VANCOUVER, May 12 /PRNewswire-FirstCall/ - QLT Inc. announced today results from a proof of concept trial conducted by QLT’s wholly-owned subsidiary, QLT Plug Delivery, Inc., of its punctal plug drug delivery technology. The results demonstrated that QLT’s drug elution technology was effective in controlling intraocular pressure (IOP) and was well tolerated.
The proof of concept, open label study was initiated to determine if a sustained administration of latanoprost using the Company’s punctal plug drug delivery technology could lead to a reduction in IOP over 90 days when administered using a conventional plug design. Five patients (10 eyes) with glaucoma or ocular hypertension were enrolled at a single center. The primary efficacy endpoint was measurement of IOP. At baseline, the mean IOP was 23mmHg for the 10 eyes treated. At 90 day follow-up, the mean IOP was reduced to 17mmHg for the six eyes that remained. Data from two patients were excluded due to loss of plugs. No significant adverse events were reported.
“We are very pleased to report positive results from this preliminary proof of concept trial”, said Bob Butchofsky, President and Chief Executive Officer of QLT. “Although the number of patients is small, we are encouraged by the clinically meaningful reduction in IOP that was observed and sustained for approximately 90 days. We look forward to providing you with additional details from this study at our Annual General Meeting on Wednesday, May 14.”
The objective of QLT’s punctal plug program is to demonstrate that the Company’s drug elution technology leads to a statistically significant reduction in IOP for 90 days and that its proprietary punctal plug design can be retained comfortably in a high percentage of patients during that time period. The results presented today are an early indication that QLT’s drug elution technology has the potential to provide a meaningful therapeutic benefit. To generate proof of concept data for the Company’s proprietary punctal plug drug delivery system, QLT is currently enrolling patients in the CORE study, a Phase 2, randomized, double blind trial to assess the safety and efficacy of its latanoprost punctal plug delivery system for the treatment of glaucoma and ocular hypertension at three different doses (low, medium, high). The medium dose of latanoprost in the CORE Study was used in the trial that is being reported today.
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize three unique technology platforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, to create products such as Visudyne(R) and Eligard(R) and future product opportunities. For more information, visit our web site at www.qltinc.com.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol “QLTI” and on The Toronto Stock Exchange under the trading symbol “QLT.”
Certain statements contained in this press release, which are not historical facts, are “forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995 and constitute “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to: our beliefs regarding the potential benefits, targets, market opportunity and commercial success of our punctal plug drug delivery system; our expectations regarding our clinical development plans and strategy for the technology and timelines associated with these; and statements which contain language such as “expects,” “will”, “plans,” “estimates,” “intends,” “believes” and similar expressions that do not relate to historical matters. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from the results expressed or implied by such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: risks and uncertainties associated with the timing, expense and outcome of research and development programs and commercialization of products (including the difficulty of predicting the timing and outcome of the punctal plug development efforts, clinical testing and regulatory approvals or actions); uncertainties regarding the impact of competitive products and pricing; risks and uncertainties associated with the safety and effectiveness of our technology; risks and uncertainties related to the scope, validity, and enforceability of our intellectual property rights and the impact of patents and other intellectual property of third parties; and other factors as described in detail in QLT’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are based on the current expectations of QLT and QLT does not assume any obligation to update such information to reflect later events or developments except as required by law.
CONTACT: QLT Inc.: Vancouver, Canada, Therese Hayes, Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604) 707-7001; The Trout Group: New York, USA, Brandon Lewis, Telephone: (646) 378-2915 or Marcy Strickler, Telephone: (646) 378-2927
CONTACT: QLT Inc.: Vancouver, Canada, Therese Hayes, Telephone: (604)
707-7000 or 1-800-663-5486, Fax: (604) 707-7001; The Trout Group: New York,
USA, Brandon Lewis, Telephone: (646) 378-2915 or Marcy Strickler,
Telephone: (646) 378-2927
