbyopia means "old eye" and is a vision condition involving the loss of the eye's ability to focus on close objects. . TEKRON The Phase II trial of TEKRON was conducted to test the efficacy of a topical eye-drop formulation of ECA in reducing intraocular pressure intraocular pressure n. The pressure of the intraocular fluid within the eye. intraocular pressure (in´tr in patients with glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). . TEKRON was administered twice a day for fourteen days at the highest concentration tested in a preceding Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I . In the trial, topical ECA showed no efficacy compared to the placebo in reducing intraocular pressure. Based on these results, the Company does not intend to proceed with further development of a topical formulation of ECA for this indication. Commenting on these findings, Stephen J. Riggi, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of TELOR OPHTHALMIC PHARMACEUTICALS, INC. stated, "The cancellation of the clinical program with TEKRON is clearly a disappointment. After extensive formulation and preclinical development studies, and two series of Phase I and Phase II clinical trials, we must reluctantly conclude that the topical delivery of ECA for the treatment of glaucoma does not appear feasible. However, by determining to discontinue this program, we will maximize our resources available for our other ongoing programs." SURGICAL MIOSIS miosis /mi·o·sis/ (mi-o´sis) contraction of the pupil. mi·o·sis or my·o·sis n. pl. mi·o··ses 1. TELOR has filed an Investigational New Drug (IND) application and started a Phase I/II clinical trial to study a potential pharmaceutical product to maximize pupil size during cataract surgery Cataract Surgery Definition Cataract surgery is a procedure performed to remove a cloudy lens from the eye; usually an intraocular lens is implanted at the same time. Purpose The purpose of cataract surgery is to restore clear vision. . The clinical trial will involve the administration of a formulation of EY-128. When an ophthalmic surgeon operates to remove a cataractous lens and replace it with an artificial lens, the surgeon must operate through the pupil. The pupil, which initially may be only 5-8 mm in diameter, often decreases in size, which is referred to as surgical miosis. The Company believes that EY-128 may have the potential to prevent the release of inflammatory mediators, which may be a cause of surgical miosis. There are approximately 1.5 million cataract surgeries performed each year in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . PRESBYOPIA TELOR also announced the results of its latest testing of the feasibility of a pharmacological treatment of presbyopia, the age-related loss of the ability to focus on near objects, as in reading. TELOR is engaged in a series of studies in humans to evaluate the basic pharmacology of several classes of agents for possible effectiveness in order to progress toward identification of a lead class of compounds for more specific testing. In the most recent study in 24 individuals, 40-50 years of age, agents from two different classes of compounds were tested topically. One agent, administered in a single dose, resulted in a pharmacologically significant improvement in the ability of the eye to focus on near test objects. The other agent, for which a significant effect was seen in a previous study in which it was given as a single dose, was dosed daily for four days, but did not results in a significant response. The Company believes that additional classes of agents must be tested to evaluate this pharmacological approach to the treatment of presbyopia. Commenting on TELOR's product development programs, Dr. Riggi stated, "The termination of one of our clinical programs is an unwelcome event. With topical delivery of ECA not feasible, TELOR will concentrate its activities and resources on the development of our other clinical efforts and preclinical programs. The new clinical program in surgical miosis during cataract surgery is a welcome addition, TELOR is also currently in pivotal, multi-center, Phase III clinical trials of XARANO|, a potential product for preventing elevated intraocular pressure following cataract surgery." TELOR OPHTHALMIC PHARMACEUTICALS, INC. is dedicated to the development and marketing of innovative prescription pharmaceuticals for use in ophthalmic surgery and age related diseases. The Company's strategy is to introduce into the expanding $3.6 billion worldwide ophthalmic market a broad-based portfolio of patent protected products. TELOR is currently focused on chronic therapies for the treatment of presbyopia and ocular pain, and acute use surgical adjuncts for prevention of post operative pressure spikes and surgical miosis, both common problems associated with cataract surgery. CONTACT: Telor Ophthalmic Pharmaceuticals
Stephen J. Riggi, Ph.D., 508/657-8400
Lippert/Heilshorn & Assoc.
Michele Fasano, 212/838-3777, ext. 105
Kristen Mahan, 212/838-3777, ext. 122
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