Aldeyra Therapeutics Inc. has announced that the European Medicines Agency $(EMA)$ has granted Orphan Designation for ADX-2191, their methotrexate intravitreal injection, for the treatment of inherited retinal dystrophies including retinitis pigmentosa. This regulatory milestone underscores the crucial need for effective treatments for retinitis pigmentosa, a rare genetic eye disease that affects over one million people globally. Orphan Designation by the EMA provides Aldeyra with benefits such as reduced regulatory fees and up to 10 years of market exclusivity within the European Union, aiding in the continued development and potential future availability of ADX-2191. This follows a similar Orphan Drug Designation from the U.S. FDA, highlighting the international recognition of the treatment's potential.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.