=Kala Pharmaceuticals (KALA) reported mixed results for its dry eye treatment

• The company reported mixed results for its dry eye treatment -- stoking skepticism on the drug's ability to get regulatory approval. The shares are down 33.4% so far this week, their worst weekly since going public last July.
• KALA stock could be at risk of downgrades going forward, considering each of the four analysts covering the shares maintain a "strong buy" recommendation. Likewise, the average 12-month price target stands at a lofty $32.

Kala Pharmaceuticals announced that the NDA for INVELTYS for the treatment of inflammation and pain in patients who have undergone ocular surgery, has been accepted for review by the FDA 
The FDA, in its 74-day letter, indicates that the application is sufficiently complete to permit a substantive review and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018.

Kala Pharmaceuticals Announces Topline Results for Two Phase 3 Trials  

• Statistical significance achieved for the primary sign endpoint, conjunctival hyperemia at Day 15 in the ITT population, in STRIDE 1  
• Statistical significance achieved for the primary sign endpoint, conjunctival hyperemia at Day 15 in the ITT population, in STRIDE 2  
• Statistical significance achieved for the primary symptom endpoint, ocular discomfort severity at Day 15 in the ITT population, in STRIDE 1 (p<0 .0001="" li="">
• Ocular discomfort severity at Day 15 in the ITT population showed improvement but did not reach statistical significance in STRIDE 2  
• Statistical significance for ocular discomfort severity at Day 15 in patients with more severe baseline discomfort was achieved in STRIDE 1 (p=0.0008), with a trend towards a treatment effect (p=0.0799) in STRIDE 2
• Positive treatment effects observed for ocular discomfort severity in the ITT population at Day 8, a key secondary endpoint in both STRIDE 1 (p=0.0011) and STRIDE 2 (p=0.0408)
• KPI-121 0.25% was well-tolerated with elevations in IOP similar to placebo

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