The Market for Ophthalmic Drug Products: Clinical and Business Need-Driven

Market research estimates performed in the last 6 months have shown that the market size for ophthalmic medications is expected to reach more than 25 billion, by the year 2015. The ophthalmology drugs market classification is based on the type of drugs: treatment-based drugs, over-the-counter (OTC) drugs and ocular anesthetics. In the last decade, market need has driven the ophthalmic drug development industry to make extraordinary strides forward both in drug design and in ocular delivery. Following the high profile scientific breakthroughs of nucleic acid-based cell-targeted therapies (RNAi, aptamers), highly specific receptor-targeted small molecule therapies, efficient cell-permeating small molecules and pro-drugs, retro-metabolic small molecules and drugs with better safety profiles have been the introduction of intelligent drug delivery systems that claim to deliver to the targeted tissue for the required duration. Combined with these clinical need-driven innovations are a plethora of technologies that are business-driven, aimed at product extensions for life-cycle management of existing products. Each of these extensions offers improvements and benefits over current technologies, such as offering preservative-free options, “non-settling” formulations, etc. From a regulatory perspective, the number of 505(b)(2) applications claiming differentiated technologies have risen dramatically, with fewer NDA (505(b)(1) applications for novel new chemical entities (NCEs) than there were in previous years. The repurposing of previously approved molecules for other indications into products re-formulated and optimized for ophthalmic delivery has the advantage of leveraging long-term relevant safety data in humans, offering a regulatory advantage with the FDA approval process. If differentiated, IP protection is sought after, to gain maximum product life cycle extension for these products. In lock-step with these products is the generic ophthalmic products industry, offering high quality, pharmaceutically-compliant products at an affordable cost. Thus, the ophthalmic products industry continues to seek a fine balance between innovation to meet both business and clinical needs and a relatively short regulatory timeline.