IRVINE, Calif., May 4 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , today announced it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for T-Pred(TM) (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension). T-Pred is being developed as a topical steroid to treat inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.
"While we are disappointed by the FDA's decision, ISTA is committed to bringing T-Pred to ophthalmologists and patients. We believe our clinical study met the endpoints that ISTA and the FDA agreed to in the Special Protocol Assessment," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "Nonetheless, the FDA did not find sufficient clinical information to merit approval. We plan to work closely with the Agency to resolve this issue in an efficient manner. We intend to request a meeting with the Agency to come to agreement on the actions ISTA must undertake to receive marketing approval for T-Pred."
In the fourth quarter of 2005, ISTA completed its U.S. Phase III clinical study of T-Pred. The study was designed as a multi-center, randomized, double-blind study to determine the bioequivalence of prednisolone concentrations between T-Pred (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension) and PredForte(R) (prednisolone acetate 1.0%). ISTA believes its study demonstrated T-Pred achieved or exceeded this goal both in the intent-to-treat and the per-protocol patient populations. In addition, the Company believes its studies showed T-Pred to have antimicrobial activity equivalent to other combination products approved for this indication.
The FDA assessed the Company's clinical data as not showing sufficient equivalence between the prednisolone component in T-Pred and PredForte at least at one of the time points measured nor equivalence in the kill time between the tobramycin components in T-Pred and Tobrex(R), although it showed equivalence versus Zylet(R) and Tobradex(R). ISTA does not agree with this assessment and plans to request a meeting with the FDA as quickly as possible.
ABOUT ISTA
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to T-Pred's prospects and ISTA's goals of bringing a new product to market every 12 to 18 months and becoming the leading niche ophthalmic pharmaceutical company in the U.S. are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others: timely and successful implementation of ISTA's strategic initiatives; delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of product development efforts and the FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of and demand for ISTA's approved products and the impact of competitive products and pricing; uncertainties and risks related to ISTA's ability to properly manage its growth; uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations and licensing arrangements; uncertainties and risks related to the continued availability of third party sourced products and raw materials on commercially reasonable terms, or at all; uncertainties and risks related to successful compliance with FDA and or other governmental regulations applicable to ISTA's facilities, products and/or business; uncertainties and risks related to the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties; and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2006, and ISTA's Quarterly Report on Form 10-Q for the quarter ended March 31, 2007.
PredForte is a registered trademark of Allergan. Tobrex and Tobradex are registered trademarks of Alcon Laboratories. Zylet is a registered trademark of Bausch & Lomb.
ISTA Pharmaceuticals, Inc.
