The global dry eye syndrome market size was USD 5.22 billion in 2019 and is projected to reach USD 6.54 billion by 2027, exhibiting a CAGR of 4.7% during the forecast period
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A new first-in-class therapy that is could be submitted to the FDA later this year could signal a new way to treat dry eye disease. Reproxalap, developed by Aldeyra Therapeutics, is a modulator of RASP, a novel anti-inflammatory target for dry eye. A Type B pre-NDA meeting is expected to be held with the FDA in the third quarter of 2022, followed by a potential NDA submission.
RASP (reactive aldehyde species) binds to cellular biomolecules, disrupting their function and activating pro-inflammatory mediators. RASP have been observed to be elevated in ocular and systemic inflammatory diseases.
Reproxalap is a small molecule that reduces excessive RASP levels. Several clinical trials have shown reproxalap demonstrated consistent statistically significant and clinically relevant activity and has the potential for early and broad activity in dry eye disease.
Data from the phase 3 TRANQUILITY-2 clinical trial show that reproxalap was found to be statistically superior to vehicle for each of the two prespecified primary endpoints, including the Schirmer test and the ³10 mm Schirmer Test Responder Analysis, which are measures of ocular tear production.
Dry eye disease is a common inflammatory disease estimated to affect 39 million or more adults in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment.
Aldeyra is also conducting phase 3 trial of reproxalap to treat allergic conjunctivitis. About 100 million patients in the United States have allergic conjunctivitis. Company officials estimate that up to 30 million of these patients either don’t respond adequately to, or are dissatisfied with, topical antihistamines, the current standard of care. Histamine, they said, is only one of the biological mediators of allergic conjunctivitis.
Key players covered in the global Dry Eye Syndrome Market research report:
- ALLERGAN (Dublin, Ireland)
- Alcon (Geneva, Switzerland)
- Novartis AG (Basel, Switzerland)
- Santen Pharmaceutical Co., Ltd. (Japan)
- OASIS Medical (California, U.S.)
- Sun Pharmaceutical Industries Ltd (Mumbai, India)
- Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan)
- Sentiss Pharma Pvt. Ltd. (Haryana, India)
- Johnson & Johnson Vision Care, Inc. (Jacksonville, U.S.)
- VISUfarma (Amsterdam, Netherlands)
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