What is Pinguecula?
Pinguecula is a round, yellowish, elevated tissue that develops on the conjunctiva adjacent to the cornea. Generally speaking, an asymptomatic pinguecula requires no treatment, but its yellowish and raised contour can cause mechanical or poor tear film-related ocular surface irritation. When the lesion becomes vascularized and/or inflamed, it can produce symptoms of ocular discomfort, pain, foreign body sensation, tearing, itching and redness.
At present, there is no drug for pinguecula approved by the FDA.
Lubricating eye drops may be prescribed for those with mild vascularized pinguecula to relieve dry eye irritation and foreign body sensation. To reduce significant inflammation and swelling, non-steroidal anti-inflammatory drugs or steroid eye drops may be needed. However, these off-label drugs are either not effective or not safe for prolonged use. For instance, topical corticosteroid use is limited due to the concern for ocular complications such as glaucoma and cataract. Therefore, there is an unmet medical need to develop a drug to reduce pinguecula vascularity and relieve symptoms.
We formulated a potent VEGFR/PDGFR inhibitor into topical eye drops to treat pinguecula following 505b(2) regulatory pathway.